Davis Drug Guide DIU - 2016 - Combined

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APRIL HAZARD VALLERAND, CYNTHIA A. SANOSKI, BS, PharmD,

PhD, RN, FAAN FCCP, BCPS
Wayne State University Chair, Department of Pharmacy Practice
College of Nursing Thomas Jefferson University
Detroit, Michigan Jefferson School of Pharmacy
Philadelphia, Pennsylvania
JUDITH HOPFER DEGLIN, PharmD

Consultant Pharmacist
Hospice of Southeastern Connecticut
Norwich, Connecticut
Copyright 2016 by F.A. Davis Company. All rights reserved. This book is protected by
copyright. No part of it may be reproduced, stored in a retrieval system or transmitted in any
form or by any means, electronic, mechanical, photocopying, recording, or otherwise,
without written permission from the publisher.
ISBN 10: 0-8036-4452-3
ISBN 13: 978-0-8036-4452-6
Printed in the United States of America.
Note: As new scientific information becomes available through basic and clinical research,
recommended treatments and drug therapies undergo changes. The author(s) and
publisher have done everything possible to make this information accurate, up to date, and
in accord with accepted standards at the time of posting. The authors, editors, and publisher
are not responsible for errors or omissions or for consequences from application of the
information, and make no warranty, expressed or implied, in regard to the contents of the
information. Any practice described in this information should be applied by the reader in
accordance with professional standards of care used in regard to the unique circumstances
that may apply in each situation. The reader is advised always to check product information
(package inserts) for changes and new information regarding dose and contraindications
before administering any drug. Caution is especially urged when using new or infrequently
ordered drugs.
2016 DRUG INFORMATION UPDATE

The 2016 Drug Information Update presents the full pharmacologic profile for 44 newly
approved drugs and is for use by those who have purchased Daviss Drug Guide for
Nurses, 14th Edition and Nurses Med Deck, 14th Edition. Designed for portability, the
update may be inserted inside the Daviss Drug Guide for Nurses or used with the Nurses
Med Deck. This supplement in addition to our postings on www.DrugGuide.com will
completely update the current editions of Daviss Drug Guide and Nurses Med Deck. Having
this Update available precludes the need to purchase another 2015 2016 drug reference
and thereby offers you substantial savings.
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Keep up-to-date at www.DrugGuide.com
Gain free access to new drug monographs, the latest FDA approvals, innovative articles on
pharmacology, drug alerts, dangerous side effects, and potentially life threatening drug-drug,
drug-natural product, and drug-food interactions.
Contents
antihemophilic factor (recombinant) Fc mefloquine (Lariam), 45
fusion protein (Eloctate), 1 meningococcal group B vaccine
belinostat (Beleodaq), 3 (Trumenba), 47
blinatumomab (Blincyto), 4 mixed pollens allergen extract
C1-esterase inhibitor, recombinant (Oralair), 48
(Ruconest), 7 netupitant/palonosetron (Akynzeo), 50
ceftolozane/tazobactam (Zerbaxa), 9 nintedanib (Ofev), 52
coagulation factor IX (Recombinant), Fc nivolumab (Opdivo), 54
fusion protein (Alprolix), 11 olaparib (Lynparza), 56
coagulation factor XIII A-subunit olodaterol (Striverdi), 58
(recombinant) (Tretten), 12 oritavancin (Orbactiv), 60
cobicistat (Tybost), 13 palbociclib (Ibrance), 61
dalbavancin (Dalvance), 17 peginterferon beta-1a (Plegridy), 63
droxidopa (Northera), 19 pembrolizumab (Keytruda), 65
dulaglutide (Trulicity), 20 peramivir (Rapivab), 67
edoxaban (Savaysa), 22 pirfenidone (Esbriet), 68
efinaconazole (Jublia), 25 ramucirumab (Cyramza), 70
eliglustat (Cerdelga), 26 secukinumab (Cosentyx), 72
elosulfase alfa (Vimizim), 28 short ragweed pollen allegen extract
elvitegravir (Vitekta), 30 (Ragwitek), 74
ferric citrate, 32 suvorexant (Belsomra), 76
finafloxacin (Xtoro), 33 timothy grass pollen allergen extract
fomepizole (Antizol), 34 (Grastek), 78
insulin, human inhalation (Afrezza), 35 umclidinium (Incruse, Ellipta), 80
ledipasvir/sofosbuvir (Harvoni), 38 vedolizumab (Entyvio), 81
lenvatinib (Lenvima), 40
lipid emulsion, injectable
(Clinolipid), 43
Table 1 Drugs with New Warnings, 84 Table 4 New Drug Combinations, 89

Table 2 Drugs with New Dosage Forms or Table 5 Other Recently Released
Strengths, 86 Drugs, 91
Table 3 Drugs with New Indications, 88 Table 6 Discontinued Drugs, 91
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antihemophilic factor (recombinant) Fc fusion protein 1

Use Cautiously in: OB: Use only if
antihemophilic factor clearly needed; OB: Use cautiously if
(recombinant) Fc fusion breast feeding; Pedi:qdoses/pinterval
protein may be required in children 2 5 yr due to
(an-teye-hee-moe-feel-ik qclearance.
fak-tor ree-kom-bi-nant Adverse Reactions/Side Effects
eff-cee fyoo-zhun proh- CNS: malaise. MS: arthralgia. Misc: hy-
teen) persensitivity reactions including ANAPHY-
LAXIS, neutralizing antibodies.
Eloctate
Interactions
Classification Drug-Drug: Anticoagulants, throm-
Thera: hemostatic agents bolytics, antiplatelet agents, NSAIDs,
Pharm: clotting factor re- SSRIs, and NSRIs mayqrisk of bleeding.
placements Route/Dosage
One unit/kg body weight willqFactor VIII
Pregnancy Category C level by 2%.
Indications Control/prevention of bleeding
Control/prevent bleeding episodes, peri- episodes
poperative management and routine pro- IV (Adults and Children 6 yr): Minor
phylaxis of bleeding episodes in patients or moderate bleeding (requires Factor
with Hemophilia A (congential Factor VIII VIII level of 40 60% of normal) 20
deficiency). 30 IU/kg every 24 48 hr until bleeding
Action episode is resolved; Major bleeding (re-
Replaces deficient antihemophilic factor quires Factor VIII level of 80 100% of
(AHF, Factor VIII). Produced via recombi- normal) 40 50 IU/kg every 12 24 hr
nant DNA technology, presence of fusion until bleeding episode is resolved (7 10
protein delays degradation. Therapeutic days).
Effects: Decreased incidence and sever- IV (Children 6 yr): Minor or moder-
ity of bleeding in patients with Hemophilia ate bleeding (requires Factor VIII level
A. of 40 60% of normal) 20 30 IU/kg
every 12 hr un-24 until bleeding episode
Pharmacokinetics is resolved; Major bleeding (requires
Absorption: IV administration results in Factor VIII level of 80 100% of nor-
complete bioavailability. mal) 40 50 IU/kg every 8 24 hr until
Distribution: Unknown. bleeding episode is resolved (7 10 days).
Metabolism and Excretion: Un-
known. Perioperative Management
Half-life: Unknown, clearance is more IV (Adults and Children 6 yr): Minor
rapid in children. prodecures (requires Factor VIII level
50 80% of normal) 25 40 IU/kg
TIME/ACTION PROFILE (effects on every 24 hr for 24 hr until healing is
hemostasis) achieved; major prodecures (requires
ROUTE ONSET PEAK DURATION Factor VIII level 80 120% of nor-
IV rapid end of in- 6 hr-5 mal) 40 60 IU/kg pre-operatively fol-
fusion days lowed by 40 50 IU/kg after 8 24 hr and
then every 24 hr to maintain Factor VIII
Depends on patient age and clinical situation. level in desired range, continued until
Contraindications/Precautions wound healing and then for at least 7 days
Contraindicated in: Previous life- to maintain Factor VIII level in desired
threatening hypersensitivity. range.
Canadian drug name. Genetic implication.
*CAPITALS indicates life-threatening; underlines indicate most frequent.
pg 2 Plate
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2 antihemophilic factor (recombinant) Fc fusion protein

IV (Children 6 yr): Minor prodecures Potential Nursing Diagnoses
(requires Factor VIII level 50 80% of Ineffective tissue perfusion (Indications)
normal) 25 40 IU/kg every 12 24 hr Risk for injury (Indications)
for 24 hr until healing is achieved; major Implementation
prodecures (requires Factor VIII level
80 120% of normal) 40 60 IU/kg IV Administration
pre-operatively followed by 40 50 IU/kg Direct IV: Allow medication and dilu-
after 6 24 hr and then every 24 hr to ent to reach room temperature. Follow
maintain Factor VIII level in desired manufacturers recommendations for
range, continued until wound healing and preparation. Do not shake. Reconsti-
then for at least 7 days to maintain Factor tuted solution is clear to slightly opales-
VIII level in desired range. cent and colorless; do not administer
Routine prophylaxis solutions that are discolored or contain
precipitate matter. Infuse as soon as
IV (Adults and Children): 50 IU/kg possible, no longer that 3 hr after re-
every 4 days (range 25 65 IU/kg every constitution. Protect from light; do not
3 5 days), doses up to 80 IU/kg or more refrigerate reconstituted solution.
frequent doses may be required in chil- Rate: Infuse at no greater than 10 mL/
dren 6 yr. min; determine rate by patients com-
Availability fort level.
Lyophilized powder (requires recon- Y-Site Incompatibility: Do not admix
sititution with accompanying dilu- or administer in the same line with any
ent): 250 IU Factor VIII potency/single other medication or solution.
use vial, 500 IU Factor VIII potency/single Patient/Family Teaching
use vial, 750 IU Factor VIII potency/single Instruct patient to notify health care
use vial, 1000 IU Factor VIII potency/sin- professional immediately if bleeding re-
gle use vial, 1500 IU Factor VIII potency/ curs.
single use vial, 2000 IU Factor VIII po- Advise patient to read Patient Informa-
tency/single use vial, 3000 IU Factor VIII tion prior to infusion and with each Rx
potency/single use vial. refill in case of changes.
Instruct patient to notify health care
NURSING IMPLICATIONS professional or go to nearest emergency
Assessment department immediately if signs and
Assess for allergic reaction (angio- symptoms of hypersensitivity reactions
edema, dyspnea, wheezing, tachycardia, occur.
urticaria, hives, chest tightness, pruri- Caution patient to avoid products con-
tus). If symptoms occur discontinue in- taining aspirin or NSAIDs; they may fur-
fusion immediately and treat symtomati- ther impair clotting.
cally. Advise patient to notify health care pro-
Monitor for bleeding during and peri- fessional if signs and symptoms of ad-
odically after therapy. If bleeding does verse reactions or lack of a clinical re-
not stop, inhibitor/neutralizing antibod- sponse occur.
ies may have formed. Advise female patient to notify health
Lab Test Considerations: Monitor care professional if pregnancy is
plasma Factor VIII activity to confirm planned or suspected or if breast feed-
adequate Factor VIII levels are achieved ing.
and maintained. Evaluation/Desired Outcomes
Monitor for development of Factor VIII Decreased incidence and severity of
inhibitors. Perform Bethesda inhibitor bleeding in patients with Hemophilia A.
assay if Factor VIII levels not attained or
bleeding is not controlled following ex-
pected dose.
pg 3 Plate
# 3 # 0-Composite
belinostat 3
reduction required); Moderate/severe he-
belinostat patic impairment or CCr 39 mL/min; OB:
(be-lin-o-stat) Women with child-bearing potential (reli-
Beleodaq able contraception recommended); Pedi:
Safe and effective use in children has not
Classification been established.
Thera: antineoplastics Adverse Reactions/Side Effects
Pharm: histone deacety- CNS: fatigue, dizziness, headache. Resp:
lase inhibitors cough. CV: hypotension, peripheral
Pregnancy Category D edema, phlebitis. GI: HEPATOTOXICITY,
nausea, vomiting, abdominal pain,pap-
Indications petite, constipation, diarrhea. GU:qcre-
Treatment of relapsed/refractory periph- atinine. Derm: pruritus, rash. F and E:
eral T-cell lymphoma (PTCL). hypokalemia. Hemat: ANEMIA, LEUKO-
PENIA, THROMBOCYTOPENIA. Local: infu-
Action sion site pain. Misc: INFESTION, SEPSIS, TU-
Acts as a histone deacetylase (HDAC) in- MOR LYSIS SYNDROME, chills, fever.
hibitor, produces accumulation of acety-
lated histones and other proteins resulting Interactions
in cell cycle arrest/apoptosis of cells; may Drug-Drug: Concurrent use of strong
have affinity for tumor cells. Therapeu- inhibitors of UGT1A1 including ata-
tic Effects: Decreased spread of re- zanvir, gemfibrozil, and indinavir may
lapsed/refractory PCTL. qblood levels and risk of serious toxicity
Pharmacokinetics and should be avoided.
Absorption: IV administration results in Route/Dosage
complete bioavailability. IV (Adults): 1000 mg/m2/day on days
Distribution: Distributes into total body 1 5 of a 21-day cycle. Cycle may be re-
water, minimal tissue distribution; crosses peated until disease progression or unac-
the placenta. ceptable toxicity. Patients with UGT1A1*28
Metabolism and Excretion: Rapidly polymorphism 750 mg/m2 initial dose.
and extensively metabolized by the liver,
primarily by the UGT1A1 enzyme system Availability
with minor metabolism by other systems, Lyophilized powder for intravenous
2% excreted unchanged in urine. injection (requires reconstitution):
Half-life: 1.1 hr. 500 mg/vial.
TIME/ACTION PROFILE (response) NURSING IMPLICATIONS
ROUTE ONSET PEAK DURATION
Assessment
IV unknown unknown 12 mo Monitor for signs and symptoms of in-
Contraindications/Precautions fections (fever, chills, dyspnea, cough).
Contraindicated in: Concurrent use of Do not administer belinostat in patients
strong inhibitors of UGT1A1; OB: Preg- with active infections.
nancy should be avoided (may cause fetal Assess for signs and symptoms of tumor
harm); Lactation: Breast feeding should lysis syndrome in patients with ad-
be avoided. vanced stage disease and/or with high
Use Cautiously in: Advanced stage dis- tumor burden.
ease/large tumor burden (qrisk of Tumor Monitor for nausea, vomiting, and diar-
Lysis Syndrome); Patients with rhea. May require antiemetics and anti-
UGT1A1*28 polymorphism (initial dose diarrheals.
pg 4 Plate
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4 blinatumomab
Lab Test Considerations: May fuse through a 0.22 micron in-line fil-
cause thrombocytopenia, leukopenia, ter. Rate: Infuse over 30 min. If infu-
and/or anemia. Monitor CBC at baseline sion site pain or other infusion-related
and weekly during therapy. Absolute symptoms occur, extend infusion to 45
neutrophil count (ANC) should be 1.0 min.
x 109/L and platelet count 50 x 109/L
prior to each cycle and prior to resum-
Patient/Family Teaching
Instruct patient to read the Patient In-
ing therapy following toxicity. Discon-
tinue in patients who have recurrent formation sheet prior to starting ther-
ANC nadirs 0.5 c 109/L and/or recur- apy and with each cycle in case of
rent platelet count nadirs 25 x 109/L changes.
Advise patient to notify health care pro-
after 2 dose reductions.
If platelet count 25 x 109/L and nadir fessional if signs and symptoms of low
ANC 0.5 x 109/L, continue therapy. If platelet counts (unusual bleeding and
nadir ANC 0.5 x 109/L with any platelet bruising), low red blood cell count
count or platelet count 25 x 109/L (weakness, tiredness, pale skin, dysp-
with any nadir ANC, decrease dose by nea), infection (fever, flu-like symp-
25% to 750 mg/m2. toms, cough, shortness of breath, burn-
Other toxicities must be NCI-CTCAE ing with urination, muscle aches,
Grade 2 or less prior to therapy. Any worsening skin problems), or liver
Grade 3 or 4 adverse reaction, decrease problems (yellowing of skin and whites
dose by 25%; if toxicity is nausea, vom- of eyes, dark urine, itching, pain in up-
iting, and diarrhea only decrease dose if per right stomach area).
duration is 7 days with supportive Instruct patient to notify health care
care. professional of all Rx or OTC medica-
May cause hepatotoxicity. Monitor liver tions, vitamins, or herbal products be-
function tests before therapy and at start ing taken and to consult health care
of each cycle. Interrupt or adjust dose professional before taking other Rx,
until recovery or permanently discon- OTC, or herbal products.
tinue if severe. Advise patient that this medication may
have teratogenic effects. Contraception
Potential Nursing Diagnoses should be used during therapy. Advise
Risk for infection (Adverse Reactions) female patient to avoid breast feeding.
Diarrhea (Adverse Reactions) Emphasize the need for periodic lab
Implementation tests to monitor for side effects.
Solution should be prepared in a bio-
logic cabinet. Wear gloves, gown, and Evaluation/Desired Outcomes
Decreased spread of relapsed/refrac-
mask while handling medication. Dis-
card IV equipment in specially desig- tory of peripheral T-cell lymphoma.
nated containers (see Appendix L).
IV Administration blinatumomab
Intermittent Infusion: Reconstitute (bli-ni-too-moe-mab)
each vial of belinostat by adding 9 mL Blincyto
Sterile Water for injection into vial for a
concentration of 50 mg/mL. Swirl until Classification
no particles are visible. Reconstituted Thera: antineoplastics
solution may be stored at room temper- Pharm: T-cell engagers
ature for up to 12 hr. Diluent: With-
draw volume needed and inject into Pregnancy Category C
250 mL of 0.9% NaCl. Diluted solution
may be kept at room temperature for Indications
up to 36 hr. Do not use solutions that Treatment of Philadelphia chromosome-
are cloudy or contain a precipitate. In- negative relapsed/refractory B-cell pre-
pg 5 Plate
# 5 # 0-Composite
blinatumomab 5
cursor acute lymphoblastic leukemia ITY, tremor. Misc: CYTOKINE RELEASE SYN-
(ALL). DROME, FEBRILE NEUTROPENIA/INFECTIONS ,
Action HYPERSENSITIVITY REACTIONS, TUMOR LYSIS
Acts as a T-cell engager, binding to and SYNDROME, chills, fever, infusion reac-
activating T-cells binding them to tumor tions.
cells resulting in facilitated lysis of malig- Interactions
nant cells. Therapeutic Effects: Deple- Drug-Drug: May suppress activity of
tion of B-cells, including malignant ones. CYP450 drug-metabolizing enzymes (es-
Pharmacokinetics pecially first 9 days of first cycle and first
Absorption: IV administration results in two days of second cycle), careful moni-
complete bioavailibility. toring of drugs that are substrates of
Distribution: Unknown. CYP450, including cyclosporine and
Metabolism and Excretion: Catabo- wafarin, is recommended.
lized into small peptides and amino acids. Route/Dosage
Half-life: 2.11 hr. IV (Adults 45 kg): Cycle 1 9 mcg/
TIME/ACTION PROFILE (depletion of day as a continuous infusion for days 1 7,
followed by 28 mcg/day as a continuous
B-cells) infusion for days 8 28, followed by a two
ROUTE ONSET PEAK DURATION week treatment-free interval. Subsequent
IV rapid unknown persists dur- cycles 28 mcg/day for days 1 28, fol-
ing treat- lowed by a two week treatment-free inter-
ment free val. Treatment course is up to two cycles
interval for induction followed by three additional
cycles (total of five cycles).
Contraindications/Precautions
Contraindicated in: Hypersensitivity; Availability
CCr 30 ml/min; Lactation: discontinue Lyophilized powder for injection (re-
blinatumomab or discontinue breast feed- quires reconstitution): 35 mcg/vial (IV
ing. solution stabilizer provided with pack-
Use Cautiously in: Geri: Increased risk age).
of neurologic toxicity; OB: Use during
pregnancy only if maternal benefit justifies NURSING IMPLICATIONS
risk to the fetus; Pedi: limited experience, Assessment
safe use not established. Monitor for signs and symptoms of cy-
Adverse Reactions/Side Effects tokine release syndrome (pyrexia, fe-
CNS: SEIZURES, dizziness, fatigue, head- ver, headache, nausea, asthenia, hypo-
ache, insomnia, aphasia, cognitive disor- tension,qAST,qALT,qbilirubin)
der, confusion, leukoencephalopathy, during infusion. May be similar to infu-
weakness. Resp: cough, dyspnea. CV: sion reactions. If symptoms are Grade 3
chest pain, hypotension, peripheral withhold blinatumomab until resolved,
edema, hypertension, tachycardia. GI: ab- then restart at 9 mcg/day. Escalate to 28
dominal pain,pappetite, constipation, di- mcg/day after 7 days if toxicity does not
arrhea, vomiting,qliver enzymes. Derm: recur. If Grade 4 symptoms occur, dis-
rash. Endo: hyperglycemia. F and E: hy- continue blinatumomab permanently.
pokalemia, hypomagnesemia, hypophos- Monitor for signs and symptoms of neu-
phatemia. Hemat: NEUTROPENIA, anemia, rological toxicity (encephalopathy, con-
palbumin,pimmunoglobulins, throm- vulsions, speech disorders, distur-
bocytopenia, leukocytosis, lymphopenia. bances in consciousness, confusion,
MS: arthralgia, back pain, bone pain, ex- disorientation, loss of balance and co-
tremity pain. Neuro: NEUROLOGIC TOXIC- ordination) during therapy. Discon-
pg 6 Plate
# 6 # 0-Composite
6 blinatumomab
tinue blinatumomab permanently if cle or when restarting infusion after in-
more than 1 seizure occurs. If Grade 3 terruption of 4 or more hr.
symptoms occur, withhold blinatu- If an interruption due to an adverse re-
momab until no more than Grade 1 action is 7 days, continue same cycle
(mild) and for at least 3 days, then re- to a total of 28 days inclusive of days be-
start blinatumomab at 9 mcg/day. Esca- fore and after interruption. If interrup-
late dose to 28 mcg/day after 7 days if tion 7 days, start a new cycle.
toxicity does not recur. If toxicity oc- If questions occur regarding reconstitu-
curred at 9 mcg/day or takes 7 days to tion and preparation, call 1-800-AM-
resolve, discontinue blinatumomab per- GEN or 1-800-772-6436.
manently. If Grade 4 symptoms occur, Solution should be prepared in a bio-
discontinue blinatumomab perma- logic cabinet. Wear gloves, gown, and
nently. mask while handling medication. Dis-
Assess for signs and symptoms of infec- card IV equipment in specially desig-
tion (fever, chills, sepsis, pneumonia, nated containers (see Appendix L).
bacteremia, opportunistic infections, Continuous Infusion: Do not flush
catheter site infections) during therapy. line, especially when changing
Treat with anti-infectives as needed. bags or at completion of infusion;
Monitor for signs and symptoms of tu- may result in excess or overdose.
mor lysis syndrome (abdominal pain Use a pre-filled 250 mL 0.9% NaCl poly-
and distension, dysuria, oliguria, flank olefin, PVC non-di-ethylhexylphalate
pain, hematuria, anorexia, vomiting, (non-DEHP), or ethyl vinyl acetate
cramps, seizures, spasms, altered con- (EVA) bag.
sciousness) during therapy. May use Stabilizer is used to coat prefilled IV
prophylactic nontoxic cytoreduction bag; add IV stabilizer to bag, do not use
and on-treatment hydration. May re- for reconstitution.
quire temporary interruption or discon- Entire volume of admixed blinatu-
tinuation. momab will be more than 240 mL vol-
Lab Test Considerations: Monitor ume administered to patient to account
CBC periodically during therapy. May for priming and ensure patient received
cause neutropenia. Interrupt therapy if
full dose. Remove air from infusion bag.
neutropenia is prolonged.
Add or remove 0.9% NaCl from bag if
Monitor ALT, AST, gamma-glutamyl
transferase (GGT), and total serum bili- needed to adjust volume to 265 to 275
rubin prior to starting and during ther- mL.
Using 10 mL syringe, transfer 5.5 mL of
apy. If AST and ALT increase to 5
times the upper limit of normal or if bil- IV solution stabilizer to IV bag. Gently
irubin rises to 3 times the upper limit mix; avoid foaming. Discard remaining
of normal interrupt therapy. stabilizer.
May cause hypokalemia, hypomagnese- Reconstitute blinatumomab, using 3 mL
mia, hyperglycemia, and hypophospha- preservative-free Sterile Water for Injec-
temia. tion/vial for a concentration of 12.5 mg/
mL. Direct solution toward side of vial;
Potential Nursing Diagnoses gently swirl to avoid foaming. Do not
Deficient knowledge, related to medica- shake. Solution should be clear to opal-
tion regimen (Patient/Family Teaching) escent; do not infuse solutions that are
Implementation discolored or contain a precipitate. Vi-
Patient must be hospitalized for first 9 als are stable at room temperature for 4
days of first cycle and first 2 days of sec- hr or 24 hr if refrigerated. For 9 mcg/
ond cycle. For other cycles, supervision day infused over 24 hr at a rate of 10
by healthcare professional is recom- mL/hr, transfer 0.83 mL of reconsti-
mended. tuted solution into IV bag. For 9 mcg/
Premedicate with dexamethasone 20 day infused over 48 hr at a rate of 5
mg IV 1 hr prior to first dose of each cy- mL/hr, transfer 2.6 mL of reconstituted
Name /bks_53956_deglin_diu2016/53956_monos 03/26/2015 02:36PM
pg 7 Plate
# 1 # 0-Composite
C1-esterase inhibitor, recombinant 7

solution into IV bag. For 28 mcg/day professional before taking other Rx,
infused over 24 hr at a rate of 10 mL/ OTC, or herbal products.
hr, transfer 2.6 mL of reconstituted so- Advise female patient to notify health
lution into IV bag. For 28 mcg/day in- care professional if pregnancy is
fused over 48 hr at a rate of 5 mL/hr, planned or suspected or if breast feed-
transfer 5.2 mL of reconstituted solu- ing.
tion (2.7 mL from one vial and 2.5 mL
from a second vial) into IV bag. Diluted Evaluation/Desired Outcomes
solution is stable for 48 hr at room tem- Decrease in progression of Philadelphia
perature or for 8 days if refrigerated. chromosome-negative relapsed/refrac-
Rate: Infuse via programmable, locka- tory B-cell precursor acute lymphoblas-
ble, non-elastomeric infusion pump tic leukemia (ALL).
with an alarm. Infuse 240 mL over 24
or 48 hr based on pharmacy label, at a
rate of 10 mL/hr for 24 hr or 5 mL/hr
for 48 hr. Use tubing that is sterile, non- C1-esterase inhibitor,
pyrogenic, low protein-binding, with a recombinant
0.2 micron in-line filter. Ensure tubing (C1 es-ter-ase in-hib-it-or
is compatible with infusion pump. re-kom-bin-ant)
Patient/Family Teaching Ruconest
Explain schedule for blinatumomab ad- Classification
ministration. Instruct patient to reach Thera: replacement en-
Medication Guide before starting ther-
apy and before each cycle in case of zyme inhibitors
changes. Pharm: enzyme inhibitors
Instruct patient in how to keep area
Pregnancy Category B
around IV catheter clean to reduce in-
fections. Advise patient not to change
settings of infusion pump. Indications
May cause seizures and loss of con- Treatment of acute attacks of hereditary
sciousness. Caution patient to avoid angioedema (HAE).
driving or other activities requiring
alertness until response from medica- Action
tion is known. Replaces malfunctioning or missing C1 es-
Advise patient to notify health care pro- terase inhibitor in patients with HAE. Sup-
fessional immediately if signs and symp- pression of the contact activation system
toms of cytokine release syndrome (fe- by C1-esterase inihibitor prevents the cas-
ver, tiredness or weakness, dizziness, cade of events that leads to attacks of angi-
headache, low blood pressure, nausea, oedema in HAE that are marked by in-
vomiting, chills, facial swelling, wheez- creased vascular permeability, swelling,
ing or difficulty breathing, rash) or neu- edema and laryngospasm. Therapeutic
rological problems (seizures, difficulty Effects: Lessened severity of HAE.
speaking or slurred speech, loss of con-
sciousness, confusion, disorientation, Pharmacokinetics
loss of balance) or if side effects occur Absorption: IV administration results in
that are bothersome or persistent. complete bioavailability.
Instruct patient to notify health care Distribution: Unknown.
professional of all Rx or OTC medica- Metabolism and Excretion: Un-
tions, vitamins, or herbal products be- known.
ing taken and to consult health care Half-life: 2.4 2.7 hr.
pg 8 Plate
# 1 # 0-Composite
8 C1-esterase inhibitor, recombinant

TIME/ACTION PROFILE (symptom urticaria, chest tightness, wheezing, hy-
relief) potension, anaphylaxis) during or after
injection.
ROUTE ONSET PEAK DURATION Monitor for thromboembolic events in
IV within 1 hr unknown 1624 hr patients with risk factors (indwelling ve-
nous catheter/access device, prior his-
Contraindications/Precautions tory of thrombosis, underlying athero-
Contraindicated in: Known/suspected sclerosis, use of oral contraceptives,
hypersensitivity to rabbits/rabbit-derived morbid obesity, immobility) during and
products; Previous immediate hypersensi- after administration.
tivity reactions to C1 esterase inhibitor
preparations. Potential Nursing Diagnoses
Use Cautiously in: Risk factors for Ineffective airway clearance (Indications)
thrombotic events; OB, Lactation: Use dur- Implementation
ing pregnancy/lactation only if clearly IV Administration
needed; Pedi: Safe and effective use in
children 13 yr has not been established, Intermittent Infusion: Ensure c1 es-
increased risk of adverse reactions in chil- terase inhibitor (recombinant) and dil-
dren 13 17 yr). uent are at room temperature before
mixing. Reconstitute by withdrawing 14
Adverse Reactions/Side Effects mL of Sterile Water for Injection. Add
CNS: headache (qin children 13 17 yr). diluent slowly; avoid forceful impact on
EENT: oropharyngeal pain (qin children powder. Swirl slowly to mix; avoid
13 17 yr). CV: THROMBOEMBOLIC foaming. Repeat with second vial. Solu-
EVENTS. GI: abdominal pain (qin chil- tion should be clear and colorless; do
dren 13 17 yr), diarrhea, nausea. Misc: not administer solutions that are discol-
hypersensitivity reactions including ored or contain particulate matter. Use
ANAPHYLAXIS AND EXACERBATION OF solution immediately or may be refrig-
HAE. erated up to 8 hr; do not freeze. Rate:
Interactions Inject slowly over 5 min.
Drug-Drug: None noted. Y-Site Incompatibility: Do not mix
with other medications or solutions.
Route/Dosage
IV (Adults and adolescents 84 kg): Patient/Family Teaching
4200 IU, a second may be given if symp- Explain purpose of medication to pa-
toms persist (not to exceed two doses/24 tient. Advise patient to read Patient
hr). Package Insert.
IV (Adults and adolescents 84 kg): May be self-administered with proper
50 IU/kg, a second may be given if symp- training. Patient must be able to recog-
toms persist (not to exceed two doses/24 nize the signs and symptoms of HAE and
hr). must have the dexterity and compre-
hension to self-administer injection. In-
Availability struct patient using directions in Pa-
Lyophilized powder for intravenous tient Package Insert. Advise patient to
use (requires reconstitution): 2100 seek medical attention immediately in
IU/vial. addition to injection due to potential.
NURSING IMPLICATIONS for laryngeal edema. Instruct patient to
record lot number from vial. At first
Assessment sign of HAE attack, prepare injection.
Assess for signs (facial, laryngeal, or Bring c1-esterase inhibitor with you to
abdominal swelling, dyspnea, pain, health care facility. Notify health care
nausea, vomiting, cramps, diarrhea) professional immediately if swelling
and frequency of HAE. does not decrease after injection.
Monitor for signs and symptoms of se- Advise patient to notify health care pro-
vere hypersensitivity reactions (hives, fessional immediately of signs of hyper-
pg 9 Plate
# 9 # 0-Composite
ceftolozane/tazobactam 9
sensitivity reactions or thrombosis (new Pharmacokinetics
onset of swelling and pain in limbs or Absorption: IV administration results in
abdomen, new onset of chest pain, complete bioavailability.
shortness of breath, loss of sensation or Distribution: Unknown.
motor power, altered consciousness, vi- Metabolism and Excretion: Ceftoloz-
sion, or speech) occur. ane minimal metabolism, excreted al-
Caution patient to consult health care most entirely (95%) unchanged in
professional of planning to travel. urine; tazobactam 80% excreted un-
Advise female patients to notify health changed in urine, some metablized to an
care professional if pregnancy is inactive M1 metabolite which is excreted
planned or suspected or if breast feed- unchanged in urine.
ing. Half-life: Ceftolozane 2.8 hr; tazo-
Evaluation/Desired Outcomes bactam 0.9 hr.
Decrease in intensity of symptoms of TIME/ACTION PROFILE
HAE.
IV rapid end of in- 8 hr
ceftolozane/tazobactam fusion
(sef-tol-o-zane/taz-oh-bak- Contraindications/Precautions
tam) Contraindicated in: Known serious hy-
Zerbaxa persensitivity to ceftolozane/tazbactam, pi-
Classification peracillin/tazobactam or other beta-lac-
tams.
Thera: anti-infectives Use Cautiously in: CCr 30 50 mL/
Pharm: cephalosporin de- min (effectiveness may bep, adjust dose if
rivatives, beta-lactamase necessary); CCr 50 mL/min (dose ad-
inhibitors justment recommended); OB: Use during
pregnancy only if potential benefit out-
Pregnancy Category B weighs potential risks; Lactation: Use cau-
tiously if breast feeding; Pedi: Safe and ef-
Indications fective use in children has not been
Treatment of complicated intra-abdominal established.
infections (with metronidazole) and com- Adverse Reactions/Side Effects
plicated urinary tract infections (including CNS: anxiety, dizziness, headache, insom-
pyelonephritis). nia. CV: atrial fibrillation, hypotension.
Action GI: abdominal pain, constipation, diar-
Ceftolozane: binds to bacterial cell wall rhea, CLOSTRIDIUM DIFFICILE-ASSOCIATED
membrane, causing cell death. Spectrum DIARRHEA (CDAD), nausea, vomiting.
is extended compared with other penicil- Derm: rash. F and E: hypokalemia. He-
lins. Tazobactam: Inhibits beta-lactamase, mat: anemia, thrombocytosis. Misc: hy-
an enzyme that can destroy penicillins. persensitivity reactions including ANAPHY-
LAXIS.
Therapeutic Effects: Death of suscepti-
ble bacteria. Spectrum: Active against Interactions
Enterobacter cloacae, Escherichia coli, Drug-Drug: None noted.
Klebsiella oxytoca, Klebsiella pneum- Route/Dosage
niae, Proteus mirabilis, Pseudomonas IV (Adults): 1.5 g (1 g ceftolozane/0.5 g
aeruginosa, Bacteroides fragilis, Strep- tazobactam) every 8 hr for 4 14 days for
tococcus anginosus, Streptococcus con- intra-abdominal infections or 7 days for
stellatus, and Streptococcus salivarius. urinary tract infections.
pg 10 Plate
# 1 # 0-Composite
10 ceftolozane/tazobactam
Renal Impairment Potential Nursing Diagnoses
(Adults): CCr 30 50 mL/min 750 mg Risk for infection (Indications, Side Ef-
(500 mg ceftolozane/250 mg tazobactam) fects)
every 8 hr; CCr 15 29 mL/min 375 Diarrhea (Adverse Reactions)
mg (250 mg ceftolozane/125 mg tazobac- Implementation
tam) every 8 hr; End-stage renal disease
on hemodialysis Single loading dose of IV Administration
750 mg (500 mg ceftolozane/250 mg ta- Intermittent Infusion: Reconstitute
zobactam), then 150 mg (100 mg cefto- with 10 mL of sterile water for injection
lozane/50 mg tazobactam every 8 hr (on or 0.9% NaCl for injection; shake gently
dialysis days administer as soon as possi- to dissolve for final volume of 11.4 mL.
ble after dialysis). Diluent: Withdraw 11.4 mL for 1.5 g
Availability (1.0 g/0.5 g dose, 5.7 mL for 750 mg
Powder for intravenous injection (500 mg/250 mg) dose, 2.9 mL for 375
(requires reconstitution): 1 g ceftoloz- mg (250 mg/125 mg) dose, or 1.2 mL
ane/0.5 g tazobactam per vial. for 150 mg (100 mg/50 mg) dose and
add to 100 mL of 0.9% NaCl or D5W.
NURSING IMPLICATIONS Solution is clear, colorless to slightly
yellow; do not administer solutions that
Assessment are discolored or contain particulate
Assess for infection (vital signs; appear-
matter. Solution is stable for 24 hr at
ance of wound, sputum, urine, and room temperature or 7 days if refriger-
stool; WBC) at beginning of and ated; do not freeze. Rate: Infuse over 1
throughout therapy. hr.
Before initiating therapy, obtain a his-
Additive Incompatibility: Do not mix
tory to determine previous use of and with other drugs or solutions.
reactions to penicillins, cephalosporins,
or other beta-lactams. Persons with a Patient/Family Teaching
negative history of sensitivity may still Explain the purpose of ceftolzane/tazo-
have an allergic response. bactam to patient.
Obtain specimens for culture and sen- Instruct patient to notify health care
sitivity before initiating therapy. First professional if fever and diarrhea de-
dose may be given before receiving velop, especially if stool contains blood,
results. pus, or mucus. Advise patient not to
Observe patient for signs and symp- treat diarrhea without consulting health
toms of anaphylaxis (rash, pruritus, care professional.
laryngeal edema, wheezing). Discon- Advise female patient to notify health
tinue the drug and notify health care care professional if pregnancy is
professional immediately if these planned or suspected or if breast feed-
symptoms occur. Keep epinephrine, ing.
an antihistamine, and resuscitation Evaluation/Desired Outcomes
equipment close by in the event of an Resolution of the signs and symptoms of
anaphylactic reaction. infection. Length of time for complete
Monitor bowel function. Diarrhea, ab- resolution depends on the organism
dominal cramping, fever, and bloody and site of infection.
stools should be reported to health care
professional promptly as a sign of
(CDAD). May begin up to several mo
following cessation of therapy.
Lab Test Considerations: Monitor
creatinine clearance at least daily in pa-
tients with changing renal function and
adjust dose accordingly.
pg 11 Plate
# 1 # 0-Composite
coagulation factor IX (Recombinant), Fc fusion protein 11

ration of action (qdose/kg or more fre-
coagulation factor IX quent dosing may be required).
(Recombinant), Fc
fusion protein Adverse Reactions/Side Effects
(ko-a-gyoo-lay-shun fac- CNS: headache. CV: THROMBEMBOLISM
(qrisk with continuous infusion via cen-
tor nine eff-cee fyoo-zhun tral catheter). GI: perioral paresthesia.
proh-teen) Misc: hypersensitivity reactions including
Alprolix ANAPHYLAXIS, production of neutralizing
Classification antibodies (inhibitors).
Thera: hemostatic agents Interactions
Pharm: clotting factor re- Drug-Drug: Bleeding risk may beqby
placements anticoagulants, antiplatelet agents,
aspirin, fibrinolytics, NSAIDs, SSRIs
Pregnancy Category C and SNRIs.
Indications Route/Dosage
Factor IX replacement (DNA-derived) to
control and prevent bleeding episodes One unit/kg increases circulating
perioperatively or prophylactically in pa- Factor IX (FIX) level by 1%.
tients with Hemophilia B. IV (Adults and Children): Minor and
moderate bleeding amount needed to
Action produce a circulating FIX level of 30 40
Replaces deficient Factor IX in patients
IU/dL, repeated every 48 hr as needed;
with Hemophilia B. Therapeutic Ef-
Major bleeding amount needed to pro-
fects: Decreased incidence and severity duce a circulating FIX level of 80 100 IU/
of bleeding .
dL, repeat after 6 10 hr, then every 24 hr
Pharmacokinetics for three days, then every 48 hr until heal-
Absorption: IV administration results in ing occurs; Perioperative management
complete bioavailability. (minor procedures) amount needed
Distribution: Unknown. to produce a circulating FIX level of 50
Metabolism and Excretion: Used up 80 IU/dL as a single infusion, may be re-
in clotting process. peated after 24 48 hr until bleeding
Half-life: Adults 86.5 hr; children ceases and healing has occurs; Periopera-
12 17 yr 84 hr; children 6 11 yr tive management (major proce-
72.2 hr; children 2 5 yr 66.4 hr. dures) amount needed to produce a
TIME/ACTION PROFILE (decreased circulating FIX level of 60 100 IU/dL as a
single infusion, may be repeated after 6
bleeding/risk of bleeding) 10 hr and then every 24 for 3 days until
ROUTE ONSET PEAK DURATION bleeding ceases and healing occurs (addi-
IV rapid unknown 648 hr tional doses may be given every 48 hr if
needed); Routine prophylaxis 50 IU/
Up to 10 days when used prophylactically. kg once weekly or 100 IU/kg every 10
Contraindications/Precautions days. Doses may be modified according to
Contraindicated in: Known hypersen- need/response.
sitivity.
Use Cautiously in: OB: Use in preg- Availability
nancy only if clearly needed; Lactation: Lyophilized powder for IV injection
Use caution if breast feeding; Pedi: Chil- (requires reconstitution): 500 IU vial,
dren 12 yr haveqclearance, shorter du- 1000 IU vial, 2000 IU vial, 3000 IU vial.
pg 12 Plate
# 12 # 0-Composite
12 coagulation factor XIII A-subunit (recombinant)

NURSING IMPLICATIONS planned or suspected or if breast feed-
ing.
Assessment
Assess for signs and symptoms of aller- Evaluation/Desired Outcomes
gic reactions (angioedema, chest tight- Control and prevention of bleeding in
ness, hypotension, rash, nausea, vomit- adults and children with Hemophilia B.
ing, paresthesia, restlessness, wheezing,
dyspnea). If symptoms occur, discon- coagulation factor XIII
tinue therapy and treat symptomatically. A-subunit (recombinant)
Lab Test Considerations: If ex-
pected Factor IX activity levels are not
(ko-ag-yoo-lay-shun fak-
attained or if bleeding is not controlled tor thir-teen A sub-yoo-nit
with recommended dose, perform a Be- re-kom-bi-nant)
thesda assay to determine if inhibitors Catridecacog, Tretten
are present.
Classification
Potential Nursing Diagnoses Thera: hemostatic agents
Ineffective tissue perfusion (Indications)
Deficient knowledge, related to medica-
Pharm: clotting factor re-
tion regimen (Patient/Family Teaching) placements
Implementation Pregnancy Category C
IV Administration
Indications
Direct IV: Allow medication and dilu- Prevention of bleeding in patients with
ent to come to room temperature be- congenital factor XIII A-subunit deficiency.
fore use. Follow manufacturers guide-
lines for mixing. Final solution should Action
be clear to slightly opalescent and col- Replaces deficient factor XIII A-subunit
orless. Do not shake. Do not use solu- (produced by recombinant DNA technol-
tions that are discolored or contain par- ogy). Therapeutic Effects: Decreased
ticulate matter. Use reconstituted bleeding.
solution within 3 hr. Do not refrigerate Pharmacokinetics
or freeze after reconstitution. Do not Absorption: IV administration results in
administer reconstituted solution in complete bioavalability.
same tubing or container with other Distribution: Unknown.
medications. Vials can be stored at Metabolism and Excretion: Un-
room temperature for up to 6 mo and known.
then should be discarded; do not return Half-life: Patients 7 58 yr 5.1 days;
to refrigerator. Rate: Administer as a patients 1 6 yr 7.1 days.
bolus infusion over several min. Deter-
mine rate based on patients comfort; TIME/ACTION PROFILE (effect on
no 10 mL/min. Factor XIII A subunit activity)
Patient/Family Teaching ROUTE ONSET PEAK DURATION
May be self-administered with proper IV rapid unknown up to a mo
training. Instruct patient to read Patient
Information and Instructions for Use Contraindications/Precautions
prior to starting therapy and with each Contraindicated in: Hypersensitivity.
refill in case of changes. Use Cautiously in: Lactation: Use cau-
Advise patient to notify health care pro- tiously if breast feeding; OB: Use in preg-
fessional immediately if signs and symp- nancy only if clearly needed.
tom of allergic reactions. Adverse Reactions/Side Effects
Advise female patient to notify health CNS: headache. CV: THROMBOEMBOLISM.
care professional if pregnancy is Local: injection site pain. MS: extremity
pg 13 Plate
# 13 # 0-Composite
cobicistat 13
pain. Misc: allergic reactions including solution within 3 hr. Do not refrigerate
ANAPHYLAXIS,qD dimer, production of or freeze after reconstitution. Do not
neutralizing antibodies. administer reconstituted solution in
Interactions same tubing or container with other
Drug-Drug: Should not be administered medications. Vials can be stored at
with recombinant factor VIIa. room temperature for up to 6 mo and
then should be discarded; do not return
Route/Dosage to refrigerator. Rate: Administer at a
IV (Adults and Children): 35 IU/kg rate not to exceed 1 2 mL/min. Do not
once monthly (to achieve target XIII activ- administer as a drip.
ity 10%); dose may be adjusted as nec- Y-Site Incompatibility: Do not ad-
essary. minister with other infusion solutions.
Availability Patient/Family Teaching
Lyophilized powder for IV use (re- Instruct patient to read Patient Infor-
quires reconstitution, may be further mation and Instructions for Use prior
diluted): . to starting therapy and with each refill
in case of changes.
NURSING IMPLICATIONS Advise patient to notify health care pro-
Assessment fessional immediately if signs and symp-
Assess for signs and symptoms of aller- tom of allergic reactions or a blood clot
gic reactions (angioedema, chest tight- (pain, swelling, warmth, redness, lump
ness, hypotension, rash, nausea, vomit- in legs or arms, chest pain, sudden se-
ing, paresthesia, restlessness, wheezing, vere headache, loss of consciousness or
dyspnea). If symptoms occur, discon- function) occur.
tinue therapy and treat symptomatically. Instruct patient to notify health care
Monitor for thromboembolic events in professional of all Rx or OTC medica-
patients with risk factors (indwelling ve- tions, vitamins, or herbal products be-
nous catheter/access device, prior his- ing taken and to consult health care
tory of thrombosis, underlying athero- professional before taking other Rx,
sclerosis, use of oral contraceptives, OTC, or herbal products.
morbid obesity, immobility) during and Advise female patient to notify health
after administration. care professional if pregnancy is
Lab Test Considerations: Monitor planned or suspected or if breast feed-
for inhibitory antibodies. May manifest ing.
as inadequate response to therapy or Evaluation/Desired Outcomes
breakthrough bleeding during prophy- Decrease in bleeding in patients with
laxis. Perform assay measuring Factor congenital factor XIII A-subunit defi-
XIII inhibitory antibody concentrations. ciency.
Potential Nursing Diagnoses
Ineffective tissue perfusion (Indications)
cobicistat (koe-bis-i-stat)
Implementation Tybost
Direct IV: Allow medication and dilu-
ent to come to room temperature be- Classification
fore use. Follow manufacturers guide- Thera: pharmacoenhancer-
lines for mixing. Final solution should santiretrovirals
be clear to slightly opalescent and col-
orless. Do not shake. Do not use solu- Pharm: enzyme inhibitors
tions that are discolored or contain par- Pregnancy Category B
ticulate matter. Use reconstituted
pg 14 Plate
# 1 # 0-Composite
14 cobicistat
Indications Adverse Reactions/Side Effects
To increase blood levels of atazanivir and Noted for combination use with atazana-
darunavir (in combination with other an- vir.
tiretrovirals) in the treatment of HIV-1 in- EENT: ocular icterus. GI: jaundice, nau-
fection. sea. GU: acute renal failure (qwith teno-
fovir), Fanconi syndrome (qwith teno-
Action fovir).
By strongly inhibiting CYP3A enzymes, en-
hances systemic exposure to atazanivir Interactions
and darunavir. Therapeutic Effects: Due to the potential for interactions, regi-
Slowed progression of HIV infection and mens should be reviewed during any
decreased occurrence of sequelae. changes (starting or stopping medications
or altering dose). Because cobicistat is
Pharmacokinetics used in conjunction with darunavir, those
Absorption: Absorption follows oral ad- interactions are considered here.
ministration.
Distribution: Unknown. Drug-Drug: Concurrent use with alfu-
Protein Binding: 97 98%. zosinqrisk of potentially life threatening
reactions and is contraindicated.qblood
Metabolism and Excretion: Metabo-
levels/risk of potentially dangerous ad-
lized by CYP3A and to a small extent by
verse reactions with dronedarone; con-
CYP2D6; 86.2 eliminated in feces, 8.2% in
current use is contraindicated. Rifampin
urine.
maypblood levels/antiretroviral effective-
Half-life: 3 4 hr. ness of atazanavir or darunavir; concur-
TIME/ACTION PROFILE rent use in a regimen with cobistat is con-
traindicated.qblood levels and risk of
ROUTE ONSET PEAK DURATION serious toxicity from irinotecan when
PO unknown 3 hr 24 hr used in a regimen containing atazanavir
and cobicistat; concurrent use is contrain-
Contraindications/Precautions dicated (due to atazanivir decreasing me-
Contraindicated in: Concurrent use of tabolism of irinotecan).qrisk of serious
other drugs for whichqorpblood levels toxicity including peripheral vasospasm/
would be associated with serious/life- ischemia from dihydroergotamine, er-
threatening toxicity/adverse reactions or gotamine, and methylergonovine; con-
loss of effectiveness including alfuzosin, current use is contraindicated.qrisk of
dronedarone, rifampin, irinotecan, dihy- serious arrhythmias with cisapride and
droergotamine, ergotamine, methylergo- pimozide; concurrent use is contraindi-
novine, cisapride, St. Johns wort, lovasta- cated.qrisk of myopathy/rhabdomyolysis
with lovastatin and simvastatin; con-
tin, simvastatin, pimozide, nevirapine,
current use is contraindicated; other
sidenafil (when used for pulmonary hy- HMG-CoA reductase inhibitors should
pertension), indinavir, triazolam, and be initiated at the lowest recommended
midazolam (oral); Concurrent use with dose and carefully titrated. Concurrent use
other antiretrovirals whose blood levels/ with nevirapine mayplevels/effective-
effectiveness may bepor risk of resis- ness of atazanavir andqlevels/risk of ad-
tanceq; Lactation: HIV-infected women verse reactions from nevirapine; concur-
should not breast feed due to risk of viral rent use is contraindicated.qrisk of
transmission. adverse reactions including visual distur-
Use Cautiously in: Concurrent use of bances, hypotension, priapism and syn-
tenofovir (qrisk of acute renal failure or cope with sildenafil (contraindicated
Fanconi syndrome); OB: Use during preg- when used for pulmonary hypertension).
nancy only if potential benefits justify fetal Concurrent use with indinavir in a regi-
risks; Pedi: Safety and effectiveness not es- men containing atazanavirqrisk of hyper-
tablished. bilirubinemia and is contraindicated.
pg 15 Plate
# 2 # 0-Composite
cobicistat 15
qrisk of prolonged sedation/respiratory qbleeding risk with rivaroxaban; avoid
depression with oral midazolam and concurrent use. Effect on warfarin is not
triazolam; concurrent use is contraindi- know; monitor INR. Carbamazepine and
cated. Concurrent use of more than one oxcarbazepineplevels of cobicistat and
antiretroviral that requires another agent atazanavir; consider alternative anticon-
toqblood levels, such as two protease vulsants or antiretroviral. Mayqlevels of
inhibitors or a protease inhibitor in clonazepam and carbamazepine; care-
conjunction with elvitegravir mayp ful anticonvulsant monitoring recom-
antiretroviral effectiveness; concurrent mended. Mayqlevels/effects of tricyclic
use is not recommended. Concurrent use antidepressants and trazodone; care-
of darunavir concurrently with efavirenz, ful dosing of antidepressants recom-
nevirapine, or etravirine maypanti- mended (effect on SSRIs in unknown).
retroviral effectiveness andqrisk of resis- Concurrent use with itraconazole, keto-
tance; concurrent use is not recom- conazole, and voriconazole may result
mended. Concurrent use of atazanavir inqlevels of itraconazole and ketocona-
with etravirine or efavirenz (in treat- zole (effect on voriconazole is unknown)
ment-experienced patients) maypanti- andqlevels of atazanavir, cobicistat and
retroviral effectiveness andqrisk of darunavir; voriconazole use not recom-
resistance; concurrent use is not mended.qlevels/risk of adverse reactions
recommended. Concurrent use of daru- with colchicine; concurrent use in pa-
navir at a dose of 600 mg twice daily may tients with renal/hepatic impairment not
pantiretroviral effectiveness andqrisk of recommended, for others decrease
resistance; concurrent use at that dose is dose(for gout flare 0.6 mg followed by
not recommended. Concurrent use of 0.3 mg one hr later, may repeat no sooner
other protease inhibitors, including than 3 days, for prophylaxis of flare if
fosamprenavir, saquinavir, tipranavir dose was originally 0.6 mg twice daily, de-
maypantiretroviral effectiveness andq crease to 0.3 mg once daily, if original
risk of resistance; concurrent use is not regimen was 0.6 mg once daily, decrease
recommended. Should not be used con- to 0.3 mg every other day, treatment of
currently with other cobicistat-contain- familial Mediterranean fever daily
ing fixed-dose combinations or dose should not exceed 0.6 mg or 0.3 mg
ritonavir-containing regimens or twice daily).qlevels/effects/risk of ad-
fixed-dose combinations due to cumu- verse reaction including neutropenia and
lative effects on CYP3A.qlevels of mara- uveitis with rifabutin; lower rifabutin
viroc(when used concurrentlypmaravi- dose to 150 mg every other day.qlevels/
roc dose to 150 mg twice daily). effects of metoprolol, carvedilol, timo-
Anatacidspabsorption of atazanavir lol, or any other beta-blockers metab-
(separate doses by 2 hr).qlevel/risk of olized by CYP2D6; clinical monitoring
toxicity/adverse reactions with antiar- recommended.qlevels/effects of amlodi-
rhythmics including amiodarone, di- pine, diltiazem, felodipine, nifedi-
goxin, disopyrramide, flecainide, pine, verapamil, or any other calcium
mexiletine, propafenone, and quin- channel blocker metabolized by
dine; careful monitoring and titration is CYP3A; careful monitoring recom-
recommended. Clarithromycin, eryth- mended. Concurrent use of dexametha-
romycin, and telithromycin mayqlev- sone or other corticosteroids that in-
els of ataznavir, darunavir and cobicistat; duce CYP3A mayplevels/effectiveness
consider alternative anti-infectives.q andqrisk of resistance to azatanavir or
blood levels/risk of toxicity with dasati- darunavir (consider use of other cortico-
nib, nilotinib, vinblastine, and vin- steroids). Concurrent use of corticoste-
cristine; careful monitoring for toxicity roids that are metabolized by CYP3A
and dose adjustments recommended. May including inhaled fluticasone and bud-
pg 16 Plate
# 3 # 0-Composite
16 cobicistat
enosde may result inqsteroid effects. should not exceed 25 mg/48 hr, tadalafil
Concurrent use with bosentan may result for pulmonary hypertension-initiating
inqlevels/toxicity of bosentan andplev- tadalafil in patients receiving cobicistat
els of atazanaivr, darunavir and cobicistat; with atazanvir and darunavir for at least 7
dose alteration is required (initiating days 20 mg once daily initially, may be
bosentan in patients already receiving titrated to 40 mg once daily, initiating co-
cobicistat with atazanavir or darunavir bicistat with atazanavir or darunavir in pa-
for 10 days or more bosentan 62.5 mg tients receiving tadalafil discontinue
daily or every other day, depending on tol- tadalafil 24 hr prior to initiating cobicistat
erance; initiating cobicistat with ataza- with atazanavir or darunavir, after 7 days
navir or darunavir in patient already reinstitute tadalafil at 20 mg once daily,
receiving bosentan discontinue bos- may be increased to 40 mg once daily, for
entan for 10 days, resume bosentan at erectile dysfunction single dose should not
62.5 mg daily or every other day, depend- exceed 10 mg/72 hr; verdenafil for
ing on tolerance. H2-receptor antago- erectile dysfunction single dose should not
nists including famotidine may decrease exceed 2.5mg/72 hr. Proton-pump in-
levels/effectiveness andqrisk of resis- hibitors including omeprazoleplevels/
tance; administer simultaneously or at effectiveness andqrisk of resistance; in
least 10 hr after h2 receptor antagonist treatment nave patients, administer co-
(dose of h2 receptor antagonist should bicistat with atazanavir or darunavir at
not exceed famotidine 40 mg [or equiva- least 12 hr after proton-pump inhibitors,
lent] twice daily in treatment-nave pa- dose of proton-pump inhibitor should not
tients or famotidine 20 mg [or equivalent] exceed omeprazole 20 mg daily or equiva-
twice daily in treatment-experienced pa- lent, in treatment-experienced patients
tients; atazanavir dose should be in- concurrent use with proton-pump inhibi-
creased to 400 mg daily).qlevels/risk of tors is not recommended.qlevels/ effects
toxicity from immunosuppressants and risk of excess sedation/respiratory de-
metabolized by CYP3A including cyclo- pression from some sedative/hypnotics
sporine, everolimus, sirolimus, and metabolized by CYP3A including bus-
tacrolimus; therapeutic monitoring rec- pirone, diazepam, and parenteral
ommended.qlevels of salmeterol and midazolam; concurrent use with oral
mayqrisk of serious adverse cardiovascu- midazolam is contraindated, concurrent
lar events; concurrent use is not recom- with other sedative/hypnotics metab-
mended. Mayqlevels/risk of respiratory olized by CYP3A should be undertaken
depression with opioids including bu- with caution, dose reduction may be nec-
prenorphine, buprenorphine/nalox- essary.
one, fentanyl, and tramadol; carefully Drug-Natural Products: St. Johns
monitor opioid affects when cobicistat wort maypblood levels and antiretroviral
with atazanavir or darunavir is initiated, effectiveness of atazanavir or darunavir;
dose adjustment of opioid may be neces- concurrent use with a regimen including
sary. Mayqlevels/effects of neuroleptics cobistat is contraindicated.
that are metabolized by CYP3A or
CYP2D6 including perphenazine, ris- Route/Dosage
peridone, and thioridazine; dose de- with atazanavir
crease of neuroleptic may be necessary. PO (Adults (treatment-nave or expe-
Mayqlevels and risk of adverse cardio- rienced): 150 mg once daily with ataza-
vascular, ophthalmic and genitourinary ef- navir 300 mg once daily.
fects of PDE-5 inhibitors including
avanafil, sildenafil, tadalafil, and var- with darunavir
denafil; avanafil use is not recom- PO (Adults treatment-nave, treat-
mended, sildenafil use for pulmonary ment-experienced with no darunavir
hypertension is contraindicated, when resistance substitutions): 150 mg once
used for erectile dysfunction single dose daily with darunavir 800 mg once daily.
pg 17 Plate
# 4 # 0-Composite
dalbavancin 17
Availability without consulting health care profes-
Tablets: 150 mg. sional. Advise patient to read Patient
Information prior to starting therapy
NURSING IMPLICATIONS and with each Rx refill in case of
Assessment change. Also read Patient Information
Assess patient for change in severity of
for atazanavir or darunavir.
HIV symptoms and for symptoms of op- Instruct patient that cobicistat should
portunistic infections during therapy. not be shared with others.
Lab Test Considerations: Assess es-
timated creatinine clearance before fessional of all Rx or OTC medications,
starting therapy; cocicistat decreases vitamins, or herbal products being
estimated creatinine clearance by inhib- taken and consult health care profes-
iting tubular secretion of creatinine sional before taking any new medica-
without affecting actual renal function. tions, especially St. Johns Wort. Co-
Assess estimated creatinine clearance,
bicistat interacts with many other drugs.
urine glucose, and urine protein if co- Follow instructions for specific timing
bicistat administered with tenofovir. of or avoiding other medications.
Advise female patient to notify health
May causeqtotal bilirubin, creatine ki-
nase, serum amylase, ALT, AST, GGT, care professional if pregnancy is
urine glucose and urine RBC. planned or suspected or if breast feed-
ing.
Potential Nursing Diagnoses Emphasize the importance of regular
Risk for infection (Indications) follow-up exams and blood counts to
Deficient knowledge, related to medica- determine progress and monitor for
tion regimen (Patient/Family Teaching) side effects.
Implementation Evaluation/Desired Outcomes
PO: Administer with atazanavir or daru- Increased blood levels of atazanavir or
navir once daily with food. darunavir leading to slowed progres-
Administer antacids containing alumi- sion of HIV infection and decreased oc-
num or magnesium at least 2 hr before currence of sequelae.
or after cobicistat and atazanavir.
Administer H2 receptor antagonists at
same time or take cobicistat with ataza- dalbavancin
navir 10 hr after taking H2 receptor an- (dal-ba-van-sin )
tagonists. Dalvance
Administer cobicistat and atazanavir at
least 12 hr after administering proton Classification
pump inhibitors. Thera: anti-infectives
Patient/Family Teaching Pharm: lipoglycopeptides
Explain purpose of cobicistat to patient;
Pregnancy Category C
cobicistat does not treat HIV and must
be taken with antiretroviral medica-
tions. Instruct patient to take cobicistat Indications
as directed with food and with atazana- Treatment of skin/skin structure infections
vir or darunavir on a regular dosing due to susceptible bacteria.
schedule. Take missed doses as soon as Action
remembered if within 12 hr; if more Binds to bacterial cell wall resulting in cell
than 12 hr, skip dose and take next death. Therapeutic Effects: Bacteri-
dose as scheduled; do not double cidal action against susceptible bacteria
doses. Do not stop taking cobicistat with resolution of infection. Spectrum:
pg 18 Plate
# 1 # 0-Composite
18 dalbavancin
Active against Staphylococcus aureus (in- Availability
cluding methicillin-susceptible and resis- Lyophylized powder for intravenous
tant strains), Streptococcus agalactiae, injection (requires reconstitution
Streptococcus anginosus (including S. and further dilution): 500 mg single-
anginosus, S. intermidius and S. con- use vial.
stellatus) and Streptococcus pyogenes.
NURSING IMPLICATIONS
Pharmacokinetics
Absorption: IV administration results in Assessment
complete bioavailability. Assess for infection (vital signs; appear-
Distribution: Penetrates tissues and flu- ance of wound, sputum, urine, and
ids. stool; WBC) at beginning of and during
Metabolism and Excretion: 33% therapy.
eliminated unchanged in urine, 12% elim- Obtain specimens for culture and sensi-
inated as inactive metabolite, 20% ex- tivity prior to therapy. First dose may be
creted in feces. given before receiving results.
Half-life: 346 hr. Monitor bowel function. Diarrhea, ab-
dominal cramping, fever, and bloody
TIME/ACTION PROFILE (blood stools should be reported to health care
levels) professional promptly as a sign of pseu-
ROUTE ONSET PEAK DURATION domembranous colitis. May begin up to
2 mo following cessation of therapy.
IV unknown end of in- 1 wk
Monitor for infusion reactions (Red-
fusion
man syndrome flushing of upper
Contraindications/Precautions body, urticaria, pruritus, rash). May re-
Contraindicated in: Hypersensitivity. solve with stopping or slowing infusion.
Use Cautiously in: Renal impairment Lab Test Considerations: Monitor
(dose adjustment required for CCr 30 hepatic function tests. May causeqALT,
mL/min; Moderate to severe hepatic im- AST, and bilirubin.
pairment; Geri: Consider age-related de- Potential Nursing Diagnoses
crease in renal function; OB: Use during Risk for infection (Indications)
pregnancy only if potential benefit justifies Diarrhea (Adverse Reactions)
potential risk to the fetus; Lactation: Use Implementation
cautiously if breast feeding; Pedi: Safe and
effective use in children has not been es- IV Administration
tablished. Intermittent Infusion: Reconstitute
Adverse Reactions/Side Effects with 25 mL of Sterile water in each 500
mg vial. Alternate gentle swirling and in-
CNS: headache. GI: DIARRHEA INCLUDING verting to avoid foaming, until com-
CLOSTRIDIUM DIFFICILE, nausea,qALT.
pletely dissolved. Do not shake. Recon-
Derm: pruritus, rash. Misc: hypersensi- stituted vial contains a clear colorless to
tivity reactions including ANAPHYLAXIS, in- yellow solution. Do not administer solu-
fusion reactions including Red-Man Syn- tions that are discolored or contain par-
drome. ticulate matter. Transfer reconstituted
Interactions solution into D5W. Concentration: 1
Drug-Drug: None noted. mg/mL to 5 mg/mL. Discard unused so-
Route/Dosage lution. May be refrigerated or kept at
IV (Adults): 1000 mg followed one wk room temperature; do not freeze. Infuse
later by 500 mg. within 48 hr of reconstitution. Do not
administer solutions containing particu-
Renal Impairment late matter. Rate: Infuse over 30 min.
IV (Adults): CCr 30 mL/min 750 Y-Site Incompatibility: Do not infuse
mg followed one wk later by 375 mg. with other medications or electrolytes.
pg 19 Plate
# 19 # 0-Composite
droxidopa 19
Saline solutions may cause precipita- Action
tion. Flush line before and after infusion Acts as a synthetic precursor that is con-
with D5W. verted by dopa decarboxylase to norepi-
Patient/Family Teaching nephrine which produces peripheral arte-
Instruct patient to notify health care rial and venous vasocontriction. Result is
professional if signs and symptoms of increased blood pressure. Therapeutic
hypersensitivity reactions (rash, hives, Effects: Increased blood pressure with
dyspnea, facial swelling) occur. decreased symptoms of orthostatic dizzi-
Instruct patient to notify health care ness.
professional immediately if diarrhea, Pharmacokinetics
abdominal cramping, fever, or bloody Absorption: Systemic absorption fol-
stools occur and not to treat with antidi- lows oral administration.
arrheals without consulting health care Distribution: Crosses the blood-brain
professionals. barrier.
Advise patient to notify health care pro- Metabolism and Excretion: Metabo-
fessional of all Rx or OTC medications, lized via catecholamine pathway; metabo-
vitamins, or herbal products being lites other than norepinephrine do not
taken and to consult with health care contribute to activity. 75% excreted by
professional before taking other medi- kidneys as parent drug and metabolites.
cations. Half-life: 2.5 hr.
Advise female patients to use effective
contraception during therapy and to no- TIME/ACTION PROFILE (q blood
tify health care professional if preg- pressure)
nancy is suspected or if breast feeding.
Instruct the patient to notify health care
professional if symptoms do not im- PO unknown 14 hr unknown
prove.
Evaluation/Desired Outcomes Contraindicated in: Hypersensitivity to
Resolution of the signs and symptoms of droxidopa or tartrazine (FDC No. 5
infection. Length of time for complete [cross sensitivity between aspirin and
resolution depends on the organism FDC No. 5 may occur); CCr 30 mL/
and site of infection. min; Lactation: Discontinue droxidopa or
discontinue breast feeding.
droxidopa (drox-i-doe-pa) Use Cautiously in: Hypertension
Northera (should be controlled prior to treatment);
Mild to moderate renal impairment (q
Classification risk of adverse reactions); History of car-
Thera: Antihypotensives diovascular disease (may exacerbate hy-
Pharm: adrenergics pertension, ischemic heart disease, ar-
rhythmias or CHF); Geri: Elderly patients
may be more sensitive to drug effects; OB:
Indications Safe use during pregnancy has not been
Treatment of orthostatic dizziness, light-
established; Pedi: Safe and effective use in
headedness or feeling of impending black-
children has not been established.
out associated with symptomatic neuro-
genic orthostatic hypotension due to Adverse Reactions/Side Effects
primary autonomic failure (Parkinsons CNS: confusion, dizziness, fatigue, head-
disease, multiple system atrophy), dopa- ache. CV: ARRHYTHMIAS, CHF, MYOCARDIAL
mine beta-hydroxylase deficiency or non- ISCHEMIA, supine hypertension. GI: nau-
diabetic autonomic neuropathy. sea. Misc: hyperpyrexia.
pg 20 Plate
# 20 # 0-Composite
20 dulaglutide
Interactions sleep. Swallow capsule whole; do not
Drug-Drug:qrisk of supine hyperten- open, crush or chew.
sion with other agents thatqblood May be administered without regard to
pressure including ephedrine, norepi- food, but should be consistent each
nephrine, midodrine, pseudoephed- dose.
rine, and triptans. Concurrent use of Patient/Family Teaching
DOPA decarboxylase inhibitors may Instruct patient to take droxidopa as di-
require dose adjustments. rected. If dose is missed, omit and take
Route/Dosage next dose at scheduled time; do not
PO (Adults): 100 mg three times daily, double doses.
may beqby 100 mg three times daily up Advise patient to raise head of bed when
to 600 mg three times daily (last dose resting or sleeping.
should be given at least 3 hr prior to bed- Instruct patient how to take blood pres-
time). sure and manage elevations.
Availability care professional if pregnancy is
Capsules (contain tartrazine): 100 planned or suspected or if breast feed-
mg, 200 mg, 300 mg. ing.
NURSING IMPLICATIONS Evaluation/Desired Outcomes
Increased blood pressure with de-
Assessment creased symptoms of orthostatic dizzi-
Monitor blood pressure prior to and
ness.
during therapy; more frequently during
dose increases. Measure blood pres-
sure in supine position and while head dulaglutide
of bed is elevated; lessens risks of su- (doo-la-gloo-tide )
pine hypertension. If supine hyperten- Trulicity
sion cannot be managed by elevating
head of bed, reduce or discontinue Classification
droxidopa. Poorly managed supine hy- Thera: antidiabetics
pertension may increase risk for car- Pharm: glucagon-like pep-
diovascular events.
Monitor for symptom complex resem-
tide-1 (GLP-1) receptor
bling neuroleptic malignant syndrome agonists
(fever, muscle rigidity, involuntary Pregnancy Category C
movements, altered consciousness,
mental status changes) when dose is
changed or when concomitant levodopa Indications
is abruptly reduced or discontinued, es- Adjunct treatment to diet and exercise in
the management of adults with type 2 dia-
pecially if patient is receiving neurolep-
betes mellitus; not recommended as first
tics. Syndrome is rare but potentially fa-
line therapy, as a substitute for insulin, in
tal.
patients with type 1 diabetes, or for keto-
Potential Nursing Diagnoses acidosis.
Deficient knowledge, related to disease Action
process and medication regimen (Patient/ Acts as an acylated human Glucagon-Like
Family Teaching) Peptide-1 (GLP-1, an incretin) receptor
Implementation agonist; increases intracellular cyclic AMP
PO: Administer upon arising in the (cAMP) leading to insulin release when
morning, midday, and in late afternoon glucose is elevated, which then subsides
at least 3 hr prior to bedtime to reduce as blood glucose decreases toward eugly-
risk of supine hypertension during cemia. Also decreases glucagon secretion
pg 21 Plate
# 1 # 0-Composite
dulaglutide 21
and delays gastric emptying. Therapeu- Route/Dosage
tic Effects: Improved glycemic control. Subcut (Adults): 0.75 mg once weekly;
Pharmacokinetics may be increased to 1.5 mg once weekly
Absorption: 0.75 mg dose 65% ab- to obtain glycemic control.
sorbed following subcutaneous adminis- Availability
tration; 1.5 mg dose 47% absorbed fol- Solution for subcutaneous injection:
lowing subcutaneous administration. 0.75 mg/0.5 mL single-dose pen, 0.75 mg/
Distribution: Unknown. 0.5 mL single-dose prefilled syringe, 1.5
Metabolism and Excretion: Degraded mg/0.5 mL single use pen, 1.5 mg/0.5 mL
by protein catabolic processes. single-dose prefilled syringe.
Half-life: 5 days.
TIME/ACTION PROFILE (p in HbA1c)
Assessment
ROUTE ONSET PEAK DURATION Observe patient taking concurrent insu-
subcut within 4 wk 13 wk unknown lin for signs and symptoms of hypogly-
cemic reactions (sweating, hunger,
Contraindications/Precautions weakness, dizziness, tremor, tachycar-
Contraindicated in: Hypersensitivity; dia, anxiety, headache, blurred vision,
Personal or family history of medullary slurred speech, irritability).
thyroid carcinoma (MTC)/multiple endo- If thyroid nodules or elevated serum
crine neoplasia syndrome type 2 (MEN 2); calcitonin are noted, patient should be
Type 1 diabetes; Diabetic ketoacidosis; Se- referred to an endocrinologist.
vere gastrointestinal disease (including se- Monitor for pancreatitis (persistent se-
vere gastroparesis); Lactation: Avoid use; vere abdominal pain, sometimes radiat-
Pedi: Not recommended. ing to the back, with or without vomit-
Use Cautiously in: History of pancreati- ing). If pancreatitis is suspected,
tis; History of angioedema to another GLP- discontinue dulaglutide; if confirmed,
1 receptor agonist; Hepatic/renal impair- do not restart dulaglutide.
ment; OB: Use only if potential benefit Lab Test Considerations: Monitor
justifies potential risk to fetus. serum HbA1c periodically during ther-
Adverse Reactions/Side Effects apy to evaluate effectiveness.
CNS: fatigue. Derm: pruritis, rash. Mayqlipase and pancreatic amylase.
Endo: THYROID C-CELL TUMORS. GI: PAN- Potential Nursing Diagnoses
CREATITIS, diarrhea, nausea, abdominal Imbalanced nutrition: more than body re-
pain,pappetite, dyspepsia, vomiting, con- quirements (Indications)
stipation. GU: acute renal failure. Local: Noncompliance (Patient/Family Teaching)
hypersensitivity reactions including ANA-
PHYLAXIS AND ANGIOEDEMA, injection site
Implementation
Patients stabilized on a diabetic regimen
reactions.
who are exposed to stress, fever,
Interactions trauma, infection, or surgery may re-
Drug-Drug: Concurrent use with insu- quire administration of insulin.
lin or agents that increase insulin se- Subcut: Administer once daily at any
cretion including sulfonylureas mayq time of the day, without regard to food.
the risk of serious hypoglycemia, use cau- Day of week may be changed as long as
tiously and consider dosepof insulin or at least 72 hr before next dose. Inject
agents increasing insulin secretion. May into abdomen, thigh, or upper arm. So-
alter absorption of concomitantly adminis- lution should be clear and colorless; do
tered oral medications due to delayed not administer solutions that are discol-
gastric emptying. ored or contain particulate matter.
pg 22 Plate
# 22 # 0-Composite
22 edoxaban
Patient/Family Teaching Advise patient to notify discontinue du-
Instruct patient on use of pen and to laglutide and health care professional
take dulaglutide as directed. Follow immediately if signs of pancreatitis
manufacturers instructions for pen use. (nausea, vomiting, abdominal pain) oc-
Pen should never be shared between cur.
patients, even if needle is changed. Inform patient of risk of benign and
Store pen in refrigerator; do not freeze. malignant thyroid C-cell tumors. Advise
After initial use, pen may be stored at patient to notify health care professional
room temperature up to 14 days. Advise if symptoms of thyroid tumors (lump in
patient to read the Patient Medication neck, hoarseness, trouble swallowing,
Guide before starting dulaglutide and shortness of breath) or if signs of aller-
with each Rx refill in case of changes. gic reaction (swelling of face, lips,
Take missed dose as soon as remem- tongue, or throat; fainting or feeling
bered as long as 3 days (72 hr) until dizzy; very rapid heartbeat; problems
next scheduled dose. If less than 3 days breathing or swallowing; severe rash or
until next scheduled dose, skip and take itching) occur.
Advise patient to inform health care
next scheduled dose.
Inform patient that nausea is the most professional of medication regimen be-
fore treatment or surgery.
common side effect, but usually de-
Insulin is the preferred method of con-
creases over time. trolling blood glucose during preg-
Advise patient taking insulin and dulag- nancy. Counsel female patients to notify
lutide to never mix insulin and dulaglu- health care professional if pregnancy is
tide together . Give as 2 separate injec- planned or suspected or if breast feed-
tions. Both injections may be given in ing.
the same body area, but should not be Advise patient to carry a form of sugar
given right next to each other. (sugar packets, candy) and identifica-
Explain to patient that this medication tion describing disease process and
controls hyperglycemia but does not medication regimen at all times.
cure diabetes. Therapy is long-term. Emphasize the importance of routine
Review signs of hypoglycemia and hy- follow-up exams.
perglycemia with patient. If hypoglyce-
mia occurs, advise patient to take a Evaluation/Desired Outcomes
Improved glycemic control.
glass of orange juice or 2 3 tsp of
sugar, honey, or corn syrup dissolved in
water and notify health care profes- edoxaban (e-dox-a-ban)
sional. Savaysa
Encourage patient to follow prescribed
diet, medication, and exercise regimen Classification
to prevent hypoglycemic or hyperglyce- Thera: anticoagulants
mic episodes. Pharm: factor Xa inhibi-
Instruct patient in proper testing of se- tors
rum glucose and ketones. These tests
should be closely monitored during pe- Pregnancy Category C
riods of stress or illness, and health
care professional should be notified if Indications
significant changes occur. Reduction of stroke/systemic embolization
Advise patient to notify health care pro- (SE) risk associated with nonvalvular
fessional of all Rx or OTC medications, atrial fibrillation (NVAF).
vitamins, or herbal products being Action
taken and consult health care profes- Selective inhibitor of factor Xa. Does not
sional before taking any new medica- inhibit platelet aggregation directly, but
tions. does inhibit thrombin-induced platelet ag-
pg 23 Plate
# 23 # 0-Composite
edoxaban 23
gregation. Decreases thrombin generation Interactions
and thrombus development. Therapeu- Drug-Drug: Concurrent use of other an-
tic Effects: Decreased thrombotic events ticoagulants, antifibrotics, antiplate-
associated with atrial fibrillation including let agents, aspirin, fibrinolytics,
stroke and systemic embolization. Treat- NSAIDs or SSRIs mayqrisk of bleeding.
ment of deep vein thrombosis (DVT) and Rifampin maypblood levels and effective-
plumonary embolism (PE) after 5 10 ness and is contraindicated. Concurrent
days of parenteral anticoagulant. use of P-gp inhibitors including azith-
Pharmacokinetics romycin, clarithromcyin, erythromy-
Absorption: 62% absorbed following cin, itraconazole (oral), ketoconazole
oral administration. oral), quinidine, or verapamilqblood
Distribution: Unknown. levels and the risk of bleeding (lower dose
Metabolism and Excretion: Minimal required).
metabolism, one metabolite is pharmaco- Route/Dosage
logically active. Excreted mostly un-
changed in urine. Treatment of NVAF
Half-life: 10 14 hr. PO (Adults): 60 mg once daily.
TIME/ACTION PROFILE Renal Impairment
(anticoagulant effect) PO (Adults): CCr 15 50 mL/min 30
mg once daily.
Treatment of DVT/PE
PO unknown 12 hr 24 hr
PO (Adults 60 kg): 60 mg once daily.
Contraindications/Precautions PO (Adults 60 kg or certain concur-
Contraindicated in: Active bleeding; rent P-gp inhibitors): 30 mg once
CCr 95 mL/min (peffectiveness); Con- daily.
current use of other anticoagulants or rif-
Renal Impairment
ampin; Presence of mechanical heart
PO (Adults CCr 15 50 ml/min ): 30
valves or severe mitral stenosis; Moderate
mg once daily.
to severe hepatic impairment; Lactation:
Discontinue edoxaban or discontinue Availability
breast feeding. Tablets: 15 mg, 30 mg, 60 mg.
Use Cautiously in: Elective/planned in-
vasive/surgical procudures (discontinue NURSING IMPLICATIONS
at least 24 hr prior toprisk of bleeding); Assessment
Premature discontinuation (qrisk of is- Monitor for bleeding. Discontinue
chemic events); Neuroaxial anesthesia/ edoxaban if active pathological bleeding
spinal puncture (qrisk of spinal/epidural occurs. Concomitant drugs (aspirin,
hematoma and potential paralysis); Renal other antiplatelet agents, other anti-
impairment (dose reduction required for thrombotic agents, fibrinolytic therapy,
CCr 15 50 mL/min); Deteriorating or im- chronic use of NSAIDs) may increase
proving renal function (may require dose risk of bleeding. Anticoagulant effects of
change); Body weight 60 kg (requires edoxaban persist for about 24 hr after
lower dose); OB: Use during pregnancy last dose; there is no established way to
only if potential benefit outweighs poten- reverse anticoagulant effects. Anticoag-
tial risk to fetus; Pedi: Safe and effective ulant effects cannot be reliably moni-
use in children has not been established. tored with standard laboratory tests. No
Adverse Reactions/Side Effects reversal agent is available; protamine
GI: abnormal liver function tests. Hemat: sulfate, vitamin K, and tranexamic acid
BLEEDING, anemia. do not reverse anticoagulant activity.
pg 24 Plate
# 1 # 0-Composite
24 edoxaban
Hemodialysis does not significantly con- K antagonists to edoxaban, discon-
tribute to edoxaban clearance. tinue current oral anticoagulant and
Monitor frequently for signs and symp- start edoxaban at time of next sched-
toms of neurological impairment uled dose of other oral anticoagulant. If
(numbness or weakness of legs, bowel, transitioning from low molecular
or bladder dysfunction, back pain, tin- weight heparin (LMWH) to edoxaban,
gling, muscle weakness); if noted, ur- discontinue LMWH and start edoxaban
gent treatment is required. Intrathecal at time of next scheduled administration
or epidural catheters should not be re- of LMWH. If transitioning from un-
moved earlier than 12 hr after last dose fractionated heparin to edoxaban,
of edoxaban. Next dose of edoxaban discontinue infusion and start edoxaban
should not be given less than 2 hr after 4 hr later.
removal of catheter. If transitioning from edoxaban to
Lab Test Considerations: Assess warfarin, Oral Option: For patients tak-
creatinine clearance (CrCl) using Cock- ing 60 mg of edoxaban, reduce dose to
croft-Gault equation (Cockcroft-Gault 30 mg and begin warfarin concomi-
CrCl (140-age) x (weight in kg) x tantly. For patients taking 30 mg edoxa-
(0.85 if female)/(72 x creatinine in mg/ ban, reduce dose to 15 mg and begin
dL) before starting therapy. warfarin concomitantly. Measure INR at
Potential Nursing Diagnoses least weekly and just prior to daily dose
Risk for injury (Adverse Reactions) of edoxaban to minimize influence of
edoxaban on INR measurements. Once
Implementation stable INR 2.0 achieved, discontinue
Discontinue edoxaban at least 24 hr edoxaban and continue warfarin. Par-
prior to invasive or surgical proce- enteral Option: Discontinue edoxaban
dures; may increase risk of bleeding. and administer a parenteral anticoagu-
Edoxaban may be restarted as soon as lant and warfarin at time of next sched-
adequate hemostasis is established; uled edoxaban dose. Once stable INR
time to onset of pharmacodynamic ef- 2.0 achieved, discontinue parenteral
fect is 1 2 hr. anticoagulant and continue warfarin. If
PO: Nonvalvular Atrial Fibrillation: transitioning from edoxaban to non-
Administer 60 mg once daily without re- Vitamin-K Dependant Oral anticoag-
gard to food. Do not use in patients with ulant, discontinue edoxaban and start
CrCl 95 mL/min. If CrCl 15 to 50 mL/ other oral anticoagulant at time of next
min, decrease dose to 30 mg once dose of edoxaban. If transitioning
daily. from edoxaban to parenteral antico-
Deep Vein Thrombosis and Pulmo- agulant, discontinue edoxaban and
nary Embolism: Administer 60 mg start parenteral anticoagulant at time of
once daily without regard to food fol- next dose of edoxaban.
lowing 5 to 10 days of parenteral anti-
coagulant therapy. If CrCl 15 to 50 mL/ Patient/Family Teaching
min, patient weighs 60 kg, or patient Instruct patient to take edoxaban as di-
taking concurrent verapamil, quinidine, rected. Take missed doses as soon as
azithromycin, clarithromycin, erythro- remembered on same day. Return to
mycin, oral itraconazole or oral keto- regular schedule next day. Do not dou-
conazole, decrease dose to 30 mg once ble doses in one day. Do not discon-
daily. tinue without consulting health care
If transitioning from warafarin or professional; stopping may increase
other vitamin K antagonists to edoxa- risk of stroke.
ban, discontinue warfarin and start Caution patient that they may bleed
edoxaban when INR 2.5. If transi- more easily, longer, or bruise more
tioning from oral anticoagulants easily during therapy. Advise patient to
other than warfarin or other Vitamin notify health care professional immedi-
pg 25 Plate
# 25 # 0-Composite
efinaconazole 25
ately if bleeding or a fall, especially with Metabolism and Excretion: Un-
head injury, occurs. known.
Advise patient to notify health care pro- Half-life: 29.9 hr.
fessional of all Rx or OTC medications,
vitamins, or herbal products being TIME/ACTION PROFILE
taken and to consult with health care ROUTE ONSET PEAK DURATION
professional before taking other medi- Topical unknown unknown unknown
cations, especially other aspirin or
NSAIDs. Prolonged treament is necessary due to need
Advise patient to notify health care pro- for treatment throughout growth of new toenails.
fessional of therapy before surgery, Contraindications/Precautions
medical, or dental procedures are Contraindicated in: None noted.
scheduled. Use Cautiously in: Geri: Elderly pa-
Advise female patient to notify health tients may be more sensitive to drug ef-
care professional if pregnancy is fects; OB: Use during pregnancy only if po-
planned or suspected. Avoid breast tential maternal benefit justifies potential
feeding during therapy. risk to fetus; Lactation: Use cautiously if
Evaluation/Desired Outcomes breast feeding; Pedi: Safe and effective use
Decreased thrombotic events (stroke in children has not been established.
and systemic embolization) associated Adverse Reactions/Side Effects
with atrial fibrillation. Local: application site dermatitis, appli-
Treatment of deep vein thrombosis cation site pain, application site vesicles,
(DVT) and pulmonary embolism (PE). ingrown toenail.
Interactions
enaconazole Drug-Drug: None noted.
(eff-in-a-kon-a-zole) Route/Dosage
Jublia Topical (Adults): Apply to affected toe-
nails once daily for 48 wk.
Classification Availability
Thera: antifungals Solution: 10% in 4 and 8 mL bottles
Pharm: triazoles (with integrated flow-through applicator
brush).
Indications
Topical treatment of onychomycosis of the Assessment
toenail. Inspect involved areas of skin before
and frequently during therapy. In-
Action creased skin irritation may indicate
Inhibits synthesis of ergosterol, a compo- need to discontinue medication.
nent of fungal cell membranes. Thera- Potential Nursing Diagnoses
peutic Effects: Resolution of toenail Risk for impaired skin integrity (Indica-
fungus. Spectrum: Active against Tricy- tions)
hophyton rubrum and Trychophyton Risk for infection (Indications)
mentagrophytes.
Implementation
Pharmacokinetics Topical: Apply to affected clean, dry
Absorption: Minimal systemic absorp- toenails once daily for 48 wks with inte-
tion follows application to toenails. grated flow-through brush applicator.
Distribution: Unknown. Ensure toenail, toenail folds, toenail
pg 26 Plate
# 26 # 0-Composite
26 eliglustat
bed, hyponychium, and undersurface of Action
toenail plate are completely covered. Acts as a specific inhibitor of glucosylcer-
Solution is clear, colorless to pale yel- amide synthase, thereby reducing the sub-
low. strate that accumulates in Gaucher disease
Patient/Family Teaching type 1. Therapeutic Effects: Improve-
Instruct patient to apply efinaconazole
ment in symptoms of Gauchers disease
as directed for full course of therapy, (anemia, thrombocytopenia, bone dis-
even if feeling better. Emphasize the im- ease, splenomegaly, and hepatomegaly).
portance of topical use only, not for Pharmacokinetics
oral, ophthalmic or intravaginal use. Absorption: EMs 5% absorbed fol-
Advise patient to wait at least 10 min af- lowing oral administration (due to exten-
ter showering, bathing, or washing be- sive first-pass metabolism).
fore applying. Efinaconazole is flamma- Distribution: Distributes mainly into
ble; avoid use near heat or open flame. plasma.
Advise patient to report increased skin Metabolism and Excretion: Exten-
irritation (redness, itching, swelling) to sively metabolized, primarily by the
health care professional. CYP2D6 enzyme system, with some metab-
Caution patient to avoid pedicures, nail olism by CYP3A4; 41.8% excreted in urine
polish, and cosmetic nail procedures and 51.4% in feces mostly as metabolites.
during therapy. Half-life: EMs 6.5 hr; PMs 8.9 hr.
professional of all Rx or OTC medica- TIME/ACTION PROFILE (blood
tions, vitamins, or herbal products be- levels)
ing taken and to consult with health
care professional before taking other
medications. PO unknown 1.52 hr 1224 hr
Advise female patient to notify health (EMs),
3 hr
care professional if pregnancy is (PMs)
planned or suspected or if breast feed-
ing. Contraindications/Precautions
Evaluation/Desired Outcomes Contraindicated in: CYP2D6 ultra-
Resolution of toenail fungus. rapid metabolizers (may not achieve effec-
tive concentrations); Concurrent use of
strong or moderate CYP2D6 inhibitors in
eliglustat (e-lig-lu-stat) patients who are CYP2D6 EMs or IMs
Cerdelga (risk of adverse cardiac events); Concur-
rent use of strong CYP3A inhibitors in pa-
Classification tients who are CYP2D6 PMs or IMs (risk
Thera: orphan drugs of adverse cardiac events); History of car-
Pharm: glucosylceramide diac disease, Long QT syndrome, or con-
synthase inhibitors current use of Class IA or Class III anti-ar-
rhythmics; Concurrent ingestion of
Pregnancy Category C grapefruit/grapefruit juice; Moderate or
severe renal impairment; Hepatic impair-
Indications ment; Lactation: Discontinue eliglustat or
Long term treatment of adults with discontinue breast feeding.
Gaucher disease type 1 who have been Use Cautiously in: CYP2D6 indetermi-
tested to be extensive metabolizers (EMs), nate metabolizers (dose not known); OB:
intermediate metabolizers (IMs) or poor Use only if potential maternal benefit justi-
metabolizers (PMs) of the CYP2D6 en- fies risk to fetus; Pedi: Safe and effective
zyme system. use in children has not been established.
pg 27 Plate
# 27 # 0-Composite
eliglustat 27
Adverse Reactions/Side Effects tineqrisk of potentially serious cardiac
CNS: fatigue, headache, dizziness. CV: events (once daily dosing recommended).
palpitations. GI: diarrhea, flatulence, nau- Concurrent use of moderate inhibitors
sea, oropharyngeal pain, upper abdomi- of CYP2D6 including terbinafineqrisk
nal pain, constipation, reflux. Derm: of potentially serious cardiac events (once
rash. MS: arthralgia, back pain, extremity daily dose recommended). Concurrent
pain. use of strong inhibitors of CYP3A in-
cluding ketoconazoleqrisk of poten-
Interactions tially serious cardiac events (once daily
General. dose recommended). Concurrent use of
Drug-Drug: Concurrent use of strong moderate inhibitors of CYP3A includ-
CYP3A inducers including carbamaze- ing fluconazoleqrisk of potentially seri-
pine, phenobarbital, phenytoin, and ous cardiac events (once daily dose rec-
rifampin maypblood levels and effec- ommended).
tiveness (concurrent use not recom- Interactions
mended). Mayqblood levels and effects/
risk of toxicity with drugs that are P-gp For intermediate metabolizers (IMs).
substrates including digoxin (pdigoxin Drug-Drug: Concurrent use of strong
dose by 30% and monitor digoxin levels), or moderate CYP2D6 inhibitors plus
colchicine, dabigatran, and phenytoin strong or moderate CYP3A inhibitors
(monitor drug levels, consider dose re- with eliglustatqrisk of potentially serious
duction/titration). Mayqblood levels and cardiac events (concurrent use contrain-
effects/risk of toxicity with drugs that are dicated). Concurrent use of strong in-
CYP2D6 substrates including meto- hibitors of CYP2D6 including paroxe-
prolol, tricyclic antidepressants, and tineqrisk of potentially serious cardiac
phenothiazines(monitor drug levels, events (once daily dose recommended).
consider dose reduction/titration). Con- Concurrent use of moderate inhibitors
current use of Class IA anti-arrhythmics of CYP2D6 including terbinafineqrisk
(including procainamide and quini- of potentially serious cardiac events (once
dine) or Class III anti-arrhythmics (in- daily dose recommended). Concurrent
cluding amiodarone and sotalol)qrisk use of strong inhibitors of CYP3A in-
of potentially serious adverse cardiac cluding ketoconazoleqrisk of poten-
events (concurrent use not recom- tially serious cardiac events (concurrent
mended). use contraindicated). Concurrent use of
Drug-Natural Products: St. Johns moderate inhibitors of CYP3A includ-
wortpblood levels and maypeffective- ing fluconazoleqrisk of potentially seri-
ness (concurrent use not recommended). ous cardiac events (concurrent use not
Drug-Food: Grapefruit/grapefruit recommended).
juiceqrisk of potentially serious adverse Interactions
cardiac events (concurrent ingestion con-
traindicated). For poor metabolizers (PMs).
Drug-Drug: Concurrent use of strong
Interactions inhibitors of CYP3A including keto-
For extensive metabolizers (EMs). conazoleqrisk of potentially serious
Drug-Drug: Concurrent use of strong cardiac events (concurrent use contrain-
or moderate CYP2D6 inhibitors plus dicated). Concurrent use of moderate
strong or moderate CYP3A inhibitors inhibitors of CYP3A including flucona-
with eliglustatqrisk of potentially serious zoleqrisk of potentially serious cardiac
cardiac events (concurrent use contrain- events (concurrent use not recom-
dicated). Concurrent use of strong in- mended). Concurrent use of weak inhib-
hibitors of CYP2D6 including paroxe- itors of CYP3A including ranitidineq
pg 28 Plate
# 28 # 0-Composite
28 elosulfase alfa
risk of potentially serious cardiac events Advise patient to notify health care pro-
(concurrent use not recommended). fessional of all Rx or OTC medications,
Route/Dosage vitamins, or herbal products being
PO (Adults): CYP2D6 EMs or IMs 84 taken and to consult with health care
mg twice daily; CYP2D6 PMs 84 mg professional before taking other medi-
once daily; CYP2D6 EMs or IMs taking cations, especially St. Johns Wort.
strong or moderate CYP2D6 inhibitors Advise female patient to notify health
or CYP2D6 EMs taking strong or moder- care professional if pregnancy is
ate CYP3A inhibitors 84 mg once planned or suspected or if breast feed-
daily. ing.
Emphasize the importance of follow-up
Availability examinations and lab tests.
Capsules: 84 mg.
Evaluation/Desired Outcomes
NURSING IMPLICATIONS Improvement in symptoms of Gauchers
disease (anemia, thrombocytopenia,
Assessment bone disease, splenomegaly, and hepa-
Monitor for an improvement in symp- tomegaly).
toms including hepatomegaly, spleno-
megaly, anemia, thrombocytopenia,
bone demineralization, and increased elosulfase alfa
appetite and energy level periodically (el-oh-sul-fase al-fa)
duting therapy. Assess liver and spleen Vimizim
size every 6 mo to determine effective-
ness of therapy. Classification
Potential Nursing Diagnoses Thera: orphan drugs
Fatigue (Indications) Pharm: enzymes
Risk for injury (Indications)
Implementation
Administer 24 hr after last dose of imig- Indications
lucerase, taliglucerase, or velaglucer- Treatment of patients with Mucopolysac-
ase. charidosis type IVA (MPS IVA, Morquio A
PO: Administer without regard to food, Syndrome).
preferably with water. Swallow capsules
whole; do not open, crush or chew. Action
Consists of an enzyme produced by re-
Patient/Family Teaching combinant DNA technology that hydrolyzes
Instruct patient to take eliglustat as di- sulfate from galactose-6 sulfate or N-ace-
rected. Omit missed doses and take tyl-galactosamine-6 sulfate. Lack of this
next scheduled dose; do not double enzyme in Mucoplysaccharidosis results in
doses. Advise patient to read Medica- intracellular accumulation of glycosami-
tion Guide before starting therapy and noglycans (GAG) producing widespread
with each Rx refill in case of changes. cellular, tissue and organ dysfunction.
Advise patient to avoid grapefruit and
grapefruit juice during therapy.
Therapeutic Effects: Decreased accu-
Inform patient of the purpose of this
mulation of GAG, decreased end organ
medication and the importance of treat- dysfunction and improved musculoskele-
ment at least every 4 wk. Eliglustst helps tal performance MPS IVA.
control the symptoms but does not cure Pharmacokinetics
Gauchers disease. Lifelong therapy may Absorption: IV administration results in
be required. complete bioavailability.
Advise patient to notify health care pro- Distribution: Taken up by cells.
fessional if palpitations, fainting, or diz- Metabolism and Excretion: Un-
ziness occur. known.
pg 29 Plate
# 1 # 0-Composite
elosulfase alfa 29
Half-life: Initially 7 min; after pro- retching, vomiting). Discontinue infu-
longed treatment 35.9 min (due to sion and manage symptomatically. May
neutralizing antibodies). occur 30 min to 3 hr after start of infu-
sion and as late as 47th infusion.
TIME/ACTION PROFILE (blood Evaluate airway patency and risk of
levels) sleep apnea. Provide supplemental oxy-
ROUTE ONSET PEAK DURATION gen or continuous positive airway pres-
IV unknown end of in- unknown
sure (CPAP) during sleep and infusion
fusion in case of acute reaction or extreme
sleepiness induced by antihistamine.
Improvement in musculoskeletal function may
take wk-mos. Potential Nursing Diagnoses
Deficient knowledge, related to medica-
Contraindications/Precautions tion regimen (Indications)
Contraindicated in: None noted.
Use Cautiously in: Concurrent acute Implementation
Pre-treat with antihistamines, with or
febrile/respiratory illness (qrisk of life
without antipyretics, 30 60 min prior
threatening complications of hypersensi-
to start of infusion.
tivity reaction); Sleep apnea (supportive
Intermittent Infusion: Determine
measures should be available during infu-
number of vials required. Diluent: Di-
sion); OB: Use during pregnancy only if
lute with 0.9% NaCl to a final volume of
potential benefit justifies potential risk to
100 mL for patients weighing less than
fetus; Consider maternal need for elosul-
25 kg or 250 mL for patients weighing
fase alfa and potential adverse effects to
25 kg or more. Solution is clear to
infant; Pedi: Safe and effective use in chil-
slightly opalescent and colorless to pale
dren 5 yr has not been established.
yellow; do not administer solutions that
Adverse Reactions/Side Effects are discolored or contain particulate
CNS: fatigue, headache. GI: abdominal matter. Gently rotate to mix; do not
pain, nausea, vomiting. Misc: chills, fe- shake or agitate. Use diluted solution
ver, hypersensitivity reactions including immediately or refrigerate up to 24 hr
ANAPHYLAXIS. followed by up to 24 hr at room tem-
Interactions perature during infusion. Rate: Infuse
Drug-Drug: None noted. over at least 3.5 (100 mL) or 4.5 hr
(250 mL) through a low-protein bind-
Route/Dosage ing infusion set with a low-protein bind-
IV (Adults and Children 5 yr): 2 mg/ ing 0.2 micron in-line filter.
kg once weekly; pretreatment with antihis-
tamines with/without antipyretics recom- Patient/Family Teaching
mended. Explain the purpose of elosulfate alfa to
patient.
Availability Advise patient to notify health care pro-
Solution for intravenous use (re- fessional immediately if signs and symp-
quires further dilution): 5 mg/5ml sin- toms of anaphylaxis occur.
gle-use vial. Advise female patients to notify health
NURSING IMPLICATIONS care professional if pregnancy is
Assessment ing. Encourage patient to enroll in Mor-
Monitor for signs and symptoms of ana- quio A Registry to collect data on preg-
phylaxis (cough, erythema, throat tight- nant women with MPS IVA treated with
ness, urticaria, flushing, cyanosis, Vimizim by contacting
hypotension, rash, dyspnea, chest dis- [email protected] or call 1-800-983-
comfort, nausea, abdominal pain, 4587.
pg 30 Plate
# 30 # 0-Composite
30 elvitegravir
Evaluation/Desired Outcomes women should not breast feed due to risk
Decreased end organ dysfunction and of viral transmission.
improved musculoskeletal perform- Use Cautiously in: Concurrent use of
ance. drugs that induce the CYP3A enzyme sys-
tem; Geri: Elderly may be more sensitive to
drug effects (consider age-related de-
elvitegravir creased in renal, hepatic and cardiac
(el-vi-teg-ra vir) function, concurrent medications and
Vitekta medical conditions); OB: Use during preg-
nancy only if potential benefit justifies po-
Classification tential fetal risk; Pedi: Safe and effective
Thera: antiretrovirals use in children has not been established.
Pharm: integrase strand Adverse Reactions/Side Effects
transfer inhibitors (INSTI) GI: diarrhea. Misc: immune reconstitu-
tion syndrome.
Pregnancy Category B
Interactions
Indications Drug-Drug: Drugs that induce the
Treatment of HIV-1 infection, in combina- CYP3A system including carbamaze-
tion with a protease inhibitor plus ritona- pine, oxcarbazepine, phenobarbital,
vir and other antiretrovirals in treatment- and phenytoin canpblood levels/effec-
experienced adults. tiveness andqrisk of viral resistance (con-
sider other anticonvulsants); similar ef-
Action fects may occur with rifampin and
Acts as an integrase strand transfer inhibi- rifapentine (concurrent use not recom-
tor; inhibits an enzyme necessary for viral mended); dexamethasone (consider al-
replication. Therapeutic Effects: ternative corticosteroid), cobicistat, efa-
Slowed progression of HIV infection and virenz, and nevirapine(concurrent use
decreased occurrence of sequelae. should be avoided) and bosentan (dis-
Pharmacokinetics continue bosentan at least 36 hr prior to
Absorption: Absorption follows oral ad- starting elvitegravir, wait 10 days before
ministration. restarting atpdose of 62.5 mg daily or
Distribution: Unkown. ever other day with careful titration). Ant-
acids maypblood levels/effectiveness
Protein Binding: 98 99%. andqrisk of viral resistance by forming
Metabolism and Excretion: Metabo- complexes in the GI (separate doses by 2
lized by CYP3A, 94.5% eliminated in feces, hr). Blood levels and the risk of toxicity
6.7% in urine. areqby atazanavir/ritonavir (lower el-
Half-life: Elvitegravir 12.9 hr, with vitegravir dose required) and lopinavir/
ritonavir 8.7 hr. ritonavir (lower elvitegravir dose re-
TIME/ACTION PROFILE (blood quired). Mayqblood levels and risk of
levels) toxicity from ketoconazole (daily keto-
conazole dose should not exceed 200
ROUTE ONSET PEAK DURATION mg), rifabutin (prifabutin dose to 150
PO unknown 4 hr 24 hr mg every other day or three times weekly)
and bosentan(initiate bosentan at 62.5
Contraindications/Precautions mg daily or every other day and titrate
Contraindicated in: Should not be carefully). Maypblood levels and effec-
used concurrently with cobicistat, efavi- tiveness of bocepravir and telaprevir
renz, nevirapine, rifampin, rifapentine, (concurrent use not recommended). May
bocepravir, telaprevir, other elvitegravir- plevels of ethinyl estradiol in hor-
containing agents, norgestimate/ethinyl monal contractives leading topcontra-
estradiol or St. Johns wort; Severe hepatic ceptive efficacy (alternative non-hormonal
impairment; Lactation: HIV-infected contraceptive recommended).
pg 31 Plate
# 1 # 0-Composite
elvitegravir 31
Drug-Natural Products: St. Johns gravir as directed with food and with a
wort canpblood levels/effectiveness and protease inhibitor (atazanavir, daruna-
qrisk of viral resistance (concurrent use vir, fosamprenavir, lopinavir/ritonavir,
should be avoided). or tipravavir) and ritonavir on a regular
Drug-Food: Didanosine(needs to be dosing schedule. Do not stop taking el-
given on an empty stomach) should be vitegravir without consulting health care
given 1 hr before or 2 hr after elvitegravir professional. Advise patient to read Pa-
(needs to be given with food). tient Information prior to starting
Route/Dosage therapy and with each Rx refill in case
of change.
An additional antiretroviral must Inform patient that elvitegravir does not
be coadministered in addition to cure AIDS or prevent associated or op-
elvitegravir, a protease inhibitor portunistic infections. Elvitegravir does
and ritonavir. not reduce the risk of transmission of
PO (Adults): If used with ataznavir 300 HIV to others through sexual contact or
mg once daily with 100 mg ritonavir blood contamination. Caution patient to
daily or lopinavir 400 mg once daily use a condom during sexual contact
with ritonavir 100 mg twice daily 85 and to avoid sharing needles or donat-
mg once daily. ing blood to prevent spreading the AIDS
PO (Adults): If used with darunavir virus to others.
600 mg once daily with 100 mg ritona- Advise patient to notify health care pro-
vir twice daily or fosamprenavir 700 mg fessional of all Rx or OTC medications,
twice daily with ritonavir 100 mg twice vitamins, or herbal products being
daily or tipranavir 500 mg twice daily taken and consult health care profes-
with ritonavir 200 mg twice daily sional before taking any new medica-
150 mg once daily. tions, especially St. Johns Wort. Elvite-
Availability gravir interacts with many other drugs.
Tablets: 85 mg, 150 mg. Follow instructions for specific timing
of or avoiding other medications.
NURSING IMPLICATIONS Advise patient to notify health care pro-
fessional if signs and symptoms of im-
Assessment mune reconstitution syndrome (signs
Assess patient for change in severity of and symptoms of infection or inflamma-
HIV symptoms and for symptoms of option) occur.
portunistic infections during therapy. Advise female patient to notify health
Potential Nursing Diagnoses care professional if pregnancy is
Risk for infection (Indications) planned or suspected or if breast feed-
Deficient knowledge, related to medica- ing. May decrease plasma concentra-
tion regimen (Patient/Family Teaching) tions of hormonal contraceptives. Use
Implementation nonhormonal methods of contraception
PO: Administer once daily with food during therapy. Encourage pregnant pa-
with a protease inhibitor and with rito- tient to enroll in Antiretroviral Preg-
navir. nancy Registry by calling 1-800-258-
Administer antacids at least 2 hr before 4263. Advise patient to avoid breast
or after elvitegravir. feeding.
Patient/Family Teaching Evaluation/Desired Outcomes
Explain purpose of elvitegravir to pa- Slowed progression of HIV infection
tient; elvitegravir does not treat HIV and and decreased occurrence of sequelae.
must be taken with antiretroviral medi-
cations. Instruct patient to take elvite-
pg 32 Plate
# 32 # 0-Composite
32 ferric citrate
Route/Dosage
ferric citrate PO (Adults): 2 tablets (2 g ferric citrate)
(fe-rik si-trate) three times daily. Adjust by 1 2 tablets/
day at weekly (or longer) intervals to at-
Classification tain target phosphorous levels.
Thera: electrolyte modifi- Availability
ers Tablets: 1 g (contains 210 mg ferric
Pharm: phosphate binders iron).
Pregnancy Category B NURSING IMPLICATIONS
Indications Assessment
Control of serum phosphorous in chronic Monitor clinical responses or blood lev-
renal failure patients on dialysis. els of concurrent medications; may de-
crease bioavailability of medications ad-
Action ministered concurrently.
Binds phosphorous and precipitates it as Lab Test Considerations: Monitor
ferric phosphate. Therapeutic Effects: serum phosphorous prior to starting
Maintenance of normal phosphorous lev- and periodically during therapy to keep
els. serum phosphorous at target levels.
Pharmacokinetics Assess iron parameters (serum ferritin
Absorption: Some absorption follows and transferritin saturation TSAT) prior
oral administration and may lead to iron to starting and periodically during ther-
overload. apy. May causeqserum ferritin and
Distribution: Unknown. TSAT requiring reduced dose or dis-
Metabolism and Excretion: Following continuation of IV iron therapy.
binding, precipitated ferric phosphate is Potential Nursing Diagnoses
excreted in stool. Deficient knowledge, related to medica-
Half-life: Unknown. tion regimen (Patient/Family Teaching)
TIME/ACTION PROFILE (lowering of Implementation
serum phosphorous) PO: Administer 3 times daily with
meals.
PO within 1 wk unknown unknown
Instruct patient to take ferric citrate as
Contraindications/Precautions directed and to continue with pre-
Contraindicated in: Iron overload syn- scribed diet.
dromes including hemochromatosis). Advise patient that ferric citrate may
Use Cautiously in: GI bleeding/inflam- cause dark stools; this is normal for
mation; OB: Use cautiously during preg- medications containing iron.
nancy (consider effects on vitamins/nutri- Inform patient that ferric citrate may
ent and potential iron overload); cause diarrhea, nausea, constipation,
Lactation: Consider possible iron trans- and vomiting. Notify health care profes-
port into milk; Pedi: Safe and effective use sional if GI symptoms become severe or
in children has not been established. persistent.
Adverse Reactions/Side Effects fessional of all Rx or OTC medications,
GI: diarrhea, discolored feces, nausea, vitamins, or herbal products being
constipation, vomiting. Misc: iron over- taken and to consult with health care
load. professional before taking other medi-
Interactions cations. Medications may need to be
Drug-Drug: Will bind andpabsorption taken separately from ferric citrate.
of doxycycline (should be given one hr Advise female patient to notify health
prior to ferric citrate). care professional if pregnancy is
pg 33 Plate
# 33 # 0-Composite
finafloxacin 33
planned or suspected or if breast feed- Adverse Reactions/Side Effects
ing. GI: nausea. Local: ear pruritus. Misc:
Evaluation/Desired Outcomes allergic reactions.
Normal serum phosphorous levels. Interactions
Drug-Drug: None noted.
naoxacin Route/Dosage
(fin-a-flox-a-sin) Otic (Adults and Children 1 yr): 4
Xtoro drops in infected ear(s) twice daily for
seven days. Up to 8 drops may be given as
Classification an initial dose if used with an otowick.
Thera: anti-infectives Availability
Pharm: fluoroquinolones Suspension for otic use: 0.3% suspen-
Pregnancy Category C sion 5 mL in 8 mL bottle.
Indications
Treatment of acute otitis externa (AOE) Assessment
caused by susceptible strains of Pseudo- Assess ear pain prior to and periodi-
monas aeruginosa or Staphylococcus cally during therapy.
aureus.
Action Acute pain (Indications)
Inhibits bacterial DNA synthesis by inhibit-
ing the DNA gyrase enzyme. Therapeutic Implementation
Effects: Death of susceptible bacteria Otic: Warm suspension by holding bot-
with resolution of infection. tle in hand for 1 to 2 min prior to dos-
ing to avoid dizziness from instillation of
Pharmacokinetics cold suspension. Shake well before use.
Absorption: Minimal systemic absorp- Instill 4 drops into affected ear twice
tion follows otic use. daily for 7 days. May begin with 8
Distribution: Unknown. drops, followed by 4 drops, in patients
Metabolism and Excretion: Un- requiring use of an otowick. Have pa-
known. tient lie with affected ear upward for 60
Half-life: Unknown. seconds to facilitate penetration of
drops into ear canal. Repeat with other
TIME/ACTION PROFILE (cessation of
ear if necessary.
ear pain)
Instruct patient in proper technique for
otic unknown 3.5 days unknown instillation of drops.
Contraindications/Precautions fessional if signs and symptoms of aller-
Contraindicated in: Hypersensitivity; gic reactions (rash) occur.
cross-sensitivity with other fluoroquinolo- Advise female patients to notify health
nes may occur. care professional if pregnancy is
Use Cautiously in: OB: Use in preg- planned or suspected or if breast feed-
nancy only if potential benefit justifies po- ing.
tential risk to the fetus; Lactation: Use cau-
tiously if breast feeding; Pedi: Safe and Evaluation/Desired Outcomes
effective use in children 1 yr has not Resolution of signs and symptoms of
been established. acute otitis externa (AOE).
pg 34 Plate
# 1 # 0-Composite
34 fomepizole
Misc: minor allergic reactions (mild
fomepizole rash, eosinophilia).
(fo-mep-i-zole) Interactions
Antizol Drug-Drug: None noted.
Classification Route/Dosage
Thera: antidotes IV (Adults): Loading dose 15 mg/kg,
then 10 mg/kg every 12 hours for four
Pharm: enzyme inhibitors doses, then 15 mg/kg every 12 hours until
Pregnancy Category C levels of methanol or ethylene glycol are
undetectable or 20 mg/dL and patient is
Indications asymptomatic with normal pH. Patients
Antidote for ethylene glycol (antifreeze) or requiring hemodialysis (beginning)
methanol (windshield washer fluid) poi- wait at least 6 hr after initiating hemodialy-
soning, alone or with hemodialysis (for sis to give next scheduled dose; during
ethylene glycol or methanol levels 50 hemodialysis give dose every 4 hr;
mg/dL, renal failure or significant meta- when hemodialysis is completed if
bolic acidosis). time between last dose and end of dialysis
is 1 hr, do not administer dose at the
Action end of hemodialysis, if time between last
Inhibits initial metabolism of ethylene gly- dose and end of hemodialysis is 1 3 hr
col or methanol to toxic metabolites. give 1/2 of next scheduled dose, if time
Therapeutic Effects: Decreased mor- between last dose and end of hemodialysis
bidity and mortality in ethylene glycol and is 3 hr give next scheduled dose, Treat-
methanol poisoning. ment is continued until levels of methanol
Pharmacokinetics or ethylene glycol are undetectable or
Absorption: IV administration results in 20 mg/dL and patient is asymptomatic
complete bioavailability. with normal pH.
Distribution: Distributes to total body Availability
water. Solution for IV injection (requires
Metabolism and Excretion: Mostly further dilution): 1 g/mL in 1.5 mL vi-
metabolized, less than 1 3.5% excreted als.
unchanged in urine.
Half-life: Unknown. NURSING IMPLICATIONS
TIME/ACTION PROFILE Assessment
Monitor for signs and symptoms of ac-
cumulation of toxic metabolites, gly-
IV rapid end of in- 12 hr colic and oxalic acids (ethylene glycol)
fusion and formic acid (methanol) (metabolic
Contraindications/Precautions acidosis, nausea/vomiting, seizures, stu-
Contraindicated in: Hypersensitivity to por, coma, calcium oxaluria, acute tu-
fomepizole or other pyrazoles. bular necrosis, blindness, death) prior
Use Cautiously in: OB: May cause fetal to and frequently during therapy.
Monitor for signs and symptoms of al-
harm, use in pregnancy only if clearly
needed; Geri: Safe and effective use in el- lergic reaction (mild rash, eosino-
philia) during infusion.
derly patients has not been established;
Assess ECG periodically during therapy;
Lactation: Use cautiously if breast feeding;
acidosis and electrolyte imbalances may
Pedi: Safe and effective use in children has affect cardiovascular system. Electroen-
not been established. cephalography may be required in co-
Adverse Reactions/Side Effects matose patients.
CNS: headache, dizziness, drowsiness. Lab Test Considerations: Monitor
GI: nausea, dysguesia/metallic taste. serum levels of ethylene glycol and/or
pg 35 Plate
# 35 # 0-Composite
insulin, human inhalation 35

methanol. Lethal dose of ethylene glycol running vial under warm water or hold-
in humans is 1.4 mL/kg. Lethal dose of ing in hand. Solidification does not af-
methanol in humans is 1 2 mL/kg. fect efficacy, safety, or stability. Dilu-
Monitor arterial blood gases, pH, elec- ent: Withdraw dose from vial and inject
trolytes, anion gap, BUN, creatinine, into at least 100 mL of 0.9% NaCl or
and urinalysis frequently during ther- D5W. Mix well. Do not administer solu-
apy. Poisoning may cause metabolic actions that are hazy, discolored, or con-
idosis, acute renal failure (ethylene gly- tain a precipitate. Solution is stable for
col), adult respiratory distress 24 hrs if refrigerated or at room tem-
syndrome, visual disturbances (metha- perature; do not use beyond 24 hrs.
nol) and hypocalcemia. Rate: Infuse slowly over at least 30
Monitor serum and urine ethylene gly- min.
col concentrations and for presence of Patient/Family Teaching
urinary oxalate crystals frequently in pa- Explain purpose of fomepizole to pa-
tients poisoned with ethylene glycol. tient.
Monitor serum methanol concentra- Advise patient to notify health care pro-
tions frequently in patients poisoned fessional if signs and symptoms of aller-
with methanol. gic reaction occur.
Fomepizole may cause transientlyqse-
rum transaminases. Monitor hepatic Evaluation/Desired Outcomes
enzymes periodically during therapy. Ethylene glycol or methanol concentra-
Monitor WBC periodically during ther- tions 20 mg/dL or undetectable, and
apy. May cause eosinophilia. asymptomatic patient with normal pH.
Prevention of organ damage.
Risk for suicide (Indications)
Implementation insulin, human
Supportive therapy with fluids and so- inhalation (in-soo-lin)
dium bicarbonate, supplementation Afrezza
with potassium, and calcium, and oxy-
gen are usually necessary. Hemodialysis Classification
is needed if patient is anuric, has severe Thera: antidiabetics
metabolic acidosis or azotemia, or has Pharm: hormones
high ethylene glycol or methanol con-
centrations (50 mg/dL). Pregnancy Category C
Begin treatment with fomepizole imme-
diately upon suspicion of ethylene gly- Indications
col or methanol ingestion based on pa- Control of hyperglycemia in patients with
tient history and/or anion gap metabolic diabetes mellitus.
acidosis, increased osmolar gap, visual Action
disturbances, oxylate crystals in urine Lowers blood glucose by: stimulating glu-
OR documented serum ethylene glycol cose uptake in skeletal muscle and fat, in-
or methanol concentrations 20 m g/ hibiting hepatic glucose production. Other
dL. actions: inhibition of lypolysis and prote-
Discontinue fomepizole when ethylene
olysis, enhanced protein synthesis. Ther-
glycol or methanol concentrations are apeutic Effects: Control of hyperglyce-
undetectable or have been reduced
mia in diabetic patients.
20 mg/dL, and patient is asympto-
matic with normal pH. Pharmacokinetics
Intermittent Infusion: If fomepizole Absorption: Rapidly absorbed from
solution becomes solid in vial, liquify by lungs.
pg 36 Plate
# 36 # 0-Composite
36 insulin, human inhalation

Distribution: Widely distributed. gens, glucagon, isonazid, niacin, oral
Metabolism and Excretion: Metabo- (hormonal contraceptives), pheno-
lized by liver, spleen, kidney, and muscle. thiazines, progestogens (in hormonal
Half-life: 28 39 min. contraceptives), protease inhibitors,
somatropin, sympathomimetic agents
TIME/ACTION PROFILE (effect on including albuterol, epinephrine and
blood glucose) terbutabline and thyroid hormones.
ROUTE ONSET PEAK DURATION Concurrent use of anti-adrenergics in-
Inhaln within 30 3060 160 min cluding beta-blockers, clonidine, gua-
min min nethidine or reserpine maypsigns any
symptoms of hypoglycemia. Concomitant
Contraindications/Precautions use with thiazolidinediones including
Contraindicated in: Hypersensitivity to pioglitazone or rosiglitazone (qrisk
regular insulin or any other components of fluid retention and worsening HF). Con-
of the formulation; Hypoglycemia; Smok- current use of inhaled albuterol mayq
ers or those who have recently stopped absorpion.
smoking; Lung disease, including asthma, Drug-Natural Products: Glucosa-
COPD and active lung cancer; Lactation: mine may worsen blood glucose control.
Discontinue breast feeding or inhaled in- Fenugreek, chromium, and coenzyme
sulin. Q-10 may produce additive hypoglycemic
Use Cautiously in: Stress and infection effects.
(may temporarilyqinsulin require- Route/Dosage
ments); Renal/hepatic dysfunction (may Inhaln (Adults): 4 or 8 units inhaled at
pinsulin requirements); Concomitant the beginning of a meal; dose depends on
use with thiazolidinediones including a variety of patient factors.
pioglitazone or rosiglitazone (qrisk of
fluid retention and worsening HF); OB: Availability
Pregnancy may temporarilyqinsulin re- Single use cartridge for inhalation
quirements, should not be used during using Afrezza-specific inhaler: 4 units,
pregnancy unless potential benefit justifies 8 units.
potential risk to the fetus; Pedi: Safety not NURSING IMPLICATIONS
established in children 18 yr.
Assessment
Adverse Reactions/Side Effects Before starting therapy perform a de-
CNS: fatigue. Resp: BRONCHOSPASM, tailed medical history, physical exami-
cough,plung function, throat pain/irrita- nation. and spirometry (FEV1 to deter-
tion. GI: diarrhea, nausea. Endo: HYPO- mine potential lung disease. Assess
GLYCEMIA. F and E: HYPOKALEMIA. Metab:
pulmonary function via spirometry at
weight gain. Misc: allergic reactions in- baseline, after 6 mo and annually there-
cluding ANAPHYLAXIS. after; more frequently if patient has pul-
Interactions monary symptoms such as wheezing,
Drug-Drug: Concurrent use of other bronchospasm, breathing difficulties,
antidiabetics, ACE inhibitors, ARBs, or persistent, recurring cough. May re-
disopyrimide, fibrates, fluoxetine, quire discontinuation of inhalation ther-
MAOIs, pentoxifyllin, pramlintide, apy.
propoxyphene, salicylates, somasta- Assess patient periodically for symp-
tin analogs including octreotide, and toms of hypoglycemia (anxiety; restless-
sulfonamide anti-infectivesqrisk of ness; tingling in hands, feet, lips, or
hypoglycemia, dose modifications may be tongue; chills; cold sweats; confusion;
necessary. Glucose lowering effects may cool, pale skin; difficulty in concentra-
bepby atypical antipsychotics includ- tion; drowsiness; nightmares or trouble
ing clozapine, and olanzapine, corti- sleeping; excessive hunger; headache;
costeroids, danazol, diuretics, estro- irritability; nausea; nervousness; tachy-
pg 37 Plate
# 37 # 0-Composite
insulin, human inhalation 37

cardia; tremor; weakness; unsteady down, shaken, or dropped after car-
gait) and hyperglycemia (confusion, tridge is inserted but before dose given.
drowsiness; flushed, dry skin; fruit-like If these occur, replace cartridge before
breath odor; rapid, deep breathing, use.
polyuria; loss of appetite; unusual Dosing: Insulin nave patients: Start
thirst) during therapy. with 4 units before each meal. Patients
Monitor for bronchospasm. Occurs using subcut mealtime (Prandial) In-
rarely, but if bronchospasm occurs, dis- sulin: Determine appropriate dose for
continue therapy and notify health care each meal by converting from injected
professional immediately. Re-adminis- dose using dose conversion. Patients
tration should be attempted during using subcut pre-mixed insulin: Esti-
close monitoring. mate mealtime injected dose by dividing
Assess for respiratory illness. Monitor half total daily injected pre-mixed insu-
blood glucose concentrations closely; lin dose equally among three meals.
may require dose adjustments. Convert each estimated injected meal-
Monitor body weight periodically. May time dose to appropriate inhalation
cause weight gain. Changes in weight dose using dose conversion. Administer
may necessitate changes in insulin dose. half of total daily injected pre-mixed
Lab Test Considerations: Monitor dose as an injected basal insulin dose.
blood glucose every 6 hr during ther- Dose conversion: If injected mealtime
apy, more frequently in ketoacidosis insulin dose is up to 4 units: Adminis-
and times of stress. A1C may be moni- ter one 4 unit inhalation dose. If in-
tored every 3 6 mo to determine effec- jected mealtime insulin dose is 5 8
tiveness. units: Administer one 8 unit inhalation
Monitor serum potassium in patients at dose. If injected mealtime insulin
risk for hypokalemia (those using po- dose is 9 12 units: Administer one 4
tassium-lowering agents, those receiv- unit and one 8 unit inhalation dose (12
ing IV insulin) periodically during ther- units). If injected mealtime insulin
apy. dose is 13 16 units: Administer two 8
Toxicity and Overdose: Overdose is unit inhalation doses (16 units). If in-
manifested by symptoms of hypoglyce- jected mealtime insulin dose is 17
mia. Mild hypoglycemia may be treated 20 units: Administer one 4 unit and two
by ingestion of oral glucose. Severe hy- 8 unit inhalation doses (20 units). If
poglycemia is a life-threatening emer- injected mealtime insulin dose is 21
gency; treatment consists of IV glucose, 24 units: Administer three 8 unit inha-
glucagon, or epinephrine. lation doses (24 units).
Adjust dose based on metabolic needs.
Potential Nursing Diagnoses blood glucose monitoring results, and
Noncompliance (Patient/Family Teaching) glycemic control goal. Dose may need
Implementation to be adjusted with changes in physical
Inhalation insulin must be used in com- activity, meal patterns, renal and he-
bination with long-acting subcutaneous patic function, or during acute illness.
insulin. Monitor blood glucose carefully in pa-
Afrezza should only be used with Af- tients receiving high doses of inhalation
rezza inhaler. insulin. If blood glucose control is not
Inhaln: Administer at beginning of achieved with increased inhalation
meal. Keep inhaler level; white mouth- doses, consider use of subcut mealtime
piece on top and purple base on the insulin.
bottom after inserting cartridge. Loss of Patient/Family Teaching
drug effect occurs if inhaler is upside Instruct patient on proper technique for
down, held with mouthpiece pointing administration. Advise patient to read
pg 38 Plate
# 38 # 0-Composite
38 ledipasvir/sofosbuvir
Medication Guide before starting ther- disease and treatment regimen at all
apy and with each Rx refill in case of times.
changes. Emphasize the importance of regular
Advise patient to notify health care pro- follow-up, especially during first few
fessional immediately of signs and weeks of therapy.
symptoms of allergic reaction (rash,
trouble breathing, fast heartbeat, sweat- Evaluation/Desired Outcomes
ing) occur. Control of blood glucose levels in dia-
Explain to patient that this medication betic patients without the appearance of
controls hyperglycemia but does not hypoglycemic or hyperglycemic epi-
cure diabetes. Therapy is long term. sodes.
Instruct patient in proper testing of se-
rum glucose and ketones. These tests
should be closely monitored during pe-
riods of stress or illness and health care ledipasvir/sofosbuvir
professional notified of significant
changes.
(led-i-pas-vir/soe-fos-bue-
May cause dizziness. Caution patient to vir)
avoid driving or other activities requir- Harvoni
ing alertness until response to medica- Classification
tion is known.
Caution patient to avoid smoking while Thera: antivirals
taking inhaled insulin. Pharm: NS5A inhibitors-
Emphasize the importance of compli- polymerase inhibitors
ance with nutritional guidelines and
regular exercise as directed by health Pregnancy Category B
care professional.
professional of all Rx or OTC medica-
Indications
Treatment of adults with chronic hepatitis
tions, vitamins, or herbal products be-
C (CHC) genotype 1 infection.
ing taken and to consult health care
professional before taking other Rx,
OTC, or herbal products, especially in- Action
haled medications. Ledipasvir inhibits NS5A, a protein re-
Advise patient to notify health care pro- quired for viral replication. Sofosbuvir
fessional of medication regimen prior inhibits RNA-dependent RNA polymerase,
to treatment or surgery. resulting in inhibition of viral replication.
Advise patient to notify health care pro- Therapeutic Effects: Decreased HCV
fessional if nausea, vomiting, or fever RNA levels with decreased severity and se-
develops, if unable to eat regular diet, quelae of CHC.
or if blood glucose levels are not con-
trolled. Pharmacokinetics
Instruct patient on signs and symptoms Ledipasvir
of hypoglycemia and hyperglycemia and Absorption: Well absorbed following
what to do if they occur. oral administration.
Advise patient to notify health care pro- Distribution: Unknown.
fessional if pregnancy is planned or sus- Protein Binding: 99.8%.
pected or if breast feeding or planning Metabolism and Excretion: Minimal
to breast feed. metabolism, undergoes biliary excretion.
Patients with diabetes mellitus should Mostly excreted unchanged in feces
carry a source of sugar (candy, glucose (86%), 1% eliminated in urine.
gel) and identification describing their Half-life: 47 hr.
pg 39 Plate
# 39 # 0-Composite
ledipasvir/sofosbuvir 39
Sofosbuvir Ledipasvir inhibits P-gp and mayqlevels
Absorption: Rapidly metabolized fol- of substrates of P-gp. Acid-reducing
lowing absorption (extensive first-pass ef- agents mayplevels of ledispasvir; sepa-
fect). rate antacids including magnesium and
Distribution: Unknown. aluminum hydroxide by 4 hr, adminis-
Protein Binding: 61 65%. ter H2-receptor antagonists including
Metabolism and Excretion: Exten- famotidine simultaneously or 12 hr apart
sively metabolized with much conversion (dose of antagonist should not exceed
to GS-461203, an active antiviral moiety, famotidine 40 mg twice daily or equiva-
then converted GS-331007, which does lent), proton-pump inhibitors includ-
not have antiviral activity. 80% excreted in ing omeprazole 20 mg daily or equiva-
urine mostly as GS-331007 (3.5% as un- lent may be given simultaneously. Mayq
changed drug), 14% excreted in feces, levels/effects/risk of toxicity with di-
2.5% excreted in expired air. goxin(therapeutic monitoring recom-
Half-life: Sofosbuvir 0.4 hr; GS- mended). Level and effectivenesspby
331007 27 hr. carbamazepine, phenytoin, pheno-
barbital and oxcarbazepine concur-
TIME/ACTION PROFILE (blood rent use in not recommended. Levels and
levels) effectiveness may bepby concurrent use
ROUTE ONSET PEAK DURATION of rifabutin and rifapentine; concur-
ledipasvir unknown 45 hr 24 hr rent use is not recommended.qlevels and
sofosbuvir unknown 0.81 hr 24 hr risk of adverse reactions from tenofovir
and tenofovir-containing combina-
Sofosbuvir (2 4 hr for GS-331007). tions (dosage adjustments may be neces-
Contraindications/Precautions sary, consider alternative regimens). Lev-
Contraindicated in: Should not be els and effectiveness arepby tipranavir/
used with other drugs/regimens that al- ritonavir; concurrent use is not recom-
ready containing sofosbuvir; Concurrent mended. Concurrent use with simeprevir
use of P-gp inducers, some anticonvul- mayqlevels of simeprevir and ledipasvir;
sants, some antivirals and rosuvastatin; Se- concurrent use is not recommended.q
vere renal impairment (eGFR 30 mL/ levels and risk of myopathy/rhabdomy-
min/1.73 m2) or end stage renal disease olysis with rosuvastatin; concurrent use
(no dose recommendation). is not recommended.
Use Cautiously in: Decompensated cir- Drug-Natural Products: Concurrent
rhosis (safe and effective use has not been use with St. Johns wortpblood levels
established); Geri: Elderly may be more and effectiveness; concurrent use in con-
sensitive to drug effects; Lactation: Weigh traindicated.
benefits of breast feeding against possible
adverse effects; OB: Use during pregnancy Route/Dosage
only if potential benefit justifies fetal risk;
PO (Adults): Ledipasvir 90 mg/sofosbu-
Pedi: Safe and effective use has not been vir 400 mg (one tablet) once daily for 12
established. wk in patients who are treatment nave
Adverse Reactions/Side Effects with/without cirrhosis or who are treat-
CNS: fatigue, headache, insomnia. GI: di- ment-experienced without cirrhosis, for
arrhea, nausea. 24 wk in patients who are treatment-expe-
Interactions rienced with cirrhosis.
Drug-Drug: Concurrent use of P-gp in-
ducers including rifampinplevels and Availability
effectiveness of both ledipasvir and sofos- Tablets: ledipasvir 90 mg/sofosbuvir 400
buvir; concurrent use in contraindicated. mg.
pg 40 Plate
# 40 # 0-Composite
40 lenvatinib
lenvatinib (len-va-ti-nib)
Assessment Lenvima
Monitor symptoms of hepatitis during
therapy. Classification
Lab Test Considerations: May Thera: antineoplastics
causeqserum bilirubin and lipase lev-
els. Pharm: kinase inhibitors
Potential Nursing Diagnoses Indications

Risk for infection (Indications) Treatment of locally recurrent or meta-
static/progressive, radioactive-iodine-re-
Implementation fractory differentiated thyroid cancer.
PO: Administer once daily with or with- Action
out food. Acts as a receptor tyrosine kinase inhibi-
tor; inhibits kinase activities of various
Patient/Family Teaching vascular endoethelial growth factor recep-
Instruct patient to take ledipasvir/sofos- tors (VEGFRs), resulting in decreased
buvir at the same time each day for the pathogenic angiogenesis, tumor growth
full course of therapy. Take missed and spread. Therapeutic Effects: De-
doses as soon as remembered on same creased progression of differentiated thy-
day; do not take more than 1 tablet in a roid cancer.
day. Do not stop taking ledipasvir/sofos- Pharmacokinetics
buvir without consulting health care Absorption: Well absorbed following
professional. Advise patient to read Pa- oral administration.
tient Information prior to starting Distribution: Unknown.
therapy and with each Rx refill in case Protein Binding: 98 99%.
of changes. Metabolism and Excretion: Metabo-
Inform patient that ledipasvir/sofosbu- lized by CYP3A and aldehyde oxidase; 64%
vir may not reduce the risk of transmis- eliminated in feces, 25% in urine.
sion of CHC to others; use appropriate Half-life: 28 hr.
precautions to prevent transmission.
Instruct patient that ledipasvir/sofosbu- TIME/ACTION PROFILE (improvement
vir should not be shared with others; in progression-free survival)
may be harmful. ROUTE ONSET PEAK DURATION
PO within 2 mo 8 mo throughout
fessional of all Rx or OTC medications, treatment
vitamins, or herbal products being
taken and consult health care profes- Contraindications/Precautions
sional before taking any new medica- Contraindicated in: Lactation: Discon-
tions, especially St. Johns Wort. tinue lenvatinib or discontinue breast
Instruct patient to take antacids con- feeding; OB: Pregnancy (may cause fetal
taining aluminum or magnesium 4 hrs harm, effective contraception required,
before or 4 hrs after ledipasvir/sofosbu- may result in reduced fertility).
vir. Use Cautiously in: Hypertension (con-
Advise female patient to notify health trol blood pressure before initiating treat-
care professional if pregnancy is ment, may need to withhold/discontinue
planned or suspected or if breast feed- for life-threatening elevation); History of
ing. heart failure (may need to withhold/dis-
continue for worsening HF); History of
Evaluation/Desired Outcomes congenital long QTc syndrome, HF, brad-
Decreased HCV RNA levels with de- yarrhythmias, concurrent use of drugs that
creased severity and sequelae of CHC. prolong QTc, including Class Ia and III
pg 41 Plate
# 1 # 0-Composite
lenvatinib 41
antiarrhythmics (qrisk of further QTc Renal Impairment
prolongation and serious arrthythmias, PO (Adults): CCr30 mL/min 14 mg
may require interruption/discontinuation once daily.
of lenvatinib); Severe hepatic or renal Hepatic Impairment
impairment (lower dose required); De- PO (Adults): Child Pugh C or worse
hydration/volume depletion (qrisk of 14 mg once daily.
renal impairment, may need to withhold/
discontinue for worsening renal func- Availability
tion); Hypocalcemia (replace calcium, if Capsules: 4 mg, 10 mg.
persistent may require dose adjustment/ NURSING IMPLICATIONS
interruption); History of reversible pos-
terior leukencephalopathy syndrome Assessment
(may required dose adjustment/inter- Assess blood pressure prior to and after
ruption); May damage male reproductive 1 wk, then every 2 wks for first 2 mo,
tissue resulting in decreased fertility; and then at least moly thereafter during
Pedi: Safe and effective use in children therapy. Initiate or adjust medication
has not been established. management to control blood pressure.
Withhold lenvatinib for Grade 3 hyper-
Adverse Reactions/Side Effects tension that persists despite anti-
CNS: fatigue, insomnia, headache. hypertensive therapy. Resume at a re-
Resp: cough. CV: ARTERIAL THROMBO- duced dose (1st occurrence 20 mg/
EMBOLIC EVENTS, HEART FAILURE, HYPER- day; 2nd occurrence 14 mg/day;
TENSION, QTC PROLONGATION, hypoten- 3rd occurrence 10 mg/day) when
sion. EENT: dysphonia, epistaxis. GI: hypertension is controlled or Grade 2.
GASTROINTESTINAL PERFORATION/FISTULA Discontinue lenvatinib for life-threaten-
FORMATION, HEPATOTOXICITY, abdominal ing hypertension.
pain,pappetite, diarrhea, dry mouth, Monitor for clinical signs and symptoms
dysgeusia, nausea, stomatitis, vomiting, of cardiac decompensation (shortness
qliver enzymes. GU: NEPHROTIC SYN- of breath, swollen ankles) during ther-
DROME, proteinuria, renal impairment. apy. Withhold lenvatinib for Grade 3
Derm: alopecia, palmar-plantar ery- cardiac dysfunction until improved to
throdysesthesia syndrome, rash, hyper- Grade 0 or 1 or baseline. Resume at re-
keratosis. Endo: impaired thyroid stim- duced dose (1st occurrence 20 mg/
ulating hormone suppression. F and E: day; 2nd occurrence 14 mg/day;
dehyration, hypocalcemia, hypokalemia. 3rd occurrence 10 mg/day) or dis-
Hemat: hemorrhagic events, thrombo- continue depending of severity and per-
cytopenia. Metab:pweight. MS: ar- sistence of cardiac dysfunction.
thralgia/myalgia. Neuro: reversible pos- Monitor for signs and symptoms of arte-
terior leukoencephalopathy syndrome rial thromboembolic events (chest
(RPLS). pain, acute neurologic symptoms of MI
or stroke) during therapy. Discontinue
Interactions lenvatinib if event occurs.
Drug-Drug: Concurrent use of drugs Assess for signs and symptoms of gas-
that prolong QTc, including Class Ia and trointestinal perforation or fistula for-
III antiarrhythmics mayqrisk of further mation (severe abdominal pain) during
QTc prolongation and serious arrhythmias therapy. Discontine lenvatinib if gastro-
(may require interruption/discontinuation intestinal perforation or fistula occurs.
of lenvatinib). Monitor ECG for patients with congen-
tial long QT syndrome, congestive heart
Route/Dosage failure, bradyarrhythmias, or those tak-
PO (Adults): 24 mg once daily. ing drugs known to prolong QT interval.
pg 42 Plate
# 42 # 0-Composite
42 lenvatinib
Withhold lenvatinib for development of lenvatinib for 2 g proteinuria/24 hrs
Grade 3 QT interval prolongation. Re- and resume at reduced dose (1st oc-
sume at reduced dose (1st occurrence currence 20 mg/day; 2nd occur-
20 mg/day; 2nd occurrence 14 rence 14 mg/day; 3rd occurrence
mg/day; 3rd occurrence 10 mg/ 10 mg/day) when proteinuria 2 g/
day) when QT prolongation resolves to 24 hrs. Discontinue lenvatinib for ne-
Grade 0 or 1. phrotic syndrome.
Monitor for signs and symptoms of re- Monitor BUN and creatinine prior to
versible posterior leukoencephalopathy and periodically during therapy. With-
syndrome (RPLS) (severe headache, hold lenvatinib for Grade 3 or 4 renal
seizures, weakness, confusion, blind- failure/impairment until resolved to
ness or change in vision) during ther- Grade 0 or 1 or baseline. Resume at re-
apy. If symptoms occur, confirm diag- duced dose (1st occurrence 20 mg/
nosis with MRI. Withhold lenvatinib for day; 2nd occurrence 14 mg/day;
RPLS until fully resolved. Resume at re- 3rd occurrence 10 mg/day) or dis-
duced dose (1st occurrence 20 mg/ continue depending of severity and per-
day; 2nd occurrence 14 mg/day; sistence of renal impairment.
3rd occurrence 10 mg/day) or dis- Monitor and correct electrolyte abnor-
continue depending on severity and malities. Monitor serum calcium levels
persistence of neurologic symptoms. at least moly and replace calcium as
Monitor for bleeding (severe and per- needed during therapy. Interrupt and
sistent nose bleeds, vomiting blood, red adjust lenvatinib dose based on severity,
or black stools, coughing up blood or presence of ECG changes, and persist-
blood clots, heavy or new onset vaginal ence of hypocalcemia. May cause hypo-
bleeding) during therapy. Withhold len- kalemia, hypomegnesemia, hypoglyce-
vatinib for Grade 3 hemorrhage until mia, hypercalcemia, and hyperkalemia.
resolved to Grade 0 or 1. Resume at re- Monitor TSH levels moly and adjust thy-
duced dose (1st occurrence 20 mg/ roid replacement medication as needed
day; 2nd occurrence 14 mg/day; in patients withpthyroid levels.
3rd occurrence 10 mg/day) or dis- May causeqserum lipase and amylase,
continue depending on severity and hypercholesterolemia, andpplatelet
persistence of hemorrhage. Discontinue count.
lenvatinib if Grade 4 hemorrhage oc- Potential Nursing Diagnoses
curs. Deficient knowledge, related to medica-
Lab Test Considerations: Monitor tion regimen (Adverse Reactions)
serum ALT and AST levels for hepato-
toxicity prior to and every 2 wks for first Implementation
2 mo, and at least moly thereafter dur- PO: Administer two 10 mg capsules
ing therapy. Withhold lenvatinib for and one 4 mg capsule to make 24 mg
Grade 3 cardiac dysfunction until im- at the same time each day without re-
proved to Grade 0 or 1 or baseline. Re- gard to food.
sume at reduced dose (1st occurrence Patient/Family Teaching
20 mg/day; 2nd occurrence 14 Instruct patient to take lenvatinib as di-
mg/day; 3rd occurrence 10 mg/ rected at the same time each day. Take
day) or discontinue depending of sever- missed dose within 12 hrs or omit and
ity and persistence of hepatotoxicity. take next dose at usual time; do not
May cause hypoalbuminemia,qalka- double doses. Advise patient to read Pa-
line phosphatase, and hyperbilirubine- tient Information before starting ther-
mia. apy and with each Rx refill in case of
Monitor for proteinuria prior to and pe- changes.
riodically during therapy. If urine dip- Advise patient to notify health care pro-
stick proteinuria 2 is detected, ob- fessional promptly if signs and symp-
tain 24 hr urine protein. Withhold toms of high blood pressure, heart
pg 43 Plate
# 1 # 0-Composite
lipid emulsion, injectable 43

problems, blood clots (severe chest (beta oxidation of fatty acids), also pro-
pain or pressure; pain in arms, back, or vide membrane structure/function, pro-
jaw; shortness of breath; numbness or vide precursor for bioactive molecules
weakness on 1 side of body; trouble and gene expression. Therapeutic Ef-
talking; sudden severe headache; sud- fects: Maintenance of lipid homeostasis
den vision changes), liver problems during parenteral nutrition.
(yellow skin or whites of eyes, dark tea
colored urine, light-colored bowel
Pharmacokinetics
movements), severe stomach pain, Absorption: IV administration results in
RPLS, or bleeding occur. complete bioavailability; fatty acids are
Advise patient to notify health care pro- converted to other fatty acids by the liver.
fessional of all Rx or OTC medications, Distribution: Unknown.
vitamins, or herbal products being Metabolism and Excretion: Metabo-
taken and to consult with health care lized by cell to CO2 and water, which are
professional before taking other medi- converted to energy in the form to adeno-
cations. sine triphosphate (ATP). Storage forms al-
May be teratogenic. May cause fertility low continual turnover. Excess CO2 is ex-
problems in males and females. Advise pired via lungs and water is eliminated in
female patient to use effective contra- urine, skin and other tissue surfaces. Ad-
ception during and for at least 2 wks ditional lipids may undergo biliary excre-
following completion of therapy and to tion.
notify health care professional if preg- Half-life: Unknown.
nancy is planned or suspected. Advise TIME/ACTION PROFILE
patient to avoid breast feeding during
therapy. ROUTE ONSET PEAK DURATION
Emphasize importance of lab tests to IV unknown unknown unknown
monitor for adverse reactions.
Evaluation/Desired Outcomes Contraindications/Precautions
Decreased progression of thyroid can- Contraindicated in: Known hypersen-
cer. sitivity to egg or soybean proteins, lipid
emulsion or other contents of product; Se-
vere hyperlipidemia or dyslipidemia.
lipid emulsion, Use Cautiously in: Hepatic impairment;
injectable Severe fluid/electrolyteolic/metab disor-
(lip-id ee-mull-shun) ders (correct prior to use);qtriglyceride
Clinolipid levels (initiate at lower dose, advance in
small increments); Geri: Elderly patients
Classification may be sensitive to effects; OB: Use during
Thera: parenteral nutrition pregnancy only if clearly needed; Lacta-
Pharm: lipid calorie tion: Use cautiously if breast feeding; Pedi:
sources Pre-term/low birth weight infants have
poor lipid clearance (deaths have oc-
Pregnancy Category C curred); does not contain sufficient
amounts of essential fatty acids for routine
Indications use in children.
To provide a source of calories and essen- Adverse Reactions/Side Effects
tial fatty acids when oral/enteral nutrition GI:qliver enzymes, nausea, PARENTERAL
is not possible. NUTRITION-ASSOCIATED LIVER DISEASE,
Action vomiting. Endo: hyperglycemia. Metab:
Provision of calories and fatty acids which fat overload syndrome, hypoproteinemia,
act as substrates for energy production refeeding syndrome,qtriglycerides.
pg 44 Plate
# 2 # 0-Composite
44 lipid emulsion, injectable

Misc: hypersensitivity reactions including slowly increase nutrient intake to pre-
ANAPHYLAXIS. vent syndrome.
Monitor fluid status in patients with pul-
Interactions
monary edema or HF.
Drug-Drug: Maypanticoagulant effect Lab Test Considerations: Obtain se-
of warfarin (due to soybean oil Vitmain rum triglyceride levels to establish base-
K1 content). line value prior to administering lipids.
Route/Dosage If triglyceride values areqinitiate lipid
IV (Adults): Usual dose 1 1.5 g/kg/ infusion at a lower dose, advance in
day (not to exceed 2.5 g/kg/day); dose de- smaller increments, and check triglyc-
pends on multiple considerations includ- eride levels before each adjustment.
ing energy expenditure, clinical status, Monitor serum triglycerides, fluid and
body weight, tolerance, metabolic status electrolyte status, serum osmolarity,
and other energy sources. blood glucose, liver and kidney func-
tion, CBC with platelets and coagulation
Availability parameters periodically during therapy.
Emulsion for intravenous infusion: Reduce dose of lipid infusion in patients
20% lipid emulsion (contains 0.2 g lipids/ with serum triglycerides 400 m g/dL.
mL). Monitor for essential fatty acid defi-
NURSING IMPLICATIONS ciency (EFAD) using serum fatty acid
levels.
Assessment May interfere with anticoagulant activity
Monitor for signs and symptoms of hy- due to content of Vitamin K.
persensitivity or allergic reactions May cause aluminum toxicity in prema-
(tachypnea, dyspnea, hypoxia, bron- ture infants and patients with impaired
chospasm, tachycardia, hypotension, kidney function who receive aluminum
cyanosis, vomiting, nausea, headache, levels 4 to 5 mcg/kg/day. Clinolipid
sweating, dizziness, altered mentation, contains no 25 mc g/L of aluminum.
flushing, rash, urticaria, erythema, py- Potential Nursing Diagnoses
rexia, chills) during infusion. Stop infu- Imbalanced nutrition: less than body re-
sion immediately and treat symptomati- quirements (Indications)
cally if symptoms occur.
Monitor for signs and symptoms of in- Implementation
fections (fever, chills, leukocytosis, hy- Correct severe water and electrolyte dis-
perglycemia) during therapy. Check orders, severe fluid overload states, and
parenteral access device frequently. severe metabolic disorders before infu-
Monitor for signs and symptoms of fat sion of lipids.
overload syndrome (sudden deteriora- IV Administration
tion in patient condition, fever, anemia, Continuous Infusion: Check color of
leukopenia, thrombocytopenia, coagu- oxygen indicator before opening over-
lation disorders, hyperlipidemia, liver wrap. Compare color of indicator to
fatty infiltration or hepatomegaly, dete- reference color printed next to OK sym-
riorating liver function, coma) during bol on indicator label. If color of oxy-
therapy. Usually reversible when lipid gen indicator does not match reference
infusion is discontinued but may occur color do not use solution. Once open
when lipid dose exceeded. use contents immediately; do not store
Carefully monitor severely undernour- for subsequent infusion. Emulsion
ished patients for signs and symptoms should be homogenous milky liquid; do
of refeeding syndrome (intracellular not administer solutions that are discol-
shift of potassium, phosphorous, and ored or contain particulate matter.
magnesium as anabolism develops. Thi- Rate: Do not exceed 0.1 g (equal to
amine deficiency and fluid retention 0.5 mL)/min for first 15 to 30 min of
may develop). Avoid overfeeding and initial infusion. Gradually increase to
pg 45 Plate
# 45 # 0-Composite
mefloquine 45
required rate after 30 min, if tolerated. planned or suspected or if breast feed-
Duration of parenteral nutrition bag ing.
should be 12 to 24 hr depending on Evaluation/Desired Outcomes
clinical status. Do not connect flexile Maintenance of lipid homeostasis.
bags in a series, fully evacuate gas from
flexible bags, and do not use vented IV
administration set with vent in open po- meoquine
sition; may cause air embolism. Use a (meh-flow-kwin)
1.2 micron in-line filter during infusion. Lariam
Do not use infusion sets and lines con-
taining di-2 ehtylhexyl phthalate Classification
(DEHP). If infused alone may be ad- Thera: antimalarials
ministered via central or peripheral Pharm: quinine analogues
vein. If mixed with dextrose or amino
acids, osmolarity of final infusate Indications
should determine venous route. Treatment of mild-to-moderate acute ma-
Additive Compatibility: If mixed with laria caused by susceptible strains of Plas-
dextrose or amino acid solutions check modium falciparum or P. vivax includ-
mixture closely for presence of precipi- ing chloroquine-resistant strains.
tates to determine compatibility. To Prevention of malaria caused by Plasmo-
mix, transfer dextrose to total paren- dium falciparum or P. vivax.
teral nutrition admixture container.
Then transfer amino acids. Then trans- Action
fer lipid emulsion. Do not add additives Eradicates the blood schizonticidal stage
directly into lipid emulsion. Use gentle of malaria. Therapeutic Effects: Reso-
agitation to mix after each additive. In- lution/prevention of malaria.
spect for separation (yellowish streak- Pharmacokinetics
ing or accumulation of yellowish drop- Absorption: Well absorbed following
lets in admixed emulsion); discard if oral administration.
observed. Distribution: Extensive tissue distribu-
Patient/Family Teaching tion including parasitized erythrocytes;
Explain purpose of lipid infusion to pa- crosses the placenta, minimal excretion in
tient. breast milk.
If patient is trained to self-administer Protein Binding: 98%.
lipid infusion at home instruct patient to Metabolism and Excretion: Exten-
inspect bag for particulate matter and sively metabolized by the liver (primarily
evenly distributed liquid, ensure in-line by the CYP3A4 enzyme system), metabo-
filter is used, and emphasize need for lites do not have antimalarial activity. Ex-
periodic lab tests. Advise patient to no- creted mostly in bile and feces as metabo-
tify health care professional immedi- lites. Small amounts excreted in urine.
ately if signs and symptoms of infection Half-life: 2 4 wk.
or allergic reaction occur. TIME/ACTION PROFILE (blood
fessional of all Rx or OTC medications, levels)
vitamins, or herbal products being ROUTE ONSET PEAK DURATION
taken and to consult with health care PO unknown 624 hr several wk
professional before taking other medi-
cations. Contraindications/Precautions
Advise female patient to notify health Contraindicated in: Hypersensitivity
care professional if pregnancy is (cross sensitivity with quinine and quini-
pg 46 Plate
# 46 # 0-Composite
46 mefloquine
dine may occur); Should not be used for Risk of QTc prolongation may beqby
prophylaxis in patients with a history of concurrent use of anti-arrhythmics,
depression, generalized anxiety disorder, beta-blockers, some antihistamines,
psychosis, schizophrenia, major psychiat- tricyclic antidepressants or phenothi-
ric disorder or seizures; Life-threatening azines. Maypantibody response to live
malaria (initial treatment should be with virus vaccines (vaccinations should be
an intravenous drug); Concurrent use of completed 3 days prior to mefloquine.
halofantrine or ketoconazole (qrisk of Concurrent use of inducers of the
serious cardiovascular adverse reactions); CYP3A4 system including rifampin may
Lactation: Discontinue mefloquine or dis- pblood levels and effectiveness. Mayp
continue breast feeding. bood levels and effectiveness of anticon-
Use Cautiously in: Malaria caused by vulsants including carbamazepine, phe-
P. vivax (relapse rates are high, subse- nobarbital, phenytoin or valproates.
quent treatment with and 8 aminoquino- Effects of drugs that are substrates of
line is required); History of suicide at- the P-gp transporter system or inhibi-
tempt or ideation; History of tors of the P-gp transporter system
cardiovascular disease (mayqrisk of ad- may affect or be affected by melfoquine.
verse cardiovascular reactions); Psychiat- Route/Dosage
ric disorders; Hepatic impairment (may PO (Adults): Mild-to-moderate ma-
qblood levels and risk of adverse reac- laria 1250 mg (5 tablets as a single
tions; Concurrent use of anticonvulsants dose), patients with acute P. vivax should
(effectiveness may bep); Concurrent use also be subsequently treated with an 8
of rifampin (maypblood levels and effec- aminoquinoline; prophylaxis 250 mg
tiveness); Geri: Elderly patients may haveonce weekly beginning one wk before ar-
qrisk of adverse cardiovascular reac- rival in endemic area (sooner if concur-
tions; OB: Use during pregnancy only if rent medications decrease tolerance) and
potential benefit justifies potential risk to
continued for 4 wk after returning.
the fetus; Pedi: Safe and effective use inPO (Children 20 kg): Mild-to-moder-
children 6 mos has not been established ate malaria 20 25 mg/kg (may be
(vomiting may necessitate repeat dosing insplit into two doses 6 8 hr apart, if vomit-
older children). ing occurs, all or part of the dose may be
Adverse Reactions/Side Effects repeated); patients with acute P. vivax
CNS: dizziness, fatigue, neuropsychiatric should also be subsequently treated with
symptoms, vertigo. EENT: tinnitus. CV: an 8 aminoquinoline; prophylaxis 5
arrhythmias (including sinus bradycardia, mg/kg once weekly (for patients 45 k
sinus arrhythmia, first degree AV block, g use one 250 mg tablet, if 30 45
abnormal T waves), ECG changes, syn- kg use 3/4 tablet, if 20 30 kg use 1/
cope. GI: abdominal pain, diarrhea, nau- 2 tablet) beginning one wk before arrival
sea, vomiting (qin children). Derm: in endemic area (sooner if concurrent
rash. medications decrease tolerance) and con-
tinued for 4 wk after returning.
Interactions
Drug-Drug: Concurrent use ofhalofan- Availability
trine or ketoconazole or other inhibi- Tablets: 250 mg.
tors of the CYP3A4 system mayqblood NURSING IMPLICATIONS
levels and the risk QTc prolongation and
serious cardiovascular adverse reactions Assessment
(avoid concurrent use and do not use ha- Assess patient for improvement in signs
lofantrine for 15 wks following last dose of and symptoms of malaria daily through-
mefloquine, mefloquine should not be out course of therapy.
started until 12 hr after the last dose of ha- Lab Test Considerations: Monitor
lofantrine). Concurrent use with quini- hepatic function periodically during
dine or quinine mayqrisk of seizures. prolonged prophylactic therapy.
pg 47 Plate
# 47 # 0-Composite
meningococcal group B vaccine 47

May causephematocrit and transient thereafter and to avoid breast feeding
qAST and ALT, leukopenia, and during therapy.
thrombocytopenia. Advise patient to carry a wallet card
Toxicity and Overdose: There are containing information about meflo-
no antidotes. Monitor cardiac function quine and potential side effects at all
(ECG) and neuropsychiatric status for times during therapy.
at least 24 hrs. Treat symptomatically. Evaluation/Desired Outcomes
Potential Nursing Diagnoses If no improvement within 48 to 72 hrs,
Deficient knowledge, related to medica- do not use mefloquine for retreatment.
tion regimen (Patient/Family Teaching) If mefloquine for prophylaxis failed, use
Implementation another agent for curative treatment.
PO: Administer with food, preferably af-
ter eating main meal, and at least 8 meningococcal group B
ounces of water. May be crushed and
mixed with small amount of water, vaccine
milk, or other beverage for children or (me-nin-go-kok-al groop B
others unable to swallow whole. vax-seen)
Patient/Family Teaching Bexsero, Trumenba
Instruct patient to take medication ex- Classification
actly as directed and continue full
course of therapy even if feeling better. Thera: vaccines/immuniz-
Advise patient to read Medication ing agents
Guide before starting therapy and with Pharm: antigens
each Rx refill in case of changes.
Malaria Prophylaxis: Review meth- Pregnancy Category B
ods of minimizing exposure to mosqui-
toes with patients receiving mefloquine Indications
prophylactically (use repellent, wear Bexsero Provides active immunization
long-sleeved shirt and long trousers, against invasive meningococcal disease
use screen or netting). caused by 3 strains of Neisseria meningi-
Advise patient to notify health care pro- tidis serogroup B (strains prevalent in the
fessional if fever develops while travel- US). Tremenba Provides active immu-
ing or within 2 mo of leaving an en- nization against invasive meningococcal
demic area. disease caused by 4 strains of Neisseria
Advise patient taking mefloquine for a meningitidis serogroup B (strains preva-
year of longer to have eye exams, espe- lent in the US).
cially if vision changes occur. Action
May cause dizziness and loss of bal- Induces production of antibodies to sev-
ance. Caution patient to avoid driving eral strains of serogroup B Neisseria
and other activities requiring alertness meningitidis. Therapeutic Effects:
and fine moror coordination until re- Prevention of invasive meningococcal dis-
sponse to medication is known. ease.
Advise patient to tell health care profes-
sional what medications they are taking Pharmacokinetics
and to avoid taking new Rx, OTC, vita- Absorption: Well absorbed following IM
mins, or herbal products without con- administration.
sulting health care professional. Distribution: Unknown.
Advise female patient to use effective Metabolism and Excretion: Un-
contraception during malaria prophy- known.
laxis with mefloquine and for 3 mo Half-life: Unknown.
pg 48 Plate
# 48 # 0-Composite
48 mixed pollens allergen extract

TIME/ACTION PROFILE (antibody Assess for syncope. Make patient is sit-
response) ting or lying down during and immedi-
ately following injections.
IM within 2 mo unknown unknown Potential Nursing Diagnoses
Risk for infection (Indications)
Contraindications/Precautions Implementation
Contraindicated in: Severe allergic re- IM: Shake syringe vigorously for a ho-
action to a previous dose; Latex allergy mogenous white suspension; do not use
(Bexsero tip caps contain latex). if solution has separated, discolored, or
Use Cautiously in: Geri: Safe and effec- contains particulate matter. Administer
tive use in patients 65 yr has not been 0.5 mL IM into deltoid muscle of upper
established; Lactation: Use cautiously if arm. Do not mix with other vaccines in
breast feeding; OB: Use during pregnancy same syringe.
only if clearly needed; Pedi: Safe and effec-
tive use in children 10 yr not established Patient/Family Teaching
(90% risk of fever in infants 12 mo). Explain purpose of vaccine to patient/
parent. Emphasize need for 2 doses of
Adverse Reactions/Side Effects immunization series for Bexseroor 3
CNS: fatigue, headache. GI: nausea, diar- doses for Tremenba.
rhea, vomiting. Local: injection site reac-
tions. MS: arthralgia, mylagia. Misc: al- Advise female patient to notify health
lergic reactions including ANAPHYLAXIS, care professional if pregnancy is
chills, fever, syncope. planned or suspected or if breast feed-
ing.
Interactions
Drug-Drug: Concurrent use of immu- Evaluation/Desired Outcomes
nosuppressives maypthe desired im- Prevention of invasive meningococcal
mune response. disease including meningitis.
Route/Dosage
mixed pollens allergen
Bexsero extract
IM (Adults and Children 10 25 yr): (miks-ed po-lenz a-ler-jen
Two 0.5 ml doses one mo apart.
ex-trakt)
Trumenba Oralair
IM (Adults and Children 10 25 yr):
0.5 ml followed by a second dose 2 mo Classification
later and a third dose 4 mo after the sec- Thera: allergy, cold, and
ond dose. cough remedies
Availability Pharm: immunotherapy
Suspension for IM injection (Bexsero
tip caps contain latex): 0.5 ml in pre- Pregnancy Category B
filled syringes.
Indications
NURSING IMPLICATIONS Treatment of grass pollen-induced allergic
Assessment rhinitis with/without conjunctivitis, con-
Monitor for signs and symptoms of al-
firmed by testing to be associated with the
lergic reaction (dyspnea, rash, hives, presence of pollen-specific IgE antibodies
swelling of face, lips, or throat). Keep for the following grasses: sweet vernal, or-
epinephrine, an antihistamine, and re- chard, perenniel rye, timothy and Ken-
suscitation equipment close by in the tucky Blue.
event of an anaphylactic reaction. Action
Assess for latex allergy. Bexsero tip cap Small doses of antigen produce T-cell acti-
contains latex. vation and downregulation of mucosal
pg 49 Plate
# 49 # 0-Composite
mixed pollens allergen extract 49

mast cells; additional effects includepIgE dominal pain, dyspepsia, oral hypoesthe-
production,qspecific immunoglobulin sia, oral pruritus, lip pruritus, mouth
G4 (IgG4) production and changes in in- edema, oral paraesthesia, stomatitis,
terleukin and eosinophil activity. Thera- tongue edema, tongue pruritus. Derm:
peutic Effects: Decreased symptoms urticaria. Misc: allergic reactions includ-
(rhinitis/conjunctivitis) and need for daily ing ANAPHYLAXIS/LARYNGOPHARYNGEAL RE-
medication to control symptoms. STRICTION.
Pharmacokinetics Interactions
Absorption: Allergen is absorbed and Drug-Drug: Concurrent allergen im-
processed from oral mucosa and GI tract. munotherapy mayqrisk of adverse re-
Distribution: Unknown. actions. Concurrent beta blockers may
Metabolism and Excretion: Un- presponse to bronchodilators or paren-
known. teral epinephrine if required for severe al-
Half-life: Unknown. lergic reactions to pollen extract. Alpha
blockers and beta blockers blunt the
TIME/ACTION PROFILE (decrease in beneficial effects of epinephrine which
symptoms/need for medications) may be required to treat anaphylaxis (q
ROUTE ONSET PEAK DURATION dose of epinephrine may be required).
SL 4 mo unknown maintained
Ergot alkaloids may reverse the pressor
through- effects of epinephrine. Effects of epineph-
out pol- rine may beqby tricyclic antidepres-
len sea- sants, levothyroxine, MAO inhibitors
son and some antihistamines including
chlorpheniramine and diphenhyra-
Contraindications/Precautions mine. Cardiac glycosides mayqrisk of
Contraindicated in: Severe/unstable/ adverse cardiovascular events with epine-
uncontrolled asthma; History of severe al- prine.
lergic or other reaction to sublingual im-
munotherapy; History of hypersensitivity to Route/Dosage
inactive ingredients. SL (Adults 18 65 yr): 300 IR daily,
Use Cautiously in: Oral inflammation/ started 4 mos prior to expected onset of
wounds including oral surgery/dental ex- grass pollen season, continued throughout
traction, oral lichan planus, mouth ulcers season.
or thrush (discontinue temporarily); Pa- SL (Children 10 17 yr): Day 1 100
tients who may not respond to epineph- IR, day 2 200 IR (Two 100 IR tablets),
rine/bronchodilators including those tak- day 3 and following 300 IR started 4
ing beta-blockers; OB: Use during mo prior to expected onset of grass pollen
pregnancy only if clearly needed (sys- season, continued throughout season.
temic/local adverse reactions may be Availability
poorly tolerated during pregnancy); Lac- Sublingual tablets: 100 index of reactiv-
tation: Use cautiously if breast feeding; ity (IR), 300 IR.
Pedi: Safe and effective use in children
10 yr has not been established. NURSING IMPLICATIONS
Exercise Extreme Caution in: Any Assessment
medical condition that may preclude sur- Assess for signs and symptoms of al-
viving a serious allergic reaction. lergy (sneezing; runny or itchy nose;
Adverse Reactions/Side Effects nasal congestion; itchy, watery eyes) be-
EENT: throat irritation, ear pruritus, oro-
fore and periodically during therapy.
pharyngeal pain, pharyngeal edema. Monitor for signs and symptoms of al-
Resp: asthma, cough, dysphonia. GI: ab- lergic reactions (trouble breathing,
pg 50 Plate
# 50 # 0-Composite
50 netupitant/palonosetron
throat tightness or swelling, trouble doses. If more than 1 dose is missed,
swallowing or speaking, dizziness or notify health care professional before
fainting, rapid or weak heartbeat, se- restarting. Explain to patient that ther-
vere stomach cramps or pain, vomiting, apy does not give immediate relief of al-
diarrhea, severe flushing or itching) for lergy symptoms. Instruct patient to read
at least 30 min after initial dose. Keep Medication Guide before starting ther-
epinephrine, an antihistamine, and re- apy and with each Rx refill in case of
suscitation equipment close by in the changes.
event of an anaphylactic reaction. Dis- Instruct patient in how and when to use
continue therapy of severe allergic re- autoinjectable epinephrine and to seek
action occurs. If persistent or escalating immediate medical care if used.
reactions occur, re-evaluate therapy Advise patient to stop therapy notify
and consider discontinuation. health care professional if signs and
Monitor for signs and symptoms of eo- symptoms of allergic reactions, asthma
sinophilic esophagitis (severe or per- attack, oral inflammation, or eosino-
sistent gastro-esophageal symptoms, philic esophagitis occur.
dysphagia, chest pain). Discontinue Instruct patient to notify health care
therapy and consider diagnosis if symp- professional of all Rx or OTC medica-
toms occur. tions, vitamins, or herbal products be-
Monitor for signs and symptoms of ing taken and to consult health care
asthma attack (wheezing, coughing, professional before taking other Rx,
dyspnea) before administering. With- OTC, or herbal products.
hold if patient experiencing acute Advise female patient to notify health
asthma exacerbation. If recurrent care professional if pregnancy is
asthma exacerbations occur, consider planned or suspected or if breast feed-
discontinuation of therapy. ing.
Assess for oral inflammation (oral li-
chen planus, mouth ulcers, thrush) Decreased symptoms or allergic rhinitis
prior to administration. Allow healing
and/or conjunctivitis.
before administration.
Ineffective breathing pattern (Indications) netupitant/palonosetron
Implementation (ne-too-pi-tant/pa-lone-o-
Therapy should be started at least 4 mo se-tron)
prior to onset and throughout grass Akynzeo
pollen season. Administer first dose in
health care setting and monitor patient
Classification
for allergic reactions for at least 30 min. Thera: antiemetics
If no reactions occur, patient may ad- Pharm: neurokinin antago-
minister subsequent doses at home. nists, 5-HT3 antagonists
SL: Remove tablet from blister just
prior to dosing. Immediately place tab- Pregnancy Category C
let under tongue until complete dissolu-
tion for at least 1 min before swallow- Indications
ing. Wash hands after handling tablet. Treatment of acute and delayed nausea
Patient/Family Teaching and vomiting associated with chemother-
Instruct patient in correct method of
apy including highly emetogenic chemo-
taking Oralair; avoid swallowing tablet therapy.
until dissolved. Avoid food or beverage Action
for 5 min after dissolution of tablet. If Netupitant Acts as a selective antago-
dose is missed, omit and take next nist at substance P/neurokinin 1 (NK1)
scheduled dose next day; do not double receptors in the CNS; prevents nausea and
pg 51 Plate
# 51 # 0-Composite
netupitant/palonosetron 51
vomiting in the acute and delayed phases use in children 18 yr has not been estab-
after chemotherapy. Palonosetron lished.
Blocks the effects of serotonin at receptor Adverse Reactions/Side Effects
sites (selective antagonist) located in vagal CNS: fatigue, headache, weakness. GI:
nerve terminals and in the chemoreceptor constipation, dyspepsia. Derm: erythema.
trigger zones in the CNS; prevents nausea Misc: hypersensitivity reactions including
and vomiting in the acute phase. Thera- ANAPHYLAXIS, SEROTONIN SYNDROME.
peutic Effects: Decreased incidence
and severity of nausea and vomiting fol- Interactions
lowing emetogenic chemotherapy. Drug-Drug: Netupitant is a long-lasting
inhibitor of CYP3A4 and canqlevels of
Pharmacokinetics drugs that are CYP3A4 substrates in-
Netupitant cluding alprazolam, cyclophospha-
Absorption: Absorption follows oral ad- mide, dexamethasone, docetaxel, eto-
ministration. poside, ifosfamide, imatinib,
Distribution: Unknown. irinotecan, midazolam, paclitaxel,
Protein Binding: 99.5%. triazolam, vinorelbine, vinblastine,
Metabolism and Excretion: Exten- and vincristine for 4 days or more; con-
sively metabolized, three metabolites have current use should be undertaken with
anti-emetic activity, 1% excreted un- caution and necessary dose adjustments
changed in urine. made. Inducers of CYP3A4 including
Half-life: 80 hr. rifampin mayplevels and effectiveness;
Palonosetron concurrent use should be avoided. Con-
Absorption: 97% absorbed following current use of other serotonergic
oral administration. drugs mayqrisk of serotonin syndrome.
Distribution: Unknown. Route/Dosage
Metabolism and Excretion: 50% me- PO (Adults): Highly emetogenic
tabolized (mostly by CYP2D6); 40% ex- chemotherapy (included cisplatin-
creted unchanged in urine. based) One capsule (netupitant 300
Half-life: 40 hr. mg/palonosetron 0.5 mg) one hr before
TIME/ACTION PROFILE chemotherapy on day 1. Anthracycline
and cyclophosphamide based chemo-
ROUTE ONSET PEAK DURATION therapy and other chemotherapy not
netupitant 15 min-3 hr 5 hr days considered highly emetogenic One
PO capsule (netupitant 300 mg/palonosetron
palonose- within 1 hr 5 hr days 0.5 mg) one hr before chemotherapy.
tron PO
Availability
Contraindications/Precautions Capsules: netupitant 300 mg/palonose-
Contraindicated in: Severe/end stage tron 0.5 mg.
hepatic or renal impairment; Cross-sensi-
tivity may occur with other 5 HT3 antago-
nists; Lactation: Discontinue netupitant/ Assessment
palonosetron or discontinue breast feed- Assess patient for nausea, vomiting, ab-
ing. dominal distention, and bowel sounds
Use Cautiously in: Geri: Consider age- prior to and following administration.
related decrease in renal, hepatic and car- Assess for serotonin syndrome (mental
diac function, concurrent disease states changes [agitation, hallucinations, de-
and drug therapies; OB: Use during preg- lirium, coma], autonomic instability
nancy only if potential benefit justifies po- [tachycardia, labile BP, dizziness, dia-
tential fetal risk; Pedi: Safe and effective phoresis, flushing, hyperthermia], neu-
pg 52 Plate
# 52 # 0-Composite
52 nintedanib
romuscular aberrations [tremor, rigid-
ity, myoclonus, hyperreflexia, nintedanib
incoordination], seizure, and/or GI (nin-ted-a-nib)
symptoms [nausea, vomiting, diar- Ofev
rhea]), especially in patients taking
other serotonergic drugs (SSRIs, SNRIs, Classification
triptans). Thera: agents for pulmo-
Lab Test Considerations: May nary fibrosis
cause transientqin serum bilirubin, Pharm: kinase inhibitors
AST, and ALT levels.
Potential Nursing Diagnoses Pregnancy Category D
Imbalanced nutrition: less than body re-
quirements (Indications) Indications
Treatment of idiopathic pulmonary fibro-
Implementation sis (IPF).
For highly emetogenic chemotherapy, Action
administer with dexamethasone PO 12 Inhibits tyrosine kinases which may be re-
mg 30 min prior to chemotherapy on sponsible for proliferation, migration and
day 1 and 8 mg PO on days 2 and 4. For transformation of fibroblasts in pulmonary
chemotherapy not considered highly fibrosis. Therapeutic Effects: Slowed
emetogenic, administer dexametha- progression of pulmonary impairment in
sone 30 min prior to chemotherapy on pulmonary fibrosis.
Day 1 (day 2 and 4 not needed).
PO: Administer netupitant/palonose- Pharmacokinetics
tron 1 hr prior to start of chemotherapy Absorption: 4.7% absorbed following
without regard to food. oral administration (substantial first-pass
effect).
Patient/Family Teaching Distribution: Unknown.
Instruct patient to take netupitant/pa- Protein Binding: 97.8%.
lonsetron as directed. Advise patient to Metabolism and Excretion: Under-
reach Patient Information prior to goes extensive metabolism and subse-
starting therapy and with each Rx refill quent fecal/biliary elimination (93.4%).
in case of changes. Minimal amounts excreted in urine.
Advise patient to notify health care pro- Half-life: 9.5 hr.
fessional promptly if signs and symp-
toms of anaphylaxis (shortness or
TIME/ACTION PROFILE (effects on
breath, rash, hives, swelling of mouth, pulmonary function)
throat, and lips) or serotonin syndrome ROUTE ONSET PEAK DURATION
occur. PO 46 wk 36 wk unknown
care professional if pregnancy is Contraindications/Precautions
planned or suspected or if breast feed- Contraindicated in: Lactation: Discon-
ing. tinue nintedanib or discontinue breast
feeding; Moderate to severe hepatic im-
Evaluation/Desired Outcomes pairment; OB: Pregnancy (can cause fetal
Decrease in frequency and severity of harm).
nausea and vomiting. Use Cautiously in: Recent GI surgery
or other risk of GI perforation (mayq
risk, use only if expected benefit out-
weighs potential risk); Known cardiovas-
cular risk factors including coronary ar-
tery disease; Female patients with
child-bearing potential (effective contra-
pg 53 Plate
# 53 # 0-Composite
nintedanib 53
ception should be used); Cigarette smok- NURSING IMPLICATIONS
ing (mayplevels and effectiveness); Se-
vere renal impairment/end-stage renal Assessment
disease (safe and effective use not estab- Monitor for signs and symptoms of pul-
lished); Pedi: Safe and effective use in monary fibrosis (dyspnea, decreased
children has not been established. forced vital capacity (FVC), diffuse pul-
monary infiltrates on chest x-ray) dur-
Adverse Reactions/Side Effects ing therapy.
CNS: headache. CV: ARTERIAL THROMBEM- Monitor for diarrhea, nausea and vom-
BOLIC EVENTS INCLUDING MYOCARDIAL IN- iting during therapy. Diarrhea usually
FARCTION, hypertension. GI: GASTROINTES- occurs during first 3 mo. Treat diar-
TINAL PERFORATION, abdominal pain,p rhea, nausea and vomiting with ade-
appetite, diarrhea,qliver enzymes, nau- quate hydration and antidiarrheal (lop-
sea, vomiting,pweight. Endo: hypthy- eramide) and antiemetic medications.
roidism. Hemat: BLEEDING. Consider interruption of therapy if diar-
rhea or nausea and vomiting continues.
Interactions Therapy may be resumed at full dose or
Drug-Drug: Concurrent use of oral P- at reduced dose and increased to full
gp and CYP3A4 inhibitors including dose. Discontinue therapy if diarrhea,
erythromycin and ketoconazoleq nausea, and vomiting is severe and per-
blood levels and the risk of adverse reac- sists despite symptomatic therapy.
tions; close monitoring is recommended. Lab Test Considerations: Obtain
Concurrent use of oral P-gp and liver function tests prior to starting ther-
CYP3A4 inducers including carbama- apy, moly for 3 mo, every 3 mo thereaf-
zepine, phenytoin and rifampinp ter, and as clinically indicated. If AST or
blood levels and maypeffectiveness; con- ALTq3 times to 5 times upper limit
current use should be avoided. Cigarette of normal without signs of liver damage,
smokingpblood levels and maypeffec- interrupt therapy or reduce dose to 100
tiveness, encourage cessation prior to mg twice daily. Once liver enzymes have
treatment. Anticoagulants and anti- returned to baseline, may reintroduce
platelet agents mayqrisk of bleeding. nintedanib at a reduced dose (100 mg
Drug-Natural Products: St. Johns twice daily), which may increase to full
wortpblood levels and maypeffective- dose (150 mg twice daily). Discontinue
ness; concurrent use should be avoided. nintedanib if AST or ALTq5 times up-
per limit of normal or 3 times upper
Route/Dosage limit of normal with signs and symp-
PO (Adults): 150 mg twice daily; may be toms of liver damage.
pto 100 mg twice daily if adverse reac- Potential Nursing Diagnoses
tions occur. Ineffective breathing pattern (Indications)
Hepatic Impairment Implementation
PO (Adults): AST or ALT 3 times to 5 PO: Administer with food and liquid
times upper limit of normal without once every 12 hrs. Swallow capsule
signs of severe liver damage tempo- whole; do not open, crush, or chew,
rarily discontinue orpdose to 100 mg contents taste bitter.
twice daily; may be resumed or doseqto Patient/Family Teaching
150 mg twice daily when enzymes have re- Instruct patient to take nintedanib as di-
turned to baseline. rected. If a dose is missed, omit and
take next dose at scheduled time; do
Availability not double doses. Advise patient to read
Capsules: 100 mg, 150 mg. Patient Information sheet prior to
pg 54 Plate
# 54 # 0-Composite
54 nivolumab
starting therapy and with each Rx refill
in case of changes. nivolumab
Advise patient that diarrhea nausea, and ( nye-vol-ue-mab)
vomiting are common side effects and Opdivo
advise to maintain hydration and take
antidiarrheal or antiemetic medication Classification
as needed. Notify health care profes- Thera: antineoplastics
sional if diarrhea, nausea, or vomiting Pharm: antibody
is persistent or severe.
Encourage patient to stop smoking be- Pregnancy Category UK
fore therapy and to avoid smoking dur-
ing therapy. Indications
Advise patient to notify health care pro- Treatment of progressive unresectable/
fessional immediately if signs and symp- metastatic melanoma previously treated
toms of liver dysfunction (skin or with ipilimumab and if BRAF V600 muta-
whites or eyes turn yellow, urine turns tion positive, a BRAF inhibitor.
dark or brown (tea colored), pain on Action
right side of stomach, unusual bleeding Acts as a human programmed death re-
or bruising, lethargy), arterial throm- ceptor-1 (PD-1) blocking antibody. Inhib-
botic events such as heart attack (chest its T-cell proliferation and cytokine pro-
pain or pressure; pain in arms, back, duction. Therapeutic Effects:
neck, or jaw; shortness of breath) or Decreased spread of melanoma.
stroke (Numbness or weakness on 1
side of body, trouble talking, headache, Pharmacokinetics
dizziness), or gastric perforation (pain Absorption: IV administration results in
or swelling in stomach area), occur. complete bioavailability.
Advise patient to notify health care pro- Distribution: Unknown.
fessional of all Rx or OTC medications, Metabolism and Excretion: Un-
vitamins, or herbal products being known.
taken and to consult with health care Half-life: 26.7 days.
professional before taking other medi- TIME/ACTION PROFILE
cations.
Caution female patient that nintedanib is ROUTE ONSET PEAK DURATION
teratogenic. Advise patient to use ade- IV unknown unknown unknown
quate contraception during and for at
least 3 mo following therapy. Notify Contraindications/Precautions
health care professional if pregnancy is Contraindicated in: OB: Pregnancy
suspected or planned. Avoid breast (may cause fetal harm); Lactation: Dis-
feeding during therapy. continue breast feeding.
Emphasize the importance of follow up Use Cautiously in: Pedi: Safe and effec-
blood tests to determine liver function. tive use in children has not been estab-
Evaluation/Desired Outcomes lished.
Decrease in rate of decline in forced vi- Adverse Reactions/Side Effects
tal capacity (FVC) and extension in time Resp: IMMUNE-MEDIATED PNEUMONITIS,
to first exacerbation of pulmonary fi- cough. CV: peripheral edema. GI: IM-
brosis. MUNE-MEDIATED COLITIS, immune-medi-
ated hepatitis. GU: immune-mediated ne-
phritis/renal dysfunction. Derm: rash.
Endo: immune-mediated hyper/hypothy-
roidism. F and E: hyperkalemia.
Interactions
Drug-Drug: None noted.
pg 55 Plate
# 55 # 0-Composite
nivolumab 55
Route/Dosage day prednisone equivalents for Grade
IV (Adults): 3 mg/kg every two weeks, 2 transaminaseq, with or withoutqin
immune-mediated adverse reactions may total bilirubin. Withhold for moderate
require dose modification/discontinua- (Grade 2) and permanently discontinue
tion). for severe (Grade 3) or life-threatening
Availability (Grade 4) immune-mediated hepatitis.
Solution for intravenous use: 40 mg/4 Monitor forqserum creatinine prior to
mL single-use vial, 100 mg/10 mL single- and periodically during therapy. Admin-
use vial. ister corticosteroids at a dose of 1 2
mg/kg/day prednisone equivalents fol-
NURSING IMPLICATIONS lowed by corticosteroid taper for life-
threatening (Grade 4)qserum creati-
Assessment nine and permanently discontinue
Monitor for signs and symptoms of im- nivolumab. Withhold nivolumab for se-
mune-mediated pneumonitis (short- vere (Grade 3) or moderate (Grade 2)
ness of breath, chest pain, new or qserum creatinine and administer
worse cough) periodically during ther- corticosteroids at a dose of 0.5 1 mg/
apy. Treat with corticosteroids 1 2 mg/ kg/day prednisone equivalents followed
kg/day prednisone equivalents for by corticosteroid taper. If worsening or
Grade 2 pneumonitis followed by cor- no improvement occurs, increase dose
ticosteroid taper. Withhold nivolumab of corticosteroids to 1 2 mg/kg/day
and monitor symptoms for moderate prednisolone equivalents and perma-
(Grade 2) pneumonitis; resume therapy nently discontinue nivolumab.
when recovery to Grade 0 to 1. Perma- Monitor thyroid function prior to and
nently discontinue for severe (Grade 3) periodically during therapy. Treat hypo-
or life-threatening (Grade 4) pneumo- thyroidism with replacement therapy.
nitis. Use medical management for hyperthy-
Monitor for signs and symptoms of im- roidism. Immune-mediated thyroid dys-
mune-mediated colitis (diarrhea, ab- function does not require dose modifi-
dominal pain, mucus or blood in stool, cation of nivolumab.
with or without fever). Treat with corti-
costeroids at doses of 1 2 mg/kg/day Potential Nursing Diagnoses
of prednisone or equivalents followed Diarrhea (Adverse Reactions)
by corticosteroid taper for severe Deficient knowledge, related to medica-
(Grade 3) or life-threatening (Grade 4) tion regimen (Patient/Family Teaching)
colitis. Treat with corticosteroids at a Implementation
dose of 0.5 mg/kg/day of prednisone or
IV Administration
equivalent followed by corticosteroid
taper for moderate (Grade 2) colitis or Intermittent Infusion: Diluent:
5 days; if worsening or no improve- 0.9% NaCl or D5W. Concentration: 1
ment despite corticosteroids increase mg/mL to 10 mg/mL. Mix by gentle in-
dose to 1 2 mg/kg/day prednisone version; do not shake. Solution is clear
equivalents. Withhold nivolumab for to slightly opalescent, colorless to
Grade 2 or 3 colitis; permanently dis- slightly yellow; do not administer solu-
continue nivolumab for Grade 4 colitis tion if discolored or contains particu-
or for recurrent colitis upon restarting late matter other than translucent to
nivolumab. white proteinaceous particles. Solution
Lab Test Considerations: Monitor is stable at room temperature for up to
for abnormal liver tests prior to and pe- 4 hr and 24 hr if refrigerated. Rate: In-
riodically during therapy. Administer fuse through a sterile, non-pyrogenic,
corticosteroids at dose of 1 2 mg/kg/ low-protein binding 0.2 micrometer to
pg 56 Plate
# 1 # 0-Composite
56 olaparib
1.2 micrometer in-line filter over 60 tated advanced ovarian cancer following
min. Flush line at end of infusion. three previous lines of chemotherapy.
Y-Site Incompatibility: Do not ad- Action
minister other drugs through same infu- Acts as a poly (ADP-ribose) polymerase
sion line. (PARP) inibitor; disrupts DNA transcrip-
Patient/Family Teaching tion, cell cycle regulation and DNA repair.
Explain purpose of nivolumab to pa- Therapeutic Effects: Decreased
tient. growth and spread of ovarian cancer.
Advise patient to notify health care pro- Pharmacokinetics
fessional immediately if signs and symp- Absorption: Well absorbed following
toms of pneumonitis, colitis, hepatitis oral administration.
(jaundice, severe nausea or vomiting, Distribution: Unknown.
pain on right side of abdomen, lethargy,
easy bruising or bleeding), kidney
Metabolism and Excretion: Exten-
problems (decreased urine output, sively metabolized (mostly by CYP3A en-
blood in urine, swollen ankles, loss of zyme system); 15% excreted unchanged in
appetite), hormone gland problems urine, 6% in feces.
(rapid heart beat, weight loss, in- Half-life: 11.9 hr.
creased sweating, weight gain, hair loss, TIME/ACTION PROFILE (blood
feeling cold, constipation, deepening of levels)
voice, muscle aches, dizziness or faint-
ing, persistent or unusual headache) ROUTE ONSET PEAK DURATION
occur. PO unknown 13 hr 12 hr
Instruct patient to notify health care Median duration of tumor response 7.9 mo.
tions, vitamins, or herbal products be- Contraindications/Precautions
ing taken and to consult with health Contraindicated in: OB: May cause fe-
care professional before taking other tal harm; Lactation: Discontinue olaparib
medications. or discontinue breast feeding.
Advise female patient of reproductive Use Cautiously in: Concurrent use of
potential to use highly effective contra- strong/moderate CYP3A inhibitors (avoid
ception during and for 5 mo after last if possible, if concurrent use is necessary
dose; may cause fetal harm. Avoid polaparib dose); Concurrent use of
breast feeding during therapy. strong/moderate CYP3A inducers (avoid if
Emphasize importance of keeping possible, if concurrent use is necessary ef-
scheduled appointments for blood fectiveness of olaparib may bep); Hepatic
work or other laboratory tests. impairment; Renal impairment (CCr 50
Evaluation/Desired Outcomes mL/min); Pedi: Safe and effective use in
pspread of melanoma. children has not been established.
Adverse Reactions/Side Effects
olaparib (oh-lap-a-rib) CNS: fatigue, headache, weakness. Resp:
PNEUMONITIS, cough. GI: abdominal pain,
Lynparza pappetite, diarrhea, dyspepsia, nausea,
Classification vomiting, dysgeusia. Derm: dermatitis/
rash. Hemat: MYELODYSPLASTIC SYN-
Thera: antineoplastics DROME/ACUTE MYELOID LEUKEMIA, anemia,
Pharm: enzyme inhibitors lymphopenia, neutropenia, thrombocyto-
Pregnancy Category D penia. MS: arthralgia, back pain, muscu-
loskeletal pain, myalgia.
Indications Interactions
Treatment of deleterious/suspected dele- Drug-Drug:qrisk of prolonged myelo-
terious documented germline BRCA mu- suppression with other antineoplastics.
pg 57 Plate
# 57 # 0-Composite
olaparib 57
Concurrent use with strong/moderate has recovered from hematological tox-
CYP3A inhibitors including amprenavir, icities from previous chemotherapy
aprepitant, atazanavir, boceprevir, (CTCAE Grade 1). For prolonged
ciprofloxacin, clarithromycin, crizoti- hematological toxicities, interrupt ola-
nib, darunavir/ritonavir, diltiazem, parib and monitor CBC weekly until re-
erythromycin, fluconazole, fosam- covery. If levels have not recovered to
prenavir, imatinib, indinavir, itracon- Grade 1 after 4 wks, refer to hematol-
azole, ketoconazole, lopinavir/rito- ogist. Discontinue olaparib if myelodys-
navir, nefazodone, nelfinavir, plastic syndrome or acute myeloid leu-
posaconazole, ritonavir, saquinavir, kemia is confirmed.
telaprevir, telithromycin, verapamil May causephemoglobin, neutrophils,
and voriconazoleqblood levels and the platelets, and lymphocytes. May cause
risk of toxicity (avoid concurrent use if qmean corpuscular volume and creat-
possible but if necessary olaparib dose inine.
should bep). Concurrent use with strong Potential Nursing Diagnoses
CYP3A inducers including carbamaze- Nausea (Side Effects)
pine, phenytoin, and rifampicinp Risk for infection (Adverse Reactions)
blood levels and effectiveness and should
be avoided. Concurrent use with moder- Implementation
ate CYP3A inducers including bosen- PO: Take eight 50 mg capsules twice
tan, efavirenz, etravirine, modafinil daily (800 mg/day). Swallow capsules
and nafcillinpblood levels and effective- whole; do not open, chew, or dissolve
ness; avoid if possible. capsule; do not take capsules that are
Drug-Natural Products: St. Johns deformed or leak.
wort maypblood levels and effectiveness If dose reduction is needed, reduce
and should be avoided. dose to 200 mg (four 50 mg capsules)
Drug-Food: Concurrent ingestion of twice daily or 400 mg/day. If further fi-
grapefruit and Seville oranges mayq nal dose reduction is needed, reduce to
blood levels and the risk of toxicity and 100 mg (two 50 mg capsules) twice
should be avoided. daily or 200 mg.
Route/Dosage Patient/Family Teaching
PO (Adults): 400 mg twice daily contin- Instruct patient to take olaparib as di-
ued until disease progression or unac- rected. If a dose is missed, do not take
ceptable toxicity; dose disruption/reduc- another to make up; omit dose and take
tion may be required. next scheduled dose.
Inform patient that mild to moderate
Availability nausea and/or vomiting is common
Capsules: 50 mg. when taking olaparib. Notify health care
NURSING IMPLICATIONS professional for antiemetic options if
this is problematic.
Assessment Advise patient to avoid grapefruit or Se-
Monitor for signs and symptoms of ville oranges during therapy.
pneumonitis (new or worsening respi- Advise patient to notify health care pro-
ratory symptoms, dyspnea, fever, fessional if signs and symptoms of
cough, wheezing, radiological abnor- pneumonitis or hematological toxicity
mality) during therapy. Interrupt ther- (weakness, feeling tired, fever, weight
apy; if pneumonitis confirmed, discon- loss, frequent infections, bruising,
tinue therapy. bleeding easily, shortness of breath,
Lab Test Considerations: Monitor blood in urine or stool, low blood cell
CBC at baseline and moly during ther- counts on laboratory findings, need for
apy. Do not start olaparib until patient blood transfusions). May also be mye-
pg 58 Plate
# 1 # 0-Composite
58 olodaterol
lodysplastic syndrome (MDS) or acute Metabolism and Excretion: Exten-
myeloid leukemia (AML). sively metabolized (some by CYP 3A4),
Instruct patient to notify health care only one metabolite binds to B2adrenergic
professional of all Rx or OTC medica- receptors. Following inhalation, 5 7%
tions, vitamins, or herbal products be- excreted unchanged in urine, remainder
ing taken and to consult with health in feces as drug and metabolites (84%).
care professional before taking other Half-life: 45 hr (following inhalation).
medications.
Inform female patient that olaparib is TIME/ACTION PROFILE (improvement
teratogenic and to use effective contrain FEV1)
ception during and for at least 1 mo af- ROUTE ONSET PEAK DURATION
ter last dose. Advise patient to notify inhaln within 1 hr 15 hr 24 hr
health care professional if pregnancy is
planned or suspected. Advise patient to Contraindications/Precautions
avoid breast feeding during therapy. Contraindicated in: Severe/acute/dete-
Emphasize importance of lab test to riorating symptoms of airflow obstruction.
monitor for side effects. Use Cautiously in: History of seizures;
Evaluation/Desired Outcomes Thyrotoxicosis; History of cardiovascular
Decreased growth and spread of ovar- disorders (coronary insufficiency, ar-
ian cancer. rhythmias, hypertension); Sensitivity to
sympathomimetics (adrenergics); Severe
hepatic impairment; OB: Use during preg-
olodaterol nancy only if potential benefit justifies po-
(oh-loh-dat-er-ole) tential risk to the fetus; Lactation: Use cau-
Striverdi tiously if breast feeding (probably enters
breast milk); Pedi: Safe and effective use
Classification in children has not been established.
Thera: bronchodilators Exercise Extreme Caution in: Con-
Pharm: beta-adrenergic current use with MAOIs, tricyclic antide-
agonists pressants or drugs that prolong QTc (q
risk of adverse cardiovascular reactions).
Pregnancy Category C Adverse Reactions/Side Effects
CNS: dizziness. EENT: nasopharyngitis.
Indications Resp: PARADOXICAL BRONCHOSPASM,
Maintenance treatment of airflow obstruc- cough. CV:qBP, ECG changes, tachycar-
tion in patients with COPD including dia. GI: diarrhea. Endo: hyperglycemia.
chronic bronchitis and emphysema. F and E: hypokalemia. MS: arthralgia,
Action back pain. Misc: hypersensitivity reac-
A long-acting beta2-adrenergic agonist tions including ANGIOEDEMA.
(LABA) that stimulates adenyl cyclase, re- Interactions
sulting in accumulation of cyclic adeno- Drug-Drug: Concurrent use with
sine monophosphate (cAMP) at beta2- MAOIs, tricyclic antidepressants, or
adrenergic receptors resulting in drugs that prolong QTcqrisk of ad-
bronchodilation. Therapeutic Effects: verse cardiovascular reactions (use with
Bronchodilation with decreased airflow extreme caution). Concurrent use of other
obstruction. adrenergicsqrisk of adverse adrenergic
Pharmacokinetics adverse reactions (tachycardia,qblood
Absorption: 30% absorbed following pressure). Concurrent use with cortico-
oral inhalation (from lung surface); swal- steroids, non-potassium sparing diu-
lowed drug is minimally absorbed. retics, or xanthine derivatives (includ-
Distribution: Extensive tissue distribu- ing theophylline) mayqrisk of
tion; probably enters breast milk. hypokalemia and adverse cardiovascular
pg 59 Plate
# 59 # 0-Composite
olodaterol 59
reactions (use cautiously). Concurrent Use once (2 puffs), at the same time
use with beta blockers maypeffective- daily.
ness and cause severe bronchospasm (use A rescue inhaler of short-acting beta2-
cautiously). Should not be used concur- agonists should always be available to
rently with any other long-acting beta2- treat sudden bronchospasm.
adrenergic blockers (LABAs). Blood Patient/Family Teaching
levels may beqby ketoconazole. Instruct patient in the correct use of
Route/Dosage Striverdi Respimat. Take missed doses
Inhaln (Adults): 2 inhalations once as soon as remembered. Do not take
daily. more than 1 dose (2 puffs) in 24 hr.
Availability Advise patient not to discontinue with-
Inhalation spray: 2.7 mcg (delivers 2.5 out consulting health care professional;
mcg) per actuation in cartridges contain- symptoms may recur.
ing 14 doses/cartridge (one actuation lost Inform patient that olodaterol is not an
in priming) for use with Respimat inhaler. rapid-actinga long-acting bronchodila-
tor and should not be used for treating
NURSING IMPLICATIONS sudden breathing problems.
Assessment fessional if signs and symptoms of aller-
Assess respiratory status (rate, breath gic reaction, worsening symptoms; de-
sounds, degree of dyspnea, pulse) be- creasing effectiveness of inhaled,
fore administration and at peak of med- short-acting beta2 agonists; need for
ication. Consult health care professional more inhalations than usual of inhaled,
about alternative medication if severe short-acting beta2-agonists; or signifi-
bronchospasm is present; onset of ac- cant decrease in lung function occur.
tion is too slow for patients in acute dis- Instruct patient to notify health care
tress. If paradoxical bronchospasm professional of all Rx or OTC medica-
(wheezing) occurs, withhold medications, vitamins, or herbal products be-
tion and notify health care professional ing taken and to avoid concurrent use
immediately. of Rx, OTC, and herbal products with-
Monitor for signs and symptoms of al- out consulting health care professional.
lergic reactions (difficulties in Advise female patient to notify health
breathing or swallowing, swelling of care professional if pregnancy is
tongue, lips and face, urticaria, skin planned or suspected or if breast feed-
rash). Discontinue therapy if symptoms ing.
occur.
Lab Test Considerations: May Evaluation/Desired Outcomes
cause transient hypokalemia and hyper- Bronchodilation with decreased airflow
glycemia. obstruction.
Ineffective airway clearance (Indications)
Risk for activity intolerance (Indications)
Implementation
Inhaln: Prior to first use, prime the in-
haler by actuating toward ground until
aerosol cloud is visible, then repeat
procedure 3 more times. If not used for
3 days, actuate inhaler once to prepare
for use. Striverdi Respimat has a slow-
moving mist to assist with inhalation.
pg 60 Plate
# 60 # 0-Composite
60 oritavancin
rin (qrisk of bleeding, use only if benefit
oritavancin outweighs bleeding risk); Confirmed/sus-
(oh-rit-a-van-sin) pected osteomyelitis (alternate treatment
Orbactiv required).
Use Cautiously in: Concurrent use of
Classification drugs with narrow therapeutic indices that
Thera: anti-infectives are metabolized by the CYP450 enzyme
Pharm: lipoglycopeptides system (effects may be altered); Severe
hepatic/renal impairment; Geri: Elderly
Pregnancy Category C patients may beqsensitive to drug effects;
OB: Use during pregnancy only if potential
Indications benefit justifies fetal risk; Lactation: Use
Treatment of acute bacterial skin and skin cautiously if breast feeding; Pedi: Safe and
structure infections caused by or sus- effective use in patients 18 yr has not
pected to be caused by susceptible desig- been established.
nated Gram-positive bacteria. Adverse Reactions/Side Effects
Action CNS: headache. CV: tachycardia. GI: di-
Binds to bacterial cell wall resulting in cell arrhea including CLOSTRIDIUM DIFFICILE,
death. Therapeutic Effects: Bacteri- qliver enzymes, nausea, vomiting. Lo-
cidal action against susceptible bacteria cal: infusion site reactions. Misc: hyper-
with resolution of infection. Spectrum: sensitivity reactions including ANAPHYLAXIS,
Active against Staphylococcus aureus (in- infusion reactions including Red-Man
cluding methicillin-susceptible and resis- Syndrome, limb/subcutaneous abscess
tant strains), Streptococcus pyogenes, formation.
Streptococcus agalactiae, Streptococcus
dysgalactiae, Streptococcus anginosus Interactions
(including S. anginosus, S. intermidius Drug-Drug:qrisk of bleeding with
and S. constellatus) and Enterococcus warfarin (avoid if possible). Affects the
faecalis (vancomycin-susceptible strains activities of several CYP450 enzymes
only). (careful monitoring of other drugs me-
tabolized by the CYP450 system that
Pharmacokinetics have narrow therapeutic indices to assess
Absorption: IV administration results in for toxicity or ineffectiveness is recom-
complete bioavailability. mended).
Distribution: Penetrates skin/skin
structures. Route/Dosage
Metabolism and Excretion: Slowly IV (Adults 18 yr): 1200 mg single
excreted unchanged in urine (5% in two dose.
weeks) and feces (1% in two weeks). Availability
Half-life: 245 hr (terminal). Lyophylized powder for intravenous
TIME/ACTION PROFILE (blood administration (requires reconstitu-
levels) tion) : 400 mg/vial.
ROUTE ONSET PEAK DURATION NURSING IMPLICATIONS
IV rapid end of in- at least 2 wk
fusion
Assessment
Assess for infection (vital signs; appear-
Contraindications/Precautions ance of wound, sputum, urine, and
Contraindicated in: Hypersensitivity stool; WBC) at beginning of and during
(cross-sensitivity with other glycopeptides therapy.
may occur); Heparin use within 48 hr fol- Obtain specimens for culture and sensi-
lowing administration of oritavancin tivity prior to therapy. First dose may be
(causes falseqaPTT); Concurrent warfa- given before receiving results.
pg 61 Plate
# 1 # 0-Composite
palbociclib 61
Monitor bowel function. Diarrhea, ab- hypersensitivity reactions (rash, hives,
dominal cramping, fever, and bloody dyspnea, facial swelling) occur.
stools should be reported to health care Instruct patient to notify health care
professional promptly as a sign of pseu- professional immediately if diarrhea,
domembranous colitis. May begin up to abdominal cramping, fever, or bloody
2 mo following cessation of therapy. stools occur and not to treat with antidi-
Monitor for infusion reactions (Red- arrheals without consulting health care
man syndrome flushing of upper professionals.
body, urticaria, pruritus, rash). May re- Advise patient to notify health care pro-
solve with stopping or slowing infusion. fessional of all Rx or OTC medications,
Lab Test Considerations: Monitor vitamins, or herbal products being
hepatic function tests. May causeqALT, taken and to consult with health care
AST, and bilirubin. professional before taking other medi-
May cause hyperuricemia and hypogly- cations.
cemia. Advise female patients to notify health
Causes falselyqaPTT for 48 hr after in- care professional if pregnancy is
fusion. Avoid heparin administration planned or suspected or if breast feed-
during this time. Use a non-phospho- ing.
lipid dependent coagulation test such as Instruct the patient to notify health care
Factor Xa assay if needed. professional if symptoms do not im-
Artificially prolongs PT and INR for up prove.
to 24 hr. May increase risk of bleeding
with warfarin. Evaluation/Desired Outcomes
Resolution of the signs and symptoms of
Potential Nursing Diagnoses infection. Length of time for complete
Risk for infection (Indications) resolution depends on the organism
Diarrhea (Adverse Reactions) and site of infection.
Implementation
Using three 400 mg vials, add 40 mL of
palbociclib
Sterile Water for Injection to each vial
for a 10 mg/mL solution/vial. Swirl gen- (pal-bo-si-klib)
tly to avoid foaming and ensure powder Ibrance
is completely reconstituted. Solution is Classification
clear and colorless to pale yellow; do
not administer solutions that are discol- Thera: antineoplastics
ored or contain particulate matter. Pharm: kinase inhibitors
Diluent: Withdraw and discard 120 mL
from 1000 mL bag of D5W. Withdraw Indications
40 mL from each vial and add to D5W In combination with letrozole in the treat-
bag. Do not use 0.9% NaCl; may cause ment of metastatic estrogen (ER)-positive
precipitation. Concentration: 1.2 human epidermal growth factor 2
mg/mL.Use within 6 hr at room temper- (HER2)-negative advanced breast cancer
ature or 12 hr if refrigerated, including in post-menopausal patients (part of ini-
3 hr infusion. Rate: Infuse over 3 hr. tial endocrine-based therapy).
Y-Site Incompatibility: Do not mix
Action
with other solutions or medications. Inhibits kinases (cyclin-dependent ki-
Flush line before and after infusion. nases 4 and 6) that are part of the signal-
Patient/Family Teaching ing pathway for cell proliferation. Thera-
Instruct patient to notify health care peutic Effects: Decreased spread of
professional if signs and symptoms of breast cancer.
pg 62 Plate
# 62 # 0-Composite
62 palbociclib
Pharmacokinetics 3 5 half-lives of offending drug have
Absorption: 46% absorbed following passed following discontinuation).
oral administration. Strong CYP3A inducers including car-
Distribution: Unknown. bamazepine, phenytoin, rifampin can
Metabolism and Excretion: Mostly plevels and effectiveness; concurrent use
metabolized (by CYP3A and sulfontrans- should be avoided. Moderate CYP induc-
ferase [SULT]); also acts as an inhibitor of ers including bosentan, efavirenz, etra-
CYP3A; 6.9% excreted unchanged in virine, modafinil and nafcillin may also
urine, 2.3% in feces. plevels and effectiveness; avoid concur-
Half-life: 29 hr. rent use.qlevels and effects/toxicity of al-
fentanil, cyclosporine, dihydroergo-
TIME/ACTION PROFILE (improvement tamine, ergotamine, everolimus,
in progression-free survival) fentanyl, midazolam, pimozide, quin-
ROUTE ONSET PEAK DURATION idine, sirolimus and tacrolimus; if
concurrent use is required dosepmay be
PO within 4 unknown maintained
mos through-
necessary.
out treat- Drug-Natural Products: St. Johns
ment wort mayplevels and effectiveness; avoid
concurrent use.
Contraindications/Precautions Drug-Food: Grapefruit/grapefruit
Contraindicated in: Stong/moderate juiceqlevels and the risk of toxicity, avoid
inhibitors of CYP3A (if necessarypdose ingestion.
of palbociclib); CYP3A inducers (mayp Route/Dosage
effectiveness); OB: Pregnancy (may cause PO (Adults): 125 mg daily for 21 days,
fetal harm); Lactation: Discontinue palbo- followed by 7 days off. Dose alteration may
ciclib or discontinue breast feeding. be required, depending on tolerance/tox-
Use Cautiously in: Concurrent use of icity. Letrozole 2.5 mg PO daily should be
sensitive CYP3A substrates (narrow thera- given concurrently.
peutic indices), dose of substrate may
need to bep; Severe renal impairment; Availability
OB: Patients with child-bearing potential; Capsules: 75 mg, 100 mg, 125 mg.
Pedi: Safe and effective use in children has NURSING IMPLICATIONS
not been established.
Adverse Reactions/Side Effects Assessment
Monitor for signs and symptoms of in-
CNS: weakness. CV: PULMONARY EMBO- fection (fever, chills, dizziness, short-
LISM. EENT: epistaxis. GI:pappetite, di-
ness of breath, weakness, increased
arrhea, nausea, stomatitis, vomiting. bleeding or bruising) during therapy.
Derm: alopecia. Hemat: NEUTROPENIA, Treat as medically appropriate. No dose
anemia, leukopenia, thrombocytopenia. adjustment is needed for Grade 1 or 2
Neuro: peripheral neuropathy. Misc: non-hematologic toxicities. For Grade
FEBRILE NEUTROPENIA.
3 (if persisting despite medical
Interactions treatment), withhold palbociclib until
Drug-Drug: Concurrent use with CYP3A symptoms resolve to: Grade 1; Grade
inhibitors including clarithromycin, 2 (if not considered a safety risk for
indinavir, itraconazole, ketocona- patient). Resume at next lower dose.
zole, lopinavir/ritonavir, nefazo- Monitor for signs and symptoms of pul-
done, nelfinavir, posaconazole, rito- monary embolism (shortness or breath,
navir, saquinavir, telaprevir, chest pain, tachypnea, tachycardia)
telithromycin, verapamil and vora- during therapy.
conazoleqlevels and the risk of toxicity; Lab Test Considerations: Monitor
avoid if possible but if unavoidablepdose CBC prior to and at beginning of each
of palbociclib (resume original dose after cycle, on Day 14 of first 2 cycles, and as
pg 63 Plate
# 63 # 0-Composite
peginterferon beta-1a 63
clinically indicated. May causepneu- and with each Rx refill in case of
trophil counts; median time to first epi- changes.
sode is 15 days (13 117 days) and Advise patient to avoid grapefruit or
median duration of Grade 3 neutro- grapefruit products during therapy; may
penia was 7 days. May cause febrile increase amount of palbociclib in
neutropenia. blood.
No dose reduction is needed for Grade Advise patient to notify health care pro-
1 or 2 hematologic toxicities. For Grade fessional if signs and symptoms of infec-
3, no dose adjustment required. Con- tion or pulmonary embolism occur.
sider repeating CBC monitoring in 1 wk. Instruct patient to notify health care
Withhold initiation of next cycle until professional of all Rx or OTC medica-
recovery to Grade 2. For Grade 3 ANC tions, vitamins, or herbal products be-
(1000 to 500/mm3) plus Fever ing taken and to consult with health
38.5C and/or infection, withhold care professional before taking other
palbociclib and initiation of next cycle medications.
until recovery to Grade 2 (1000/ Advise female patient to use effective
mm3. Resume at next lower dose. For contraception during and for at least 2
Grade 4, withhold palbociclib and initi- wks after last dose. Advise patient to no-
ation of next cycle until recovery to tify health care professional if preg-
Grade 2. Resume at lower dose. nancy is planned or suspected or if
May causepWBC, lymphocytes, hemo- breast feeding. Inform male patient that
globin, and platelets. palbociclib may compromise fertility.
Potential Nursing Diagnoses Evaluation/Desired Outcomes
Risk for infection (Adverse Reactions) Decrease in the spread of breast can-
cer.
Implementation
PO: Administer once daily at the same
time each day, for 21 consecutive days peginterferon beta-1a
followed by 7 days off treatment, with (peg-in-ter-feer-on bay-ta )
food in combination with letrozole once Plegridy
daily given throughout 28 day cycle.
Swallow capsules whole; do not open, Classification
crush, or chew; do not swallow cap- Thera: immune modifiers
sules that are broken, cracked, or not Pharm: interferons
intact.
If dose reduction needed for adverse Pregnancy Category C
reactions starting dose is 125 mg/day.
First dose reduction is to 100 mg/day, Indications
second dose reduction is to 75 mg/day; Treatment of relapsing forms of multiple
if further dose reduction needed, dis- sclerosis.
continue therapy.
Action
Patient/Family Teaching Antiviral and immunoregulatory proper-
Instruct patient to take palbociclib as ties produced by interacting with specific
directed. If a dose is vomited or missed, receptor sites on cell surfaces may explain
omit dose and take next dose at usual beneficial effects. Produced by recombi-
time; do not take an additional dose that nant DNA technology. Pegylation prolongs
day. Do not change dose or stop taking duration of action. Therapeutic Ef-
without consulting health care profes- fects: Reduced incidence of relapse
sional. Advise patient to read Patient (neurologic dysfunction) and slowed
Information before starting therapy physical disability.
pg 64 Plate
# 64 # 0-Composite
64 peginterferon beta-1a
Pharmacokinetics Availability
Absorption: Absorption follows subcu- Solution for subcutaneous injection
taneous administration. in prefilled pens and syringes: 63
Distribution: Unknown. mcg/0.5 mL, 94 mcg/0.5 ml, 125 mcg/0.5
Metabolism and Excretion: Under- mL.
goes catabolism; excretion is mainly renal.
Half-life: 78 hr. NURSING IMPLICATIONS
TIME/ACTION PROFILE (reduction in Assessment
relapse rate) Assess frequency of exacerbations of
symptoms of multiple sclerosis periodi-
ROUTE ONSET PEAK DURATION cally during therapy.
subcutane- within one 2436 wk unknown Monitor patient for signs of depression
ous mo during therapy. If depression occurs,
notify health care professional immedi-
Contraindications/Precautions ately.
Contraindicated in: Hypersensitivity to Monitor for injection site reactions (er-
natural or recombinant interferon beta or
ythema, pain, pruritus, edema, bruising,
peginterferon.
drainage, necrosis,) Avoid injecting
Use Cautiously in: History of depres- near area of reaction.
sion or suicidal ideation; History of sei-
Monitor patient with significant cardiac
zures; Renal impairment (risk of adverse
disease for worsening symptoms during
reactions may beq); Geri: Safe and effec-
initiation and periodically during ther-
tive use in geriatric patients has not been
established; OB: Use during pregnancy apy.
only if potential benefit justifies potential Lab Test Considerations: Monitor
fetal risk; Lactation: Use cautiously if serum AST, ALT and bilirubin periodi-
breast feeding; Pedi: Safe and effective use cally during therapy.
Monitor CBC with differential and plate-
in children has not been established.
let counts periodically during therapy.
Adverse Reactions/Side Effects May cause anemia,plymphocyte,p
CNS: SEIZURES, SUICIDAL IDEATION, head- neutrophil, andpplatelet counts.
ache, depression, weakness. CV: HF. GI:
HEPATOTOXICITY, nausea, vomiting. Derm: Potential Nursing Diagnoses
pruritus. Hemat:pperipheral blood Deficient knowledge, related to medica-
counts. Local: injection site pain/pruri- tion regimen (Patient/Family Teaching)
tus/reactions. MS: arthralgia, myalgia. Implementation
Misc: allergic reactions including ANA- Administer prophylactic analgesics and/
PHYLAXIS, AUTOIMMUNE DISORDERS, chills, or antipyretics to prevent or minimize
fever, flu-like symptoms. flu-like symptoms.
Interactions Subcut: Inject subcut in abdomen,
Drug-Drug:qmyelosuppression may back of upper arm, and thigh every 14
occur with other myelosuppressives in- days; rotate sites. Prefilled pens are for
cluding antineoplastics. Concurrent use single dose; discard after use.
of hepatotoxic agents mayqthe risk of Patient/Family Teaching
hepatotoxicity (qliver enzymes). Instruct patient in correct technique for
Drug-Natural Products: Avoid con- injection and care and disposal of
commitant use with immunomodulating equipment. Avoid injecting into areas of
natural products such as astragalus, skin irritation, redness, bruising, infec-
echinacea, and melatonin. tion, or scarring. Check injection site 2
Route/Dosage hr after injection for redness, swelling,
Subcut (Adults): 63 mcg initially, fol- and tenderness. Notify health care pro-
lowed by 94 mcg on day 15, then 125 mcg fessional if skin reaction does not clear
every 14 days. in a few days. Caution patient not to re-
pg 65 Plate
# 65 # 0-Composite
pembrolizumab 65
use needles or syringes and provide pa-
tient with a puncture-resistant container pembrolizumab
for disposal. (pem-broe-li-zoo-mab)
Instruct patient to take medication as Keytruda
directed; do not change dose or sched-
ule without consulting health care pro- Classification
fessional. Advise patient to read Medi- Thera: antineoplastics
cation Guide prior to starting therapy Pharm: monoclonal anti-
and with each Rx refill in case of
changes.
bodies
Inform patient that flu-like symptoms Pregnancy Category D
(headache, fever, chills, myalgia, sweat-
ing, malaise, tiredness) may occur dur- Indications
ing therapy. Acetaminophen may be Treatment of unresectable or metastatic
used for relief of fever and myalgias. melanoma with disease progression de-
Flu-like symptoms are not contagious. spite ipilimumab and a BRAF inhibitor (if
Advise patient to notify health care pro- positive for the BRAF V600 mutation).
fessional immediately if signs and symp-
toms of liver disease (yellowing of skin Action
or whites of eyes, nausea, loss of appe- Programmed death (PD) receptor-1
tite, tiredness, bleeding easily, confu- blocking antibody (an IgG4 kappa im-
sion, sleepiness, dark colored urine, munglobulin) that blocks the interaction
pale stools), depression, suicidal between PD-1 and its ligands PD-L1 and
thoughts, seizures, allergic reactions PD-L2 resuling in inhibition of T-cell pro-
(itching; swelling of face, eyes, lips, liferation and decreased cytokine produc-
tongue, throat; trouble breathing; feel- tion. Therapeutic Effects: Decreased
ing faint; anxiousness; rash; hives) or spread of melanoma.
autoimmune diseases (easy bleeding or Pharmacokinetics
bruising, thyroid gland problems, auto- Absorption: IV administration results in
immune hepatitis) occur. complete bioavailability.
Instruct patient to notify health care Distribution: Unknown.
professional of all Rx or OTC medica- Metabolism and Excretion: Un-
tions, vitamins, or herbal products be- known.
ing taken and to consult with health Half-life: 26 days.
care professional before taking other TIME/ACTION PROFILE (response)
medications.
Advise patient to notify health care pro- ROUTE ONSET PEAK DURATION
fessional if pregnancy is planned or sus- IV within 3 mo unk may persist
pected or if breast feeding. for 8.8
mos
Decrease in the frequency of relapse Contraindications/Precautions
(neurologic dysfunction) in patients Contraindicated in: OB: Pregnancy
with relapsing-remitting multiple scle- (may cause fetal harm); Lactation: Dis-
rosis. continue pembrolizumab or discontinue
breast feeding.
Use Cautiously in: OB: Females with
reproductive potential; Moderate to severe
hepatic impairment; Pedi: Safe and effec-
tive use in children has not been estab-
lished.
pg 66 Plate
# 66 # 0-Composite
66 pembrolizumab
Adverse Reactions/Side Effects ing of urine, unusual tiredness, pain in
CNS: dizziness, fatigue, headache, insom- right upper stomach) before each dose.
nia. Resp: IMMUNE-MEDIATED PNEUMONI- Treat with corticosteroids for Grade
TIS. GI: IMMUNE-MEDIATED COLITIS, IM- 2. Withhold or discontinue pembroli-
MUNE-MEDIATED HEPATITIS,pappetite, zumab depending on severity of liver
constipation, diarrhea, nausea. GU: IM- enzyme elevations. Resume therapy
MUNE-MEDIATED NEPHRITIS. Derm: pruri- when recovery to Grade 0 to 1.
tus, rash, vitiligo. Endo: IMMUNE-MEDI- Monitor for clinical signs and symptoms
ATED HYPOPHYSITIS, immune-mediated of hypophysitis (persistent or unusual
hyperthyroidism, immune-mediated hypo- headache, extreme weakness, dizziness
thyroidism. MS: arthralgia, back pain, ex- or fainting, vision changes) during ther-
tremity pain, mylagia. Hemat: anemia. apy. Treat with corticosteroids for
Misc: SEPSIS, other immune mediated ad- Grade 2 hypophysitis. Withhold pem-
verse reactions. brolizumab and monitor symptoms for
moderate (Grade 2) hypophysitis; with-
Interactions hold or discontinue for severe (Grade
Drug-Drug: None noted. 3), and resume therapy when recovery
Route/Dosage to Grade 0 to 1. Permanently discon-
IV (Adults): 2 mg/kg every 3 wk. tinue for life-threatening (Grade 4) hy-
pophysitis.
Availability Lab Test Considerations: Monitor
Lyophilized powder for injection (re- for changes in renal function. Treat with
quires reconstitution): 50 mg/single corticosteroids for Grade 2 nephritis.
use vial. Withhold pembrolizumab and monitor
symptoms for moderate (Grade 2) ne-
NURSING IMPLICATIONS phritis; resume therapy when recovery
Assessment to Grade 0 to 1. Permanently discon-
Monitor for signs and symptoms of im- tinue for severe (Grade 3) or life-
mune-mediated pneumonitis (short- threatening (Grade 4) nephritis.
ness of breath, chest pain, new or Monitor for changes in thyroid function
worse cough) periodically during ther- at start of and periodically during ther-
apy. Evaluate with x-ray. Treat with cor- apy, and as indicated based on clinical
ticosteroids for Grade 2 pneumonitis. evaluation. Administer corticosteroids
Withhold pembrolizumab and monitor for Grade 3 hyperthyroidism, with-
symptoms for moderate (Grade 2) hold pembrolizumab for severe (Grade
pneumonitis; resume therapy when re- 3) hyperthyroidism and resume therapy
covery to Grade 0 to 1. Permanently dis- when recovery to Grade 0 to 1. Perma-
continue for severe (Grade 3) or life- nently discontinue for life-threatening
threatening (Grade 4) pneumonitis. (Grade 4) hyperthyroidism. Manage hy-
Monitor for signs and symptoms of coli- pothyroidism with thyroid replacement
tis (diarrhea, abdominal pain, mucus without interruption of therapy or corti-
or blood in stool, with or without fe- costeroids.
ver). Treat with corticosteroids for Potential Nursing Diagnoses
Grade 2 colitis. Withhold pembroli- Diarrhea (Adverse Reactions)
zumab and monitor symptoms for mod- Deficient knowledge, related to medica-
erate (Grade 2) or severe (Grade 3) tion regimen (Patient/Family Teaching)
colitis; resume therapy when recovery Implementation
to Grade 0 to 1. Permanently discon-
tinue for life-threatening (Grade 4) co- IV Administration
litis. Intermittent Infusion: Reconstitute
Assess for signs and symptoms of im- by injecting 2.3 mL of Sterile Water for
mune-mediated hepatitis (yellowing of Injection along vial walls; swirl slowly,
skin or whites of eyes, unusual darken- do not shake. Allow up to 5 min for
pg 67 Plate
# 1 # 0-Composite
peramivir 67
bubbles to clear. Solution is clear to
slightly opalescent, colorless to slightly peramivir
yellow; do not administer solution if (per-am-a-veer)
discolored or contains particulate mat- Rapivab
ter other than translucent to white pro-
teinaceous particles. Solution is stable Classification
at room temperature for up to 4 hr and Thera: antivirals
24 hr if refrigerated. Diluent: 0.9% Pharm: neuraminidase in-
NaCl. Mix using gently inversion. Con-
centration: 1 mg/mL to 10 mg/mL.
hibitors
Rate: Infuse through a sterile, non-py- Pregnancy Category C
rogenic, low-protein binding 0.2 mi-
cron to 0.5 micron in-line or add-on fil- Indications
ter over 30 min. Treatment of acute uncomplicated influ-
Y-Site Incompatibility: Do not ad- enza in patients 18 yr who have had
minister other drugs through same infu- symptoms for two days or less.
sion line.
Action
Patient/Family Teaching Inhibits the enzyme neuraminidase, which
Explain purpose of pembrolizumab to may alter virus particle aggregation and
patient. release. Therapeutic Effects: Reduced
Advise patient to notify health care pro- duration or prevention of flu-related
fessional immediately if signs and symp- symptoms.
toms of pneumonitis, colitis, hepatitis,
kidney problems (change in amount or Pharmacokinetics
color of urine), hormone gland prob- Absorption: IV administration results in
lems (rapid heart beat, weight loss, in- complete bioavailaility.
creased sweating, weight gain, hair loss, Distribution: Unknown.
feeling cold, constipation, deepening of Metabolism and Excretion: Mostly
voice, muscle aches, dizziness or faint- eliminated unchanged by kidneys
ing, persistent or unusual headache) ( 90%).
occur. Half-life: 20.8 hr.
professional of all Rx or OTC medica- TIME/ACTION PROFILE (blood
tions, vitamins, or herbal products be- levels)
ing taken and to consult with health ROUTE ONSET PEAK DURATION
care professional before taking other IV rapid end of in- unknown
medications. fusion
Advise female patient of reproductive
potential to use highly effective contra- Contraindications/Precautions
ception during and for 4 mo after last Contraindicated in: None noted.
dose; may cause fetal harm. Avoid Use Cautiously in: Renal impairment
breast feeding during therapy. (dose reduction required for CCr 50
Emphasize importance of keeping mL/min); Geri: Consider age-related de-
scheduled appointments for blood crease in hepatic, renal, cardiac function,
work or other laboratory tests. concurrent diseases and drug therapy;
Evaluation/Desired Outcomes OB: Use only if clearly needed; Lactation:
pspread of melanoma. Consider benefits of breast feeding, need
for peramivir and potential for adverse ef-
fects; Pedi: Safety and effectiveness in chil-
dren 18 yr has not been established.
pg 68 Plate
# 68 # 0-Composite
68 pirfenidone
Adverse Reactions/Side Effects reach room temperature prior to ad-
CNS: insomnia, neuropsychiatric events. ministration. Discard unused portion of
CV: hypertension. GI: constipation. single use vial. Rate: Infuse over 15 to
Derm: skin reactions including STEVENS- 30 min.
JOHNSON SYNDROME. Y-Site Incompatibility: Do not ad-
minister simultaneously with any other
Interactions medication.
Drug-Drug: Avoid use of live attenu-
ated influenza vaccine within 2 wk Patient/Family Teaching
prior and 48 hr after peramivir; interfer- Explain purpose of peramivir to patient.
ence may occur. Advise patient to notify health care pro-
fessional if signs and symptoms of ana-
Route/Dosage phylaxis or rash, or neuropsychiatric
IV (Adults and Children 18 yr (CCr symptoms occur.
50 mL/min): 600 mg .
Renal Impairment care professional if pregnancy is
IV (Adults and Children 18 yr): CCr planned or suspected or if breast feed-
30 49 mL/min 200 mg, CCr 10 29 ing.
mL/min 100 mg. Evaluation/Desired Outcomes
Availability Resolution of sign and symptoms of in-
Solution for IV use: 200 mg/ 20 mL vial. fluenza.
pirfenidone
Assessment (peer-feh-nih-done)
Assess for signs and symptoms of influ-
enza (fever, dyspnea, tachypnea, tachy-
Esbriet
cardia, hypotension) prior to and at Classification
least daily during therapy. Patient must Thera: agents for pulmo-
be symptomatic for no more than 2
days to receive peramivir. nary fibrosis
Monitor for signs of neuropsychiatric Pharm: pyridones
symptoms (hallucinations, delirium, Pregnancy Category C
abnormal behavior) during therapy.
Assess patient for skin rash during ther-
apy. Monitor closely and treat sympto-
Indications
Treatment of idiopathic pulmonary fibro-
matically.
sis (IPF).
Lab Test Considerations: May
causeqserum ALT, AST, glucose, crea- Action
tine phosphokinase, andpneutrophils. Has antithrombotic and anti-inflammatory
Potential Nursing Diagnoses properties. Therapeutic Effects:
Risk for infection (Indications) Slowed progression of IPF.
Implementation Pharmacokinetics
Absorption: Absorption follows oral ad-
IV Administration ministration. Foodprate and extent of ab-
Intermittent Infusion: Diluent: sorption.
0.9% NaCl or 0.45% NaCl, D5, or LR to Distribution: Unknown.
a maximum volume of 100 mL.Solution Metabolism and Excretion: Mostly
is clear and colorless; do not adminis- metabolized by the CYP1A2 enzyme sys-
ter solution that is discolored or con- tem, some metabolism by other CYP en-
tains a precipitate. Upon dilution, ad- zymes. 80% excreted in urine as inactive
minister immediately or refrigerate up metabolite.
to 24 hrs; discard after 24 hrs. Allow to Half-life: 3 hr.
pg 69 Plate
# 69 # 0-Composite
pirfenidone 69
TIME/ACTION PROFILE (effects on blood levels and risk of toxicity (discon-
pulmonary function) tinue prior to treatment). Concurrent use
of strong inducers of CYP1A2 mayp
ROUTE ONSET PEAK DURATION blood levels and effectiveness (discon-
PO within 3 67 mos unknown tinue prior to treatment).
mos
Route/Dosage
Contraindications/Precautions PO (Adults): Days 1 7 267 mg (one
Contraindicated in: End-stage renal capsule) three times daily, days 8 14
disease on dialysis; Concurrent use of 534 mg (two capsules) three times daily,
strong inducers of CYP1A2; Severe hepatic day 15 and onward 801 mg (three
impairment; Lactation: Discontinue pir- capsules) three times daily. If treatment is
fenidone or discontinue breast feeding. interrupted for 14 days or more, two wk
Use Cautiously in: Concurrent use of upward titration is recommended. Con-
strong inhibitors of CYP1A2 (concurrent current use of strong inhibitors of
use not recommended but if unavoidable CYP1A2 (including fluvoxamine and
pdose); Mild to moderate hepatic im- enoxacin) 267 mg (one capsule)
pairment (close monitoring recom- three times daily. Concurrent use of
mended, permanent discontinuation may moderate inhibitors of CYP1A2 includ-
be necessary); Renal impariment (CCr ing ciprofloxacin 750 mg twice daily
80 ml/min), monitor carefully/consider
534 mg (two capsules) three times daily
dose reduction; Exposure to sunlight; Cig- (if lower dose of ciprofloxacin is used,
arette smokers (may havepblood levels close monitoring with no dose alteration is
and effectiveness, encourage cessation recommended).
prior to treatment); OB: Use during preg- Availability
nancy only if benefit out weighs risk to pa- Capsules: 267 mg.
tient; Pedi: Safe and effective use in chil-
dren has not been established. NURSING IMPLICATIONS
Adverse Reactions/Side Effects Assessment
CNS: dizziness, fatigue, headache, insom- Monitor for signs and symptoms of pul-
nia, weakness. GI: abdominal pain, ano- monary fibrosis (dyspnea, decreased
rexia, gastrointestinal reflux disease, nau-forced vital capacity (FVC), diffuse pul-
sea, diarrhea, dyspepsia, vomiting, weight monary infiltrates on chest x-ray) dur-
loss, dysgeusia,qliver enzymes. Derm: ing therapy.
rash, photosensitivity, pruritus. MS: ar- Assess for signs and symptoms of GI
thralgia. disorders (nausea, diarrhea, dyspepsia,
vomiting, gastro-esophageal reflux dis-
Interactions ease, abdominal pain) during therapy;
Drug-Drug: Concurrent use of strong occurs most often during first 3 mo of
inhibitors of CYP1A2 including fluvox- therapy, then decreases. May require
amine and enoxacinqblood levels and dose reductions.
risk of toxicity (concurrent use not rec- Lab Test Considerations: Monitor
ommended, if unavoidablepdose of pir- liver function before starting, moly for
fenidone). Concurrent use of moderate first 6 mo, then every 3 mo thereafter
inhibitors of CYP1A2 including cipro- during therapy. If AST and/or ALT 3
floxacinqblood levels and risk of toxic- times but 5 time upper limit of nor-
ity (dosage reductions are recommended mal without symptoms or hyperbili-
for higher dose of ciprofloxacin, close rubinemia after starting pifenidone,
monitoring for lower dose). Concurrent discontinue confounding medications,
use of other inhibitors of CYP enzymes exlcude other causes, and monitor pa-
including 2C9, 2C19, 2D6, and 2E1q tient closely. Repeat liver tests as
pg 70 Plate
# 70 # 0-Composite
70 ramucirumab
needed. Full daily dose may be main- planned or expected or if breast feed-
tained or reduced or interrupted until ing.
liver tests within normal limits with sub- Emphasize the importance of follow up
sequent re-titration to full dose as toler- blood tests to determine liver function.
ated. If AST and/or ALT 3 times but
5 times upper limits of normal ac-
companied by symptoms or hyperbili- Decrease in rate of decline in forced vi-
rubinemia, permanently discontinue tal capacity (FVC) and extension in time
pifenidone; do not rechallenge patient to first exacerbation of pulmonary fi-
with pifenidone. If AST and/or ALT 5 brosis.
times upper limit of normal, perma-
nently discontinue pifenidone; do not
rechallenge patient with pifenidone.
ramucirumab
(ra-mue-sir-ue-mab)
Potential Nursing Diagnoses Cyramza
Ineffective breathing pattern (Indications)
Implementation Classification
PO: Administer capsules with food to Thera: antineoplastics
minimize nausea and dizziness, at same Pharm: vascular endothe-
time each day following titration sched- lial growth-factor antago-
ule above. nists
Instruct patient to take pirfenidone as
directed. Take missed dose as soon as
remembered; do not double doses or Indications
take more than 3 doses/day. Advise pa- Treatment of advanced gastric cancer or
tient to read Patient Information prior gastro-esophageal junction adenocarci-
to starting therapy and with each Rx re- noma following unsuccessful combination
fill in case of changes. treatment that included a fluoropyrimidine
Advise patient to notify health care pro- or platinum compound.
fessional if signs and symptoms of liver Action
dysfunction (skin or whites of eyes turn A monoclonal antibody that binds to vas-
yellow, dark brown or tea colored cular endothelial growth factor receptor 2
urine, pain on right side of stomach, (VEGFR 2), antagonizing its effects, result-
bleeding or bruising, lethargy) or GI ing in decreased angiogenesis. Thera-
dysfunction occur. peutic Effects: Decreased growth and
Advise smokers to stop smoking prior spread of gastric cancer or gastro-esopha-
to and avoid smoking during therapy. geal junction adenocarcinoma.
Caution patient to use sunscreen (SPF
50 of higher) and protective clothing to Pharmacokinetics
prevent photosensitivity reactions and to Absorption: IV administration results in
avoid concurrent medications that complete bioavailability.
cause photosensivity. May require dose Distribution: Unknown.
reduction or discontinuation. Metabolism and Excretion: Un-
Advise patient to notify health care pro- known.
fessional of all Rx or OTC medications, Half-life: Unknown.
vitamins, or herbal products being
taken and to consult with health care TIME/ACTION PROFILE (improved
professional before taking other medi- survival)
cations. ROUTE ONSET PEAK DURATION
IV within 1 mo 78 mos 24 mos
care professional if pregnancy is
pg 71 Plate
# 71 # 0-Composite
ramucirumab 71
Contraindications/Precautions and permanently discontinue ramuciru-
Contraindicated in: OB: May cause fe- mab if Grade 3 or 4 reactions occur.
tal harm; Lactation: Discontinue ramuci- Monitor blood pressure prior to and at
rumab or discontinue breast feeding. least every 2 wks during therapy. Inter-
Use Cautiously in: Child-Pugh Class B rupt therapy for severe hypertension
or C cirrhosis (use only if benefits out- until blood pressure is under control.
weigh risk of further deterioration); Sur- Permanently discontinue if unable to
gery (discontinue prior to surgery, rein- control hypertension.
state when healing is complete); Avoid administration prior to surgery or
Hypertension (must be controlled prior to until wound is healed.
treatment); Pedi: Safe and effective use in If arterial thromboembolic events
children has not been established. (myocardial infarction, cardiac arrest,
Adverse Reactions/Side Effects cerebrovascular accident, cerebral is-
CNS: Reversible Posterior Leukoencepha- chemia), GI perforation, or Grade 3 or
lopathy Syndrome, headache. CV: ARTE- 4 bleeding occur, permanently discon-
RIAL THROMBOTIC EVENTS, hypertension.
tinue.
GI: GASTROINTESTINAL OBSTRUCTION/PERFO- Lab Test Considerations: Monitor
RATION, diarrhea, worsened cirrhosis/hep-
urinary protein periodically during
atorenal syndrome, diarrhea. GU: im- therapy. Interrupt ramucirumab for
paired female fertility, proteinuria. F and urine protein 2 g/24 hrs. Reinitiate
E: hyponatremia. Hemat: BLEEDING, neu- therapy at reduced dose of 6 mg/kg
tropenia. Misc: infusion-related reac- every 2 wks once urinary protein levels
2 g/24 hrs. If protein level returns to
tions, impaired wound healing.
2 g/24 hrs interrupt therapy and re-
Interactions duce dose to 5 mg/kg every 2 wks once
Drug-Drug: Increased risk of bleeding urinary protein levels return to 2 g/24
with anticoagulants, antiplatelet hrs. Discontinue therapy permanently if
agents and NSAIDs. urine protein level 3 g/24 hrs or if ne-
Route/Dosage phrotic syndrome occurs.
IV (Adults): 8 mg/kg every 2 wk, pre- Potential Nursing Diagnoses
medication with histamine H1 antagonist Deficient knowledge, related to medica-
(antihistamine) is required. Dose adjus- tion regimen (Patient/Family Teaching)
ment/interruption/discontinuation re-
quired for drug-related toxicities. Implementation
Prior to each dose, premedicate all pa-
Availability tients with IV histamine H1 antagonist
Solution for intravenous infusion (diphenhydramine). Premedicate pa-
(requires further dilution): 100 mg/ tients who have experienced a Grade 1
10 mL vial (10 mg/mL), 500 mg/50 mL or 2 infusion reaction with dexametha-
vial (10 mg/mL). sone and acetaminophen prior to each
NURSING IMPLICATIONS infusion.
Assessment IV Administration
Monitor for infusion-related reactions Intermittent Infusion: Withdraw re-
(rigors/tremors, back pain/spasms, quired volume from vial. Diluent: Di-
chest pain and/or tightness, chills, flush- lute with 0.9% NaCl for a final volume of
ing, dyspnea, wheezing, hypoxia, pares- 250 mL. Do not use dextrose-containing
thesia, bronchospasm, supraventricular solutions. Gently invert to ensure ade-
tachycardia, hypotension) during infu- quate mixing. Solution is clear to
sion. Reduce infusion rate by 50% for slightly opalescent and colorless to
Grade 1 or 2 reactions, and immediately slightly yellow; do not administer solu-
pg 72 Plate
# 1 # 0-Composite
72 secukinumab
tions that are discolored or contain par- Indications
ticulate material. Solution is stable for Treatment of moderate to severe plaque
24 hr if refrigerated or 4 hrs at room psoriasis.
temperature. Discard unused solution. Action
Rate: Infuse over 60 min via infusion A monoclonal antibody that acts as an an-
pump through a separate infusion line tagonist of interleukin (IL) 17A by selec-
using a 0.22 micron filter; do not ad- tively binding to it and preventing its
minister as IV push or bolus. Flush line interaction with the IL 17 receptor. An-
with 0.9% NaCl at end of infusion. tagonism prevents the production of in-
Y-Site Incompatibility: Do not dilute
flammatory cytokines and chemokines.
with other solutions or infuse with other
electrolyte solutions or medications.
Therapeutic Effects: Decreased plaque
formation and spread.
Patient/Family Teaching Pharmacokinetics
Explain purpose of ramucirumab to pa-
Absorption: Well absorbed following
tient. subcutaneous administration.
Distribution: Levels in interstitial fluid
fessional if bleeding or lightheadedness of skin (lesional and non-lesional) are
occur. 27 40% those of serum.
Instruct patient in self blood pressure
monitoring and advise patient to notify
Metabolism and Excretion: Catabo-
lized into small peptides and amino acids.
health care professional if signs and
symptoms of hypertension (elevated Half-life: 22 31 days.
blood pressure, severe headache, light- TIME/ACTION PROFILE (blood level)
headedness, neurologic symptoms) or
if severe diarrhea, vomiting, or severe
abdominal pain occur. subcut unknown 6 hr unknown
Advise to notify health care professional
of medication regimen prior to surgery;
may impair wound healing. Contraindicated in: Hypersensitivity.
Advise female patient that ramucirumab
Use Cautiously in: Chronic infection/
history recurrent infection (incuding tu-
may impair fertility and to use effective
contraception during and for at least 3berculosis); History of Crohns Disease
mo after last dose. Notify health care (exacerbation may occur); OB: Use dur-
professional if pregnancy is suspected ing pregnancy only if potential benefit jus-
tifies potential risk to fetus;Lactation: Use
and avoid breast feeding during therapy.
cautiously if breast feeding; Pedi: Safe and
Evaluation/Desired Outcomes effective use in children has not been es-
Decreased growth and spread of gastric tablished.
cancer or gastroesophageal junction Adverse Reactions/Side Effects
adenocarcinoma. GI: diarrhea. Misc: hypersensitivity reac-
tions including ANAPHYLAXIS, INFECTIONS.
secukinumab Interactions
(sek-ue-kin-ue-mab) Drug-Drug:qrisk of adverse reactions
Cosentyx with live vaccines; do not administer
concurrently. Administration of non-live
Classification vaccines may not elicit antibody response
Thera: antipsoriatics sufficient to produce protection. May af-
Pharm: interleukin antago- fect activity of CYP450 enzymes and may
alter the effectiveness/toxicity of drugs
nists that are substrates of
Pregnancy Category B CYP450(including warfarin and cyclo-
sporine; close monitoring is recom-
pg 73 Plate
# 73 # 0-Composite
secukinumab 73
mended and necessary dose modifications berculosis should be started before
undertaken. therapy with secukinumab.
Monitor patients with Crohns disease
Route/Dosage closely; may cause exacerbations.
Subcut (Adults): 300 mg once weekly
for 5 wk, then every 4 wk; for selected pa- Potential Nursing Diagnoses
tients a dose of 150 mg may be sufficient. Risk for infection (Side Effects)
Availability Implementation
Solution for subcutaneous injection Administer a tuberculin skin test prior
(caps contain latex): 150 mg/1 mL in to administration of secukinumab. Pa-
Sensoready pen, 150 mg/1 mL in prefilled tients with active latent TB should be
syringe. Lyophilized powder for sub- treated for TB prior to therapy.
cutaneous injection (requires recon- Immunizations should be current prior
stitution): 150 mg single-use vial. to initiating therapy. Patients on secu-
kinumab may receive concurrent vacci-
NURSING IMPLICATIONS nations, except for live vaccines.
Administer initial injection under super-
Assessment vision of a health care professional.
Assess skin lesions periodically during Vial is for institutional use only. With
therapy. training, patient may use pen and pre-
Assess for signs of infection (fever; filled syringes at home.
dyspnea; sweats; chills; muscle aches; Solution is slightly opalescent and col-
cough; blood in phlegm; weight loss; orless to slightly yellow. Do not admin-
frequent or painful urination; warm ister solutions that are discolored or
red, or painful skin or sores; diarrhea; contain particulate matter. Discard un-
stomach pain), including tuberculosis, used solution.
prior to and periodically during ther- Remove vial from refrigerator and allow
apy. Secukinumab is contraindicated in to stand for 15 to 30 min to reach room
patients with active infection. New infec- temperature. Reconstitute by slowly in-
tions should be monitored closely; most jecting 1 mL of Sterile Water for Injec-
common are upper respiratory tract in- tion into vial directing stream onto pow-
fections, bronchitis, and urinary tract der. Tip vial 45 and gently rotate
infections. Infections may be fatal, espe- between fingertips for 1 min; do not
cially in patients taking immunosup- shake or invert vial. Allow to stand at
pressive therapy. room temperature for 5 min. Reconsti-
Assess patient for latex allergy. Needle tuted solutions contains 150 mg secu-
cover of syringe contains latex and kinumab/mL. Use solution immediately
should not be handled by persons sen- or refrigerate for up to 24 hr; do not
sitive to latex. freeze. Administer within 1 hr of re-
Monitor patient for signs of anaphylaxis moval from refrigerator.
(urticaria, dyspnea, facial edema) fol- Subcut: Administer at a 45 angle in
lowing injection. Medications (antihis- upper thighs or abdomen, avoiding the
tamines, corticosteroids, epinephrine) 2 inches around navel. Put pressure on
and equipment should be readily avail- injection site for 10 sec, do not rub. Ro-
able in the event of a severe reaction. tate injection sites; avoid areas that are
Discontinue secukinumab immediately tender, bruised, hard, or red. Refriger-
if anaphylaxis or other severe allergic ate prefilled syringes and pens.
reaction occurs. Patient/Family Teaching
Assess patient for latent tuberculosis Instruct patient on the correct tech-
with a tuberculin skin test prior to initi- nique for administering secukinumab.
ation of therapy. Treatment of latent tu- Review Medication Guide, preparation
pg 74 Plate
# 1 # 0-Composite
74 short ragweed pollen allegen extract

of dose, administration sites and tech- Classification
nique, and disposal of equipment into a Thera: immmunotherapyal-
puncture-resistant container.
Caution patient to notify health care lergy, cold, and cough
professional immediately if signs of in- remedies
fection, severe rash, swollen face, or Pharm: antigens
difficulty breathing occur while taking
secukinumab. Pregnancy Category C
fessional of all Rx or OTC medications, Indications
vitamins, or herbal products being Treatment of ragweed-induced allergic
taken and to consult with health care rhinitis with/without conjunctivitis, con-
professional before taking other medi- firmed by testing to be associated with the
cations. presence of pollen-specific IgE antibodies.
Instruct patient to notify health care Action
professional of medication regimen Small doses of antigen produce T-cell acti-
prior to treatment or surgery. vation and downregulation of mucosal
Advise female patients to notify health mast cells; additional effects includepIgE
care professional if pregnancy is production,qspecific immunoglobulin
planned or suspected or if breast feed- G4 (IgG4) production and changes in in-
ing. terleukin and eosinophil activity. Thera-
Pen: Clean area for injection with al- peutic Effects: Decreased symptoms
cohol swab. Hold pen with cap point- (rhinitis/conjunctivitis) and need for daily
ing up. Check solution through win- medication to control symptoms.
dow; if discolored, cloudy, or contains Pharmacokinetics
flakes, discard solution. Remove cap. Absorption: Unknown.
Place pen, with window visible, against Distribution: Unknown.
skin at a 90 angle and press button Metabolism and Excretion: Un-
until 2 clicks are heard. First click in- known.
dicates injection started; 2nd click in- Half-life: Unknown.
dicates injection is almost complete.
Hold pen in place until all solution is TIME/ACTION PROFILE (decrease in
injected (10 seconds) and green symptoms/need for medications)
marker is visible in window and has ROUTE ONSET PEAK DURATION
filled window. Remove needle and
SL 12 wk unknown maintained
press with a gauze pad or cotton ball through-
for 10 seconds. Do not rub injection out pol-
site. Dispose of pen into a puncture- len sea-
resistant container. son

Reduced severity of plaques in patients Contraindicated in: Severe/unstable/
with severe chronic plaque psoriasis. uncontrolled asthma; History of severe al-
munotherapy; History of hypersensitivity to
inactive ingredients.
Use Cautiously in: Oral inflammation/
short ragweed pollen wounds including oral surgery/dental ex-
traction, oral lichan planus, mouth ulcers
allegen extract or thrush (discontinue temporarily); Geri:
(short rag-week po-len a- Safe and effective use in elderly patients
ler-jenex-tract) has not been established, not approved for
Ragwitek this age group; OB: Use during pregnancy
pg 75 Plate
# 75 # 0-Composite
short ragweed pollen allegen extract 75

only if clearly needed; Lactation: Use cau- throat tightness or swelling, trouble
tiously if breast feeding; Pedi: Safe and ef- swallowing or speaking, dizziness or
fective use in children has not been estab- fainting, rapid or weak heartbeat, se-
lished. vere stomach cramps or pain, vomiting,
Adverse Reactions/Side Effects diarrhea, severe flushing or itching) for
GI: oral paresthesia, oral prutitus, tongue at least 30 min after initial dose. Keep
pruritus, eosinophilic esophagitis, mouth epinephrine, an antihistamine, and re-
edema. EENT: throat irritation, ear pruri- suscitation equipment close by in the
event of an anaphylactic reaction. Dis-
tus. Resp: LARYGOPHARYNGEAL SWELLING,
continue therapy of severe allergic re-
oropharyngeal pain. Misc: allergic reac-
action occurs. If persistent or escalating
tions including ANAPHYLAXIS.
reactions occur, re-evaluate therapy
Interactions and consider discontinuation.
Drug-Drug: Concurrent allergen im- Monitor for signs and symptoms of eo-
munotherapy mayqrisk of adverse re- sinophilic esophagitis (severe or per-
actions. Concurrent beta blockers may sistent gastro-esophageal symptoms,
presponse to bronchodilators or paren- dysphagia, chest pain). Discontinue
teral epinephrine if required for severe al- therapy and consider diagnosis if symp-
lergic reactions to pollen extract. Alpha toms occur.
blockers and beta blockers blunt the Monitor for signs and symptoms of
beneficial effects of epinephrine which asthma attack (wheezing, coughing,
may be required to treat anaphylaxis (q dyspnea) before administering. With-
dose of epinephrine may be required). hold if patient experiencing acute
Ergot alkaloids may reverse the pressor asthma exacerbation. If recurrent
effects of epinephrine. Effects of epineph- asthma exacerbations occur, consider
rine may beqby tricyclic antidepres- discontinuation of therapy.
sants, levothyroxine, MAO inhibitors Assess for oral inflammation (oral li-
and some antihistamines including chen planus, mouth ulcers, thrush)
chlorpheniramine and diphenhyra- prior to administration. Allow healing
mine. Cardiac glycosides mayqrisk of before administration.
adverse cardiovascular events with epine- Potential Nursing Diagnoses
prine. Ineffective breathing pattern (Indications)
Route/Dosage Implementation
SL (Adults 18 65 yr): One tablet daily, Therapy should be started at least 12
started at least 12 wk prior to onset of rag- wks prior to onset and throughout rag-
weed pollen season, continued throughout weed pollen season. Administer first
season. dose in health care setting and monitor
Availability patient for allergic reactions for at least
Sublingual tablet (contains gelatin, 30 min. If no reactions occur, patient
mannitol and sodium hydroxide): 12 may administer subsequent doses at
Amb a 1 Unit (Amb a 1 U). home.
SL: Remove tablet from blister just
NURSING IMPLICATIONS prior to dosing. Immediately place tab-
Assessment let under tongue until complete dissolu-
Assess for signs and symptoms of al- tion for at least 1 min before swallow-
lergy (sneezing; runny or itchy nose; ing. Wash hands after handling tablet.
nasal congestion; itchy, watery eyes) be- Patient/Family Teaching
fore and periodically during therapy. Instruct patient in correct method of
Monitor for signs and symptoms of al- taking Ragwitek; avoid swallowing tab-
lergic reactions (trouble breathing, let until dissolved. Avoid food or bever-
pg 76 Plate
# 76 # 0-Composite
76 suvorexant
age for 5 min after dissolution of tablet. promote wakefulness, by binding to their
If dose is missed, omit and take next receptors. Therapeutic Effects: Im-
scheduled dose next day; do not double proved sleep.
doses. If more than 1 dose is missed, Pharmacokinetics
notify health care professional before
Absorption: 82% absorbed following
restarting. Explain to patient that ther-
oral administration; a high fat meal will
apy does not give immediate relief of al-
delay absorption and sleep onset.qab-
lergy symptoms. Instruct patient to read
sorption in obese females.
Medication Guide before starting ther-
apy and with each Rx refill in case of Distribution: Does not distribute into
changes. RBCs.
Instruct patient in how and when to use Protein Binding: 99%.
autoinjectable epinephrine and to seek Metabolism and Excretion: Exten-
immediate medical care if used. sively metabolized by CYP3A (minor me-
Advise patient to stop therapy notify tabolism by CYP2C19; metabolites are not
health care professional if signs and active). 66% excreted in feces, 23% in
symptoms of allergic reactions, asthma urine, mostly as metabolites.
attack, oral inflammation, or eosino- Half-life: 12 hr (qin hepatic impair-
philic esophagitis occur. ment).
TIME/ACTION PROFILE (sleep)
tions, vitamins, or herbal products be- ROUTE ONSET PEAK DURATION
ing taken and to consult health care PO 30 min (de- unknown 7hr
professional before taking other Rx, layed by
OTC, or herbal products. food)
care professional if pregnancy is Excess sedation may persist for several days af-
planned or suspected or if breast feed- ter discontinuation.
ing. Contraindications/Precautions
Evaluation/Desired Outcomes Contraindicated in: Narcolepsy; Con-
Decreased symptoms or allergic rhinitis current use of strong inhibitors of CYP3A;
and/or conjunctivitis. Severe hepatic impairment.
Use Cautiously in: History of substance
abuse or drug dependence; Concurrent
suvorexant use of moderate inhibitors of CYP3A (dose
(soo-voe-rex-ant) precommended); Obese patients (qlev-
Belsomra els, especially in women, dosepmay be
warranted); History of or concurrent psy-
Classification chiatric diagnoses; Underlying pulmonary
Thera: sedative/hypnotics disease; OB: Use during pregnancy only if
Pharm: orexin receptor potential benefit justifies potential fetal
antagonists risk; Lactation: Use cautiously if breast
feeding; Pedi: Safe and effective use in
Schedule IV children has not been established.
Pregnancy Category C Adverse Reactions/Side Effects
Adverse reactions, especially related to
Indications CNS depression are dose-related, espe-
Treatment of insomnia associated with dif- cially at the 20 mg dose.
ficulty in sleep onset and/or maintenance. CNS: drowsiness, cataplexy, daytime
Action drowsiness, hallucinations, worsening of
Antagonizes the effects of orexins A and B, depression/suicidal ideation, sleep paraly-
naturally occurring neuropeptides that sis.
pg 77 Plate
# 1 # 0-Composite
suvorexant 77
Interactions NURSING IMPLICATIONS
Drug-Drug: Concurrent use of strong
inhibitors of CYP3A including boce-
Assessment
Assess mental status, sleep patterns, and
previr, clarithromycin, conivaptan,
potential for abuse prior to administra-
indinavir, itraconazole, ketocona-
tion. Prolonged use of 7 10 days may
zole, nefazodone, nelfinavir, posa-
lead to physical and psychological de-
conazole, ritonavir, saquinavir, tela-
pendence. Limit amount of drug avail-
previr, and telithromycin risk of
able to the patient.
excessive sedation and should be
Assess alertness at time of peak effect.
avoided. Concurrent use of moderate
Notify health care professional if de-
inhibitors of CYP3A including am-
sired sedation does not occur.
prenavir, aprepitant, atazanavir,
ciprofloxacin, diltiazem, erythromy- Potential Nursing Diagnoses
cin, fluconazole, fosamprenavir, im- Insomnia (Indications)
atinib, and verapamil may result inq Risk for injury (Side Effects)
sedation (pdose recommended). Risk Implementation
of CNS depression, next-day impairment, Before administering, reduce external
sleep-driving and other complex be- stimuli and provide comfort measures
haviors while not fully awakeqwith to increase effectiveness of medication.
other CNS depressants including alco- Protect patient from injury. Raise bed
hol, some antihistamines, opioids, side rails. Assist with ambulation. Re-
other sedative/hypnotics (including move patients cigarettes.
benzodiazepines) and tricyclic anti- Use lowest effective dose.
depressants; dose adjustments may be PO: Tablets should be swallowed whole
necessary). Concurrent use of CYP3A with full glass of water. Take no more
inducers including carbamazepine, than once/night and within 30 min of
phenytoin and rifampin maypeffec- going to bed. Take only if at least 7 hr
tiveness. May alter digoxin levels (blood remaining before awaking. For faster
level monitoring recommended). onset of sleep, do not administer with
Drug-Food: Grapefruit juice may re- or immediately after a meal.
sult inqblood levels and excess sedation
(pdose recommended). Patient/Family Teaching
Instruct patient to take suvorexant as di-
Route/Dosage rected. Advise patient not to take suvo-
PO (Adults): 10 mg within 30 minutes rexant unless able to stay in bed a full
of going to bed, if well tolerated but not night (7 hr) before being active again.
optimally effective, dose may be in- Do not take more than the amount pre-
creased next night, not to exceed 20 mg scribed because of the habit-forming
(dose may not be repeated on a single potential. Not recommended for use
night and should be when at least 7 hr of longer than 7 10 days. Instruct patient
sleep time is anticipated before planned to read Medication Guide for correct
awakening). Concurrent use of moder- product before taking and with each Rx
ate inhibitors of CYP3A 5 mg ini- refill, changes may occur.
tially, dose may beqto 10 mg if lower Because of rapid onset, advise patient to
dose is tolerated but not optimally effec- go to bed immediately after taking suvo-
tive. Lowest effective dose should be rexant.
used. May cause daytime drowsiness or dizzi-
ness. Advise patient to avoid driving or
Availability other activities requiring alertness until
Tablets: 5 mg, 10 mg, 15 mg, 20 mg. response to this medication is known.
pg 78 Plate
# 78 # 0-Composite
78 timothy grass pollen allergen extract

Caution patient that complex sleep-re- production,qspecific immunoglobulin
lated behaviors (sleep-driving) may oc- G4 (IgG4) production and changes in in-
cur while asleep. Inform families and terleukin and eosinophil activity. Thera-
advise to notify health care professional peutic Effects: Decreased symptoms
if these behaviors occur. (rhinitis/conjunctivitis) and need for daily
Instruct patient to notify health care medication to control symptoms.
professional of all Rx or OTC medica- Pharmacokinetics
tions, vitamins, or herbal products be- Absorption: Allergen is absorbed and
ing taken and to avoid concurrent use processed from oral mucosa and GI tract.
of Rx, OTC, and herbal products with-
Distribution: Unknown.
out consulting health care professional.
Caution patient to avoid concurrent use
Metabolism and Excretion: Un-
known.
of alcohol or other CNS depressants.
Advise patient to notify health care pro- Half-life: Unknown.
fessional if depression worsens or sui- TIME/ACTION PROFILE (decrease in
cidal thoughts occur. symptoms/need for medications)
fessional immediately if signs of anaphy- ROUTE ONSET PEAK DURATION
laxis (swelling of the tongue or throat, SL 12 wk unknown maintained
trouble breathing, and nausea and vom- through-
iting) occur. out pol-
len sea-
Advise female patient to notify health son
care professional if pregnancy is
planned or suspected or if breast feed- Effect may persist for more than one year fol-
ing. lowing discontinuation.
Relief of insomnia. Contraindicated in: Severe/unstable/
uncontrolled asthma; History of severe al-
timothy grass pollen munotherapy; History of eosinophilic
allergen extract esophagitis; History of hypersensitivity to
(ti-moe-thee grass po-len inactive ingredients.
al-ler-gen ex-trakt) Use Cautiously in: Oral inflammation/
Grastek wounds including oral surgery/dental ex-
traction, oral lichan planus, mouth ulcers
Classification or thrush (discontinue temporarily); Pa-
Thera: allergy, cold, and tients who may not respond to epineph-
cough remedies rine/bronchodilators including those tak-
Pharm: immunotherapy ing beta-blockers; OB: Use during
pregnancy only if clearly needed (sys-
Pregnancy Category B temic/local adverse reactions may be
poorly tolerated during pregnancy); Lac-
Indications tation: Use cautiously if breast feeding;
Treatment of timothy grass-induced aller- Pedi: Safe and effective use in children 5
gic rhinitis with/without conjunctivitis, yr has not been estblished.
confirmed by testing to be associated with Exercise Extreme Caution in: Any
the presence of pollen-specific IgE anti- medical condition that may preclude sur-
bodies. viving a serious allergic reaction.
Action Adverse Reactions/Side Effects
Small doses of antigen produce T-cell acti- CNS: fatigue, headache. EENT: ear pruri-
vation and downregulation of mucosal tus, throat irritation, dry throat, eye pruri-
mast cells; additional effects includepIgE tus, nasal discomfort, oropharyngeal pain,
pg 79 Plate
# 79 # 0-Composite
timothy grass pollen allergen extract 79

pharyngeal edema, sneezing, throat tight- throat tightness or swelling, trouble
ness. Resp: dyspnea. CV: chest discom- swallowing or sleaking, dizziness or
fort. GI: mouth edema, oral pruritus, dys- fainting, rapid or weak heartbeat, se-
pepsia, dysphagia, glossitis, glossodynia, vere stomach cramps or pain, vomiting,
lip swelling, oral hypoesthesia, oral muco- diarrhea, severe flushing or itching) for
sal erythema, oral paraesthesia, stomatitis, at least 30 min after initial dose. Keep
swollen tongue, palatal edema, tongue epinephrine, an antihistamine, and re-
pruritus. Derm: pruritus, urticaria. suscitation equipment close by in the
Misc: allergic reactions including ANA- event of an anaphylactic reaction. Dis-
PHYLAXIS/LARYNGOPHARYNGEAL RESTRICTION. continue therapy of severe allergic re-
action occurs. If persistent or escalating
Interactions reactions occur, re-evaluate therapy
Drug-Drug: Concurrent allergen im- and consider discontinuation.
munotherapy mayqrisk of adverse re- Monitor for signs and symptoms of eo-
actions. Concurrent beta blockers may sinophilic esophagitis (severe or per-
presponse to bronchodilators or paren- sistent gastro-esophageal symptoms,
teral epinephrine if required for severe al- dysphagia, chest pain). Discontinue
lergic reactions to pollen extract. Alpha therapy and consider diagnosis if symp-
blockers and beta blockers blunt the toms occur.
beneficial effects of epinephrine which Monitor for signs and symptoms of
may be required to treat anaphylaxis (q asthma attack (wheezing, coughing,
dose of epinephrine may be required). dyspnea) before administering. With-
Ergot alkaloids may reverse the pressor hold if patient experiencing acute
effects of epinephrine. Effects of epineph- asthma exacerbation. If recurrent
rine may beqby tricyclic antidepres- asthma exacerbations occur, consider
sants, levothyroxine, MAO inhibitors discontinuation of therapy.
and some antihistamines including Assess for oral inflammation (oral li-
chlorpheniramine and diphenhyra- chen planus, mouth ulcers, thrush)
mine. Cardiac glycosides mayqrisk of prior to administration. Allow healing
adverse cardiovascular events with epine- before administration.
prine.
Route/Dosage Ineffective breathing pattern (Indications)
SL (Adults and Children 5 65 yr):
One tablet daily, started at least 12 wk Implementation
Therapy should be started at least 12
prior to onset of timothy grass pollen sea-
son, continued throughout season (has wks prior to onset and throughout grass
been taken daily for three consecutive pollen season. Administer first dose in
health care setting and monitor patient
years).
for allergic reactions for at least 30 min.
Availability If no reactions occur, patient may ad-
Sublingual tablets: 2800 bioequivalent minister subsequent doses at home.
allergy units (BAUs). SL: Remove tablet from blister just
prior to dosing. Immediately place tab-
NURSING IMPLICATIONS let under tongue until complete dissolu-
Assessment tion for at least 1 min before swallow-
Assess for signs and symptoms of al- ing. Wash hands after handling tablet.
lergy (sneezing; runny or itchy nose; Patient/Family Teaching
nasal congestion; itchy, watery eyes) be- Instruct patient in correct method of
fore and periodically during therapy. taking Grastek; avoid swallowing tablet
Monitor for signs and symptoms of al- until dissolved. Avoid food or beverage
lergic reactions (trouble breathing, for 5 min after dissolution of tablet. If
pg 80 Plate
# 80 # 0-Composite
80 umclidinium
dose is missed, omit and take next Pharmacokinetics
scheduled dose next day; do not double Absorption: Minimal oral absorption;
doses. If more than 1 dose is missed, remainder of absorption occurs in lungs.
notify health care professional before Distribution: Unknown.
restarting. Explain to patient that ther- Metabolism and Excretion: Primarily
apy does not give immediate relief of al- metabolized by CYP2D6, metabolites do
lergy symptoms. Instruct patient to read not contribute to bronchodilation.
Medication Guide before starting ther- Half-life: 11 hr.
apy and with each Rx refill in case of
changes. TIME/ACTION PROFILE
Instruct patient in how and when to use
autoinjectable epinephrine and to seek
(bronchodilation)
immediate medical care if used. ROUTE ONSET PEAK DURATION
Advise patient to stop therapy notify inhaln 1 hr 212 hr 24 hr
health care professional if signs and
symptoms of allergic reactions, asthma Contraindications/Precautions
attack, oral inflammation, or eosino- Contraindicated in: Severe/acute
philic esophagitis occur. symptoms of airflow obstruction; Severe
Instruct patient to notify health carehypersensitivity to milk proteins or other
professional of all Rx or OTC medica- ingredients; Concurrent use with other an-
tions, vitamins, or herbal products be-
ticholinergics; Lactation: Discontinue drug
ing taken and to consult health care or discontinue breast feeding.
professional before taking other Rx, Use Cautiously in: Narrow-angle glau-
OTC, or herbal products. coma (may cause acute angle closure);
Advise female patient to notify healthUrinary retention, prostatic hyperplasia,
care professional if pregnancy is bladder-neck obstruction; Severe hepatic
impairment; Geri: Elderly patients may be
ing. more sensitive to drug effects; OB: Use
Evaluation/Desired Outcomes during pregnancy only if potential benefit
Decreased symptoms or allergic rhinitis justifies potential fetal risk; Pedi: Safe and
and/or conjunctivitis. effective use in children has not been es-
tablished.
umclidinium Adverse Reactions/Side Effects
(ue-mek-li-din-ee-um) EENT: acute narrow-angle glaucoma,
Incruse Ellipta cough, nasopharyngitis. Resp: PARADOXI-
CAL BRONCHOSPASM. CV: chest pain. GU:
Classification urinary retention. MS: arthralgia.
Thera: bronchodilators
Pharm: anticholinergics Interactions
Drug-Drug:qrisk of adverse anticho-
Pregnancy Category C linergic adverse reactions when used con-
currently with other anticholinergics
Indications (avoid concurrent use).
Maintenance management of airflow ob-
struction in patients with COPD. Route/Dosage
Inhaln (Adults): One inhalation (62.5
Action mcg) once daily.
Acts as an anticholinergic by inhibiting M3
muscarinic receptors in bronchial smooth Availability
muscle resulting in bronchodilation. Powder for inhalation in blister
Therapeutic Effects: Bronchodilation strips (contains lactose): 62.5 mcg/
with decreased airflow obstruction. blister.
pg 81 Plate
# 81 # 0-Composite
vedolizumab 81
NURSING IMPLICATIONS ening narrow-angle glaucoma (eye pain
or discomfort, blurred vision, visual ha-
Assessment los, colored images associated with red
Assess respiratory status (rate, breath dyes from conjunctival congestion, cor-
sounds, degree of dyspnea, pulse) be- neal edema) or worsening urinary re-
fore administration and at peak of med- tention (difficulty passing urine, painful
ication. Consult health care professional urination) occur.
about alternative medication if severe Advise female patient to notify health
bronchospasm is present; onset of ac- care professional if pregnancy is
tion is too slow for patients in acute dis- planned or suspected or if breast feed-
tress. If paradoxical bronchospasm ing.
(wheezing) occurs, withhold medica-
tion and notify health care professional Evaluation/Desired Outcomes
immediately. Decrease in the number of flare-ups or
the worsening of COPD symptoms (ex-
Potential Nursing Diagnoses acerbations).
Ineffective airway clearance (Indications)
Risk for activity intolerance (Indications)
Implementation vedolizumab
Inhaln: Follow manufacturers instruc- (ve-doe-liz-yoo-mab)
tions for use of inhaler. Breathe out; do Entyvio
not blow into mouthpiece. Close lips Classification
around mouthpiece. Breathe in a long,
steady deep breath. Continue to hold Thera: gastrointestinal
breath as long as possible while remov- anti-inflammatories
ing inhaler from mouth. Slide cover Pharm: monoclonal anti-
over mouthpiece. bodiesintegrin receptor an-
Patient/Family Teaching tagonists
Instruct patient in the correct use of in-
haler. Advise patient not to discontinue Pregnancy Category B
without consulting health care profes-
sional; symptoms may recur. Indications
Inform patient that umeclidinium is not Moderately to severely active ulcerative
a bronchodilator and should not be colitis or Crohns disease that has not re-
used for treating sudden breathing sponded adequately to/lost response to/
problems. become intolerant to tumor necrosis fac-
Advise patient to notify health care pro- tor (TNF) blockers or immunomodula-
fessional if worsening symptoms; de- tors; or has become intolerant to/depend-
creasing effectiveness of inhaled, short- ant on corticosteroids and failed to
acting beta2 agonists; need for more induce/maintain beneficial response/re-
inhalations than usual of inhaled, short- mission, improved endoscopic appear-
acting beta2 agonists; or significant de- ance (ulcerative colitis) or achieved corti-
crease in lung function occur. costeroid-free remission.
Instruct patient to notify health care Action
professional of all Rx or OTC medica- A monoclonal antibody that binds to cer-
tions, vitamins, or herbal products be- tain integrins, blocking their interaction
ing taken and to avoid concurrent use with substances involved in mucosal cell
of Rx, OTC, and herbal products with- adhesion, also inhibits migration of mem-
out consulting health care professional. ory T-lymphocytes across endothelium
Advise patient to notify health care pro- into inflamed GI tissue. Therapeutic Ef-
fessional if signs and symptoms of wors- fects: Decreased chronic GI inflamma-
pg 82 Plate
# 82 # 0-Composite
82 vedolizumab
tion and symptomatology associated with Availability
ulcerative colitis and Crohns disease. Lyophilized powder for injection (re-
quires reconstitution and further di-
Pharmacokinetics lution): 300 mg in 20 mL single-use vial.
Absorption: IV administration results in
complete bioavailability.
Distribution: Unknown. NURSING IMPLICATIONS
Metabolism and Excretion: Un- Assessment
known. Assess abdominal pain and frequency,
Half-life: 25 days. quantity, and consistency of stools at
beginning and during therapy.
TIME/ACTION PROFILE (clinical Assess for signs of hypersensitivity or in-
improvement) fusion-related reactions (dyspnea,
bronchospasm, urticaria, flushing,
ROUTE ONSET PEAK DURATION rash, swelling of lips, tongue, throat, or
IV within 6 wk unknown up to 8 wk face, wheezing, hypertension, tachycar-
dia). If anaphylaxis or serious allergic
Contraindications/Precautions reactions occur, discontinue vedoli-
Contraindicated in: Hypersensitivity; zumab and treat symptoms.
Active severe infection; Live-virus vaccina- Assess for new signs or symptoms sug-
tions; Concurrent use of natalizumab; gestive of progressive multifocal leuko-
Concurrent use of TNF blockers. encephalopathy (PML), an opportunis-
Use Cautiously in: OB: Use during tic infection of the brain caused by the
pregnancy if maternal benefits outweigh JC virus, leading to death or severe dis-
risk to the unborn child; Lactation: Use ability; withhold dose and notify health
cautiously if breast feeding; Pedi: Safe and care professional promptly. Monitor
effective use in children has not been es- during therapy and for at least 6 mo fol-
tablished. lowing discontinuation. PML symptoms
may begin gradually but usually over
Adverse Reactions/Side Effects days to wk and leads to death or severe
CNS: headache, fatigue. Resp: cough. disability over wk to mo. Symptoms in-
GI: oropharyngeal pain,qtransaminases. clude progressive weakness on one side
Derm: pruritus, rash. MS: arthralgia, of body or clumsiness of limbs, distur-
back pain, extremity pain. Misc: fever, bance of vision, changes in thinking,
hypersensitivity reactions including ANA- memory and orientation leading to con-
PHYLAXIS,qrisk of infection.. fusion and personality changes. Diagno-
sis is usually made via gadolinium-en-
Interactions hanced MRI and CSF analysis. Withhold
Drug-Drug: Maypantibody response to vedolizumab at first sign of PML.
andqrisk of adverse reactions from live- Lab Test Considerations: May
virus vaccines (complete immunizations causeqAST, ALT, and serum bilirubin.
prior to treatment). Concurrent use with Discontinue in patients with jaundice or
natalizumab mayqrisk of infections and other evidence of liver injury.
Progressive Multifocal Leukoencephalopa-
thy and should be avoided. Concurrent Potential Nursing Diagnoses
use with TNF blockers mayqrisk of in- Risk for infection (Adverse Reactions)
fections and should be avoided.
Implementation
Route/Dosage Perform test for latent TB. If positive,
IV (Adults): 300 mg wk zero, two and begin treatment for TB prior to starting
six, then every 8 wk; treatment may be vedolizumab therapy. Monitor for TB
continued if beneficial response is ob- throughout therapy, even if latent TB
tained by wk 14. test is negative.
pg 83 Plate
# 83 # 0-Composite
vedolizumab 83
IV Administration confusion and personality changes), hy-
Intermittent Infusion: Reconstitute persensitivity reactions, hepatotoxicity
with 4.8 mL Sterile Water for Injection (yellowing of the skin and eyes, unusual
using 21 to 25 gauge needle. Direct darkening of the urine, anorexia, nau-
stream to wall of vial to prevent exces- sea, feeling tired or weak, vomiting,
sive foaming. Gently swirl vial for at right upper abdominal pain), or wors-
least 15 seconds to dissolve; do not in- ening of symptoms (new or sudden
vert of shake vigorously. Allow to sit for change in your thinking, eyesight, bal-
up to 20 min at room temperature for ance, or strength or other problems)
reconstitution and settling of foam. If that persist over several days to health
not fully dissolved after 20 min, allow care professional immediately.
another 10 min. Do not use vial if not Inform patient of risk of infection. Ad-
dissolved within 30 min. Solution is vise patient to notify health care profes-
clear or opalescent, colorless to light sional if symptoms of infection (fever,
brownish yellow; do not administer so- chills, muscle aches, shortness of
lutions that are discolored or contain breath, runny nose, cough, sore throat,
particulate matter. Swirl gently and in- red or painful skin or open cuts or
vert vial 3 times prior to withdrawing. sores, tiredness, pain during urination)
Withdraw 5 mL (300 mg) using 21 to occur.
25 gauge needle. Discard unused por- Advise patient to notify health care pro-
tion. Diluent: 250 mL 0.9% NaCl. fessional of all Rx or OTC medications,
Gently mix bag. Use as soon as possible. vitamins, or herbal products being
Stable up to 4 hrs if refrigerated; do not taken and to consult with health care
freeze. Flush line with 30 mL of 0.9% professional before taking other medi-
NaCl after infusion. Rate: Infuse over cations.
30 min; do not administer as IV push or Advise female patient to notify health
bolus. care professional if pregnancy is
Y-Site Incompatibility: Do not ad- planned or suspected or if breast feed-
minister with other solutions or medi- ing. Encourage pregnant women to join
cations. Entyvio Pregnancy Registry by calling 1-
877-825-3327. Registry monitors preg-
Patient/Family Teaching nancy outcomes in women exposed to
Explain purpose of vedolizumab to pa-
vedolizumab during pregnancy.
tient. Advise patient to read Medication
Guide prior to therapy. Evaluation/Desired Outcomes
Instruct patient to report symptoms of Decreased chronic GI inflammation and
PML (progressive weakness on one side symptomatology associated with ulcera-
of the body or clumsiness of limbs; dis- tive colitis and Crohns disease. Discon-
turbance of vision; changes in thinking, tinue therapy if no improvement by
memory, and orientation leading to Week 14.

Table 1 Drugs With New Warnings
84
Generic Name (Brand Name) Warning
acne medications containing benzoyl peroxide or salicylic acid (Proactiv, Neutro- Rare, serious potentially life-threatening allergic reactions/severe irritation. Before first applica-
gena, MaxClarity, Oxy, Ambi, Aveeno, Clean & Clear and others) tion, users should apply a small amount to one or two small affected areas daily for 3 days. If no
discomfort occurs, product can be used according to directions.
bendamustine (Treanda) An ingredient in the bendamustine formulation is incompatible with closed system transfer de-
vices/adaptors/syringes containing polycarbonate or acrylonitrile-butadiene-styrene; may result in
device failure and/or potentially serious adverse reactions including small vessel blockage in pa-
tients and skin reactions in health care providers who come in contact with preparations.
corticosteroids, injectable, epidural (methylprednisolone, hydrocortisone, triam- Rare but q risk of serious adverse neurologic adverse events, including loss of vision, stroke, pa-
cinolone, betamethasone, and dexamethasone) ralysis, and death following epidural administration.
docetaxel (Docefrez, Taxotere) Presence of ethanol in preparations may lead to signs of alcohol intoxication following adminis-
tration.
doripenem (Doribax) q risk of death in ventilator patients with pneumonia.
Name /bks_53956_deglin_diu2016/53956_bm
lidocaine viscous solution 2% (Xyocaine, Viscous) Should not be used to treat teething pain in infants/children. Excess amounts may be accidentally
ingested resulting in life-threatening seizures, severe brain injury, and cardiac events.
omalizumab (Xolair) q risk of heart and brain blood vessel problems including TIAs, MIs, chest pain, pulmonary hy-
pertension and thromboembolic phenomena.
phosphate/biphosphate (Fleet Enema, OsmoPrep, Visicol) also known as sodium Using 1 dose/24 hr may rarely cause serious harm to kidneys and heart, and even death. Avoid
phosphate laxative preparations oral products in children ≤5 yr without health care provider recommendation. Rectal form
should never be given to children 2 yr. q risk in young children, individuals 55 yr, concur-
rent dehydration, renal disease, bowel obstruction/inflammation or concurrent use of diuretics,
angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs), and
NSAIDs.
03/26/2015 08:03AM pgPlate
84 ## 10-Composite
Table 1 (Continued)
saxagliptin (onglyza) q risk of HF.
sildenafil (Revatio) Pediatric precaution is not a contraindication, but a warning that chronic use at higher doses in
children may be associated with q mortality; use in children should be undertaken with great cau-
tion.
testosterone (Androgel, Aveed, Axiron, Delatestryl, Depo-Testosterone, Foresta, May q risk of heart attack and stroke.
Natesto, Striant, Testim, Testopel)
varenicline (Chantix) q risk of intoxication with alcohol (may result in q aggression or insomnia). q risk of seizures.
ziprasidone (Geodon) May rarely cause Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), a serious skin
reaction that can affect lymph nodes, liver, kidney, lungs, heart, or pancreas.
85
03/26/2015 08:03AM pgPlate
85 ## 20-Composite
Table 2 Drugs with New Dosage Forms or Strengths
86
Generic Name (Brand Name) New dosage form or strength
budenoside (Uceris) Rectal aerosol foam 2 mg/actuation.
buprenorphine/naloxine (Bunavail) Buccal film buprenorphine 2.1 mg/naloxone 0.3 mg, buprenorphine 4.2 mg/naloxone 0.4 mg, buprenor-
phine 6.3 mg/naloxone 1 mg (citrus flavor).
burenorphine/naloxone (Zubsolv) Sublingual tablets buprenorphine 8.6 mg/naloxone 2.1 mg, buprenorphine 11.4 mg/naloxone 2.9 mg (men-
thol flavor).
colchicine (Mitigare) Capsules 0.6 mg.
carbidopa/levodopa (Duopa) Enteral suspension formulation carbidopa 4.63 mg and levodopa/20 mg/mL.
carbidopa/levodopa (Rytary) Extended-release capsules carbidopa 23.75 mg/levodopa 95 mg, carbidopa 36.25mg/levodopa 145 mg, car-
bidopa 48.75 mg/levodopa 195 mg, carbidopa 61.25 mg/levodopa 245 mg.
dantrolene (Ryanodex) Powder for IV suspension 250 mg /single-use vial.
diclofenac (Dyloject) Solution for IV injection 37.5 mg/mL single-use vial.
estradiol (Minivelle) Transdermal patch (0.025 mg/day).

fluocinolone (Iluvien) Intravitreal implant 0.19 mg.
fluticasone (Arnuity Ellipta) Powder for inhalation 0.1 mg/inhalation, 0.2 mg/inhalation.
hydrocodone (Hysingla) Extended-release tablets 30 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg.
indomethacin (Tivorbex) Capsules 20 mg, 40 mg.
influenza vaccine, quadravalent (Fluzone) Intradermal dose form.
insulin glargine [rDNA origin] (Tuojeo) 300 units/mL in 1.5 mL prefilled pen.
03/26/2015 08:03AM pgPlate
86 ## 30-Composite
Table 2 (Continued)
ivermectin (Soolantra) Topical cream 1%.
levetiracetam (Elepsia XR) Extended-release tablets 1000 mg, 1500 mg.
mercaptopurine (Purixan) Oral suspension 20 mg/mL (raspberry flavor).
methotrexate (Rasuvo) Solution for subcut injection in pre-filled auto-injector 7.5 mg/0.15 mL, 10 mg/0.2 mL, 12.5mg/0.25 mL, 15
mg/0.3 mL, 17.5 mg/0.35 mL, 20 mg/0.4 mL, 22.5 mg/0.45 mL, 25 mg/0.5 mL, 27.5 mg/0.55 mL, and 30 mg/
0.6 mL.
naloxone (Evzio) Solution for IM or subcut injection in pre-filled auto-injector 0.4 mg/0.4 mL.
omega-3-carboxylic acids (Epanova) Capsules 1 g (contains 850 mg polyunsaturated fatty acids).
omega-3-acid ethyl esters (Omtryg) Capsules 1.2 g (contains at least 900 mg ethyl esters of omega-3 fatty acids).
pasireotide (Signifor LAR) IM injectable suspension 20 mg, 40 mg, 60 mg (powder for reconstitution with 2 mL diluent).
phenylephrine (Vazculep) Solution for IV infusion 10 mg/mL.
posaconazole (Noxafil) Delayed-release oral tablets 100 mg.

Solution for IV infusion 300 mg/16.7 mL.
propranolol (Hemangeol) Oral solution 4.28 mg/mL (strawberry-vanilla flavor).
sotalol (Sotylize) Oral solution 5 mg/mL (grape flavor).
testosterone (Natesto) Nasal gel in metered-dose pump (5.5 mg/pump).
testosterone undecanoate (Aveed) Long-acting IM injection 750 mg/3 mL.
testosterone (Vogelxo) Topical gel 50 mg/unit-dose tube, 50 mg/unit-dose packet, 12.5 mg/actuation of metered-dose pump.
tiotropium (Spiriva) Inhalation spray 2.5 mcg tiotropium /actuation with RESPIMAT inhaler.
topiramate (Qudexy XR) Extended-release capsules 25 mg, 50 mg, 100 mg, 150 mg, 200 mg.
87
03/26/2015 08:03AM pgPlate
87 ## 40-Composite
Table 3 Drugs with New Indications
88
Generic Name (Brand Name) New Indication
adalimumab (Humira) Pediatric patients with Crohns Disease.
alglucosidase alfa (Lumizyme) Pompe Disease patients of all ages.
apixaban (Eliquis) p risk of blood clots after hip/knee replacement.
Deep vein thrombosis/pulmonary embolism.
asparaginase Erwinia chrysanthemi (Erwinaze) Intravenous use.
bevacizumab (Avastin) Platinum-resistant recurrent ovarian cancer (with other chemotherapy).
Cervical cancer.
dabigatran (Pradaxa) Capsules Deep vein thrombosis/pulmonary embolism.
denosumab (Xgeva) Hypercalcemia of malignancy refractory to bisphosphonates.
diclofenac (Zorvolex) Osteoarthritis pain.
ecallantide (Kalbitor)
Treatment of HAE in patients 12 yr.

eltrombopag (Promacta) Severe Aplastic Anemia.
esomeprazole (Nexium 24HR) OTC use for frequent heartburn.
estradiol trandermal patch (Minivelle) Prevention of osteoporosis (0.025 mg/day patch only).
fluticasone nasal spray (Flonase Allergy Relief) OTC use for allergic rhinitis.
lanreotide (Somatuline Depot) Gastroenteropancreatic neuroendocrine tumors.
lenalidomide (Revlimid) Newly diagnosed Multiple Myeloma (with dexamethasone).
liraglutide (Saxagliptin) Weight loss.
lisdexamfetamine (Vyvanse) Binge-eating disorder.
nivolumab (Opdivo) Advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemo-
therapy.
03/26/2015 08:03AM pgPlate
88 ## 50-Composite
Table 3 (Continued)
omalizumab (Xolair) Chronic idiopathic urticaria.
propranolol (Hemangeol) Proliferating infantile hemangioma.
ramucirumab (Cyramza) Aggressive non-small cell lung cancer.
rifapentine (Priftin) Latent tuberculosis.
rufinamide (Banzel) Adjunctive anti-epileptic in pediatric patients.
simeprevir (Olysio) With sofosbuvir for Genotype 1 Chronic Hepatitis C Infection.
tbo-filgrastim (Granix) Approved for self-administration/administration by caregiver.
topiramate (Topomax) Migraine prophylaxis in adolescents 1217 yr.
Table 4 New Drug Combinations

Brand name Components, Dosages, and Indications

atazanavir/cobicistat (Evotaz) tablets atazanavir 300 mg cobicistat 150 mg
Combination antiretroviral for HIV.
benzoyl peroxide/clindamycin (Onexton) topical gel benzoyl peroxide 3.75% clindamycin 1.2%
Acne.
canagliflozin/metformin (Invokamet) tablets canagliflozin 50 mg metformin 500 mg
canagliflozin 50 mg metformin 1 g
canagliflozin 150 mg metformin 500 mg
canagliflozin 150 mg metformin 1 g
Type 2 diabetes mellitus.
ceftazidime/avibactam (Avycaz) powder for injection ceftazidime 2 g avibactam 0.5 g
Combination anti-infective for complicated intra-abdominal infections.
89
03/26/2015 08:03AM pgPlate
89 ## 60-Composite
Table 4 (Continued)
90
cobicistat/darunavir (Prezcobix) tablets cobicistat 150 mg darunavir 800 mg
dapagliflozin/metformin (Xigduo XR) Extended-release tablets dapagliflozin 5 mg metformin 500 mg
dapagliflozin 5 mg metformin 1 g
dapagliflozin 10 mg metformin 500 mg
dapagliflozin 10 mg metformin 1 g
dasabuvir/ombitasvir/paritaprevir/ritonavir (Viekira Pak) tablets ombitasvir 12.5 mg paritaprevir 75 mg ritonavir 50 mg tablets with dasabuvir 250 mg tablets in a conve-
nience pak
donepezil/memantine (Namzaric) capsules donepezil 10 mg memantine extended-release 14 mg
donepezil 10 mg memantine extended-release 28 mg
Dementia of the Alzheimers type.
empagliflozin/linagliptin (Glyxambi) tablets empagliflozin 10 mg linagliptin 5 mg
empagliflozin 25 mg linagliptin 5 mg
hydrocodone/guaifenesin (Obredon) Oral Solution hydrocodone 2.5 mg guaifenesin 200 mg/5 mL (raspberry or cherry punch flavor)
Antitussive/expectorant for patients 18 yr.
lamivudine/raltegravir (Dutrebis) tablets lamivudine 150 mg raltegravir 325.8 mg
ketorolac/phenylephrine (Omidria) injection 0.3% ketorolac 1% phenylephrine
Irrigation additive during cataract surgery/intraocular lens replacement.
oxycodone/acetaminophen (Xartemis XR) extended-release tablets oxycodone 7.5 mg acetaminophen 325 mg
opioid analgesic nonopioid analgeisic
03/26/2015 08:03AM pgPlate
90 ## 70-Composite
Table 4 (Continued)
oxycodone/naloxone (Targiniq ER) extended-release tablets oxycodone 10 mg naloxone 5 mg
oxycodone 20 mg naloxone 10 mg
oxycodone 40 mg naloxone 20 mg
Opioid analgesic abuse deterrent
Table 5 Other Recently Released Drugs
Generic Name (Brand Name) Indication

aflibercept intravitreal injection (Eylea) Macular edema.
isavuconazonium (Cresemba) Invasive aspergillosis or mucormycosis.
dinutuximab (Unituxin) High-risk neuroblastoma in pediatric patients.
filgrastim-sndz (Zarxio) Neutropenia (bioequivalent to filgrastim).
metreleptin subcutaneous injection (Myalept) Leptin deficiency.

panobinostat (Farydak) Multiple myeloma.
parathyroid hormone subcutaneous injection (Natpara) Hypoparathyroidism.
siltuximab lyophilized powder for intravenous infusion (Sylvant) Multicentric Castlemans disease.
vorapaxar (Zontivity) Reduction of cardiovascular events in patients with a history of MI or peripheral arterial disease (PAD);
can be used with aspirin and/or clopidogrel.
Table 6 Discontinued Drugs
Generic Name (Brand Name) Reason for Discontinuation

There have been no discontinued drugs in 2014 or 2015.
91
03/26/2015 08:03AM pgPlate
91 ## 80-Composite

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Name /bks_53956_deglin_diu2016/53956_fm 03/26/2015 02:15PM pg

APRIL HAZARD VALLERAND, CYNTHIA A. SANOSKI, BS, PharmD,

JUDITH HOPFER DEGLIN, PharmD

2016 DRUG INFORMATION UPDATE

Keep up-to-date at www.DrugGuide.com

Table 1 Drugs with New Warnings, 84 Table 4 New Drug Combinations, 89

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DG14E _DIU House Ad_2015.indd 1 3/20/15 11:03 AM

antihemophilic factor (recombinant) Fc fusion protein 1

2 antihemophilic factor (recombinant) Fc fusion protein

C1-esterase inhibitor, recombinant 7

8 C1-esterase inhibitor, recombinant

coagulation factor IX (Recombinant), Fc fusion protein 11

12 coagulation factor XIII A-subunit (recombinant)

insulin, human inhalation 35

36 insulin, human inhalation

insulin, human inhalation 37

Potential Nursing Diagnoses Indications

lipid emulsion, injectable 43

44 lipid emulsion, injectable

meningococcal group B vaccine 47

48 mixed pollens allergen extract

mixed pollens allergen extract 49

74 short ragweed pollen allegen extract

Evaluation/Desired Outcomes Contraindications/Precautions

short ragweed pollen allegen extract 75

78 timothy grass pollen allergen extract

timothy grass pollen allergen extract 79

Canadian drug name. Genetic implication.

estradiol (Minivelle) Transdermal patch (0.025 mg/day).

posaconazole (Noxafil) Delayed-release oral tablets 100 mg.

Treatment of HAE in patients 12 yr.

Table 4 New Drug Combinations

Brand name Components, Dosages, and Indications

Table 5 Other Recently Released Drugs

Generic Name (Brand Name) Indication

metreleptin subcutaneous injection (Myalept) Leptin deficiency.

Table 6 Discontinued Drugs

Generic Name (Brand Name) Reason for Discontinuation

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