Dosing & Uses
Dosage Forms & Strengths
lyophilized powder for injection
- 50mg single-dose vial
injection solution
- 25mg/mL in 2 mL single-dose vial
Chronic Lymphocytic Leukemia (CLL)
Single-agent therapy
- Indicated for treatment of B-cell CLL in adults who have not responded to or whose disease has progressed during treatment with ≥1 alkylating-agent containing regimen
- 25 mg/m2 IV daily on Days 1-5 of each 28-day cycle
Combination therapy
- Indicated in combination with cyclophosphamide and rituximab for treatment of B-cell CLL
- 25 mg/m2 IV daily on Days 1-3 PLUS
- Cyclophosphamide 250 mg/m2 IV daily on Days 1-3 AND
- Rituximab 375 mg/m2 IV on Day 1 of Cycle 1, then 500 mg/m2 on Day 1 of subsequent cycles
- Repeat every 28 days for 6 cycles or until unacceptable toxicity or disease progression
- Refer to cyclophosphamide and rituximab prescribing information for additional dosing information
Dosage Modifications
Renal impairment
- CrCl 50-79 mL/min: Reduce dose to 20 mg/m2 IV
- CrCl 30-49 mL/min: Reduce dose to 15 mg/m2 IV
- CrCl <30 mL/min: Dosage not established
Hepatic impairment
- Not studied
Safety and efficacy not established
Interactions
Interaction Checker
No Results
Contraindicated
Serious
Significant - Monitor Closely
Minor
Contraindicated (1)
- pentostatin
fludarabine, pentostatin. Either increases toxicity of the other by unknown mechanism. Contraindicated. Risk of pulmonary toxicity.
Serious (13)
- adenovirus types 4 and 7 live, oral
fludarabine decreases effects of adenovirus types 4 and 7 live, oral by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressives may diminish therapeutic effects of vaccines and increase risk of adverse effects (increased risk of infection). Live-attenuated vaccines should be avoided for at least 3mo after cessation of immunosuppressive therapy.
- axicabtagene ciloleucel
fludarabine, axicabtagene ciloleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- brexucabtagene autoleucel
fludarabine, brexucabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- ciltacabtagene autoleucel
fludarabine, ciltacabtagene autoleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- etrasimod
etrasimod, fludarabine. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Risk of additive immune system effects with etrasimod has not been studied in combination with antineoplastic, immune-modulating, or noncorticosteroid immunosuppressive therapies. Avoid coadministration during and in the weeks following administration of etrasimod. .
- idecabtagene vicleucel
fludarabine, idecabtagene vicleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- influenza virus vaccine quadrivalent, adjuvanted
fludarabine decreases effects of influenza virus vaccine quadrivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- influenza virus vaccine trivalent, adjuvanted
fludarabine decreases effects of influenza virus vaccine trivalent, adjuvanted by pharmacodynamic antagonism. Avoid or Use Alternate Drug. Immunosuppressive drugs may reduce the immune response to influenza vaccine.
- lisocabtagene maraleucel
fludarabine, lisocabtagene maraleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- palifermin
palifermin increases toxicity of fludarabine by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hrbefore, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, fludarabine. Either increases toxicity of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Myelosuppressive agents can produce additive myelosuppression. Avoid use and monitor patients receiving the combination for effects of excessive myelosuppression.
- tisagenlecleucel
fludarabine, tisagenlecleucel. Either increases effects of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
- tofacitinib
fludarabine, tofacitinib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug.
Monitor Closely (19)
- acalabrutinib
acalabrutinib, fludarabine. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration may increase risk of myelosuppressive effects.
- belatacept
belatacept and fludarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor.
- cholera vaccine
fludarabine decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- dengue vaccine
fludarabine decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- denosumab
fludarabine, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.
- dichlorphenamide
dichlorphenamide, fludarabine. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Both drugs can cause metabolic acidosis.
- fingolimod
fludarabine increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .
- hydroxyurea
fludarabine, hydroxyurea. Other (see comment). Use Caution/Monitor. Comment: Combination may increase risk of myelosuppression.
- influenza A (H5N1) vaccine
fludarabine decreases effects of influenza A (H5N1) vaccine by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- influenza A (H5N1) vaccine, adjuvanted
fludarabine decreases effects of influenza A (H5N1) vaccine, adjuvanted by Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Immunosuppressive therapies may reduce immune response to H5N1 vaccine.
- meningococcal group B vaccine
fludarabine decreases effects of meningococcal group B vaccine by pharmacodynamic antagonism. Use Caution/Monitor. Individuals with altered immunocompetence may have reduced immune responses to the vaccine.
- ofatumumab SC
ofatumumab SC, fludarabine. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.
- olaparib
fludarabine and olaparib both increase pharmacodynamic synergism. Use Caution/Monitor. Coadministration with other other myelosuppressive anticancer agents, including DNA damaging agents, may potentiate and prolongate the myelosuppressive toxicity.
- siponimod
siponimod and fludarabine both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- sipuleucel-T
fludarabine decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- tobramycin inhaled
tobramycin inhaled and fludarabine both increase nephrotoxicity and/or ototoxicity. Modify Therapy/Monitor Closely. Avoid concurrent or sequential use to decrease risk for ototoxicity
- trastuzumab
trastuzumab, fludarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- trastuzumab deruxtecan
trastuzumab deruxtecan, fludarabine. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy. .
- ublituximab
ublituximab and fludarabine both increase immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Owing to potential additive immunosuppressive effects, consider duration of effect and mechanism of action of these therapies if coadministered
Minor (4)
- maitake
maitake increases effects of fludarabine by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- taurine
fludarabine decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
- vitamin A
vitamin A, fludarabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin A enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
- vitamin E
vitamin E, fludarabine. Mechanism: pharmacodynamic synergism. Minor/Significance Unknown. Antioxidants such as vitamin E enhance the efficacy, and reduce toxicity, of antineoplastic drugs.
Adverse Effects
>10%
Fever (69%)
Objective weakness (65%)
Anemia (60%)
Neutropenia (60%)
Thrombocytopenia (55%)
Leukopenia (partly therapeutic)
Infection (44%-not necessarily drug-induced)
Cough (44%)
Pain (44%)
Fatigue (38%)
N/V (36%)
Anorexia (34%)
Malaise (22%)
Dyspnea (22%)
Pneumonia (9-22%)
Edema (19%)
Myalgia (16%)
URI (16%)
UTI (15%)
Rash (15%)
Diarrhea (15%)
Visual disturbances (15%)
Diaphoresis (13%)
GI bleeding (13%)
Paresthesia (12%)
1-10% (selected)
Abdominal pain (10%)
Back pain (9%)
Headache (9%)
Pharyngitis (9%)
Stomatitis (9%)
Flu like syndrome (5-9%)
Malaise (6%)
Angina (6%)
Hearing Loss (2-6%)
Peripheral edema (7%)
Alopecia (3%)
Constipation (1-3%)
Arrhythmia (3%)
DVT (1%)
Warnings
Black Box Warnings
The drug should be administered under the supervision of an experienced cancer chemotherapy physician
Bone marrow suppression may occur. Fludarabine has been associated with severe neurologic effects, including blindness, coma when high doses were used in patients with acute leukemia. Agitation, coma, confusion, and seizures have been reported in patients treated at recommended doses for the treatment of chronic lymphocytic leukemia
If one or more cycles of treatment with fludarabine administered, autoimmune phenomena including acquired hemophilia, autoimmune thrombocytopenia/thrombocytopenic purpura, Evan syndrome, and hemolytic anemia may occur. Monitor patients closely for hemolysis
Fludarabine in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia is not recommended due to a high incidence of fatal pulmonary toxicity
Contraindications
Hypersensitivity
Concomitant pentostatin: risk of fatal pulmonary toxicity
IV: severe renal impairment
Cautions
Bone marrow depression, renal impairment, elderly
Allopurinol and hydration recommended for patients newly diagnosed with CLL or those at risk of tumor lysis syndrome
Very high doses (and rarely, normal doses) have caused irreversible or fatal neurotoxicity manifesting after 21-60 days
Risk of potentially fatal autoimmune hemolytic anemia
Avoid pregnancy
No efficacy in children
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Peak plasma time: 2 hr
Vd: 96-98 L/sq.meter
Protein bound: 19-29%
Metabolites: 2-fluoro-ara-ATP
Clearance: 8.9 L/hr/sq.meter
Excretion: urine
Mechanism of Action
Fluorinated purine analog, inhibits DNA polymerase alpha
Administration
IV Preparation
Follow applicable special handling and disposal procedures for hazardous drugs
Inspect reconstituted vials and diluted admixtures visually for particulate matter or discoloration
Reconstitution
- Add 2 mL sterile water for injection to vial containing lyophilized solid cake for final concentration of 25 mg/mL
- Lyophilized cake should fully dissolve in ≤15 seconds
Dilution
- Withdraw appropriate dosage volume from vial and further dilute in 100-125 mL of 5% dextrose injection or 0.9% sodium chloride injection
IV Administration
Administer as IV infusion over 30 minutes
Do not mix with other drugs
Storage
Lyophilized powder vials
-
Unopened vials
- Room temperature at 20-25ºC (68-77ºF)
- Excursions of 15-30°ºC (59-86ºF) permitted
- Store in original package
-
Reconstituted vials
- Use within 8 hours following reconstitution
- Contains no antimicrobial preservative; discard unused portion in vial
Solution vials
-
Unopened vials
- Refrigerate at 2-8°C (36-46°F)
-
Opened vials
- Use within 8 hours after opening
- Contains no antimicrobial preservative; discard unused portion in vial
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| fludarabine intravenous - | 50 mg/2 mL vial |  | |
| fludarabine intravenous - | 50 mg/2 mL vial |  | |
| fludarabine intravenous - | 50 mg vial |  | |
| fludarabine intravenous - | 50 mg vial |  | |
| fludarabine intravenous - | 50 mg/2 mL vial |  | |
| fludarabine intravenous - | 50 mg/2 mL vial |  | |
| fludarabine intravenous - | 50 mg/2 mL vial |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
fludarabine intravenous
FLUDARABINE - INJECTION
(flew-DARE-uh-bean)
COMMON BRAND NAME(S): Fludara
USES: This medication is used to treat leukemia and other cancers. It works by slowing or stopping the growth of cancer cells.
HOW TO USE: This medication is given by a health care professional. It is injected slowly into a vein over 30 minutes.The dosage is based on your medical condition, body size, and response to treatment. Your doctor will check your blood counts to make sure you can receive your next cycle. Keep all medical/lab appointments.If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water, then get medical help right away.
SIDE EFFECTS: Nausea, vomiting, diarrhea, headache, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Many people using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth often with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, fast/irregular heartbeat, swelling ankles/feet.Fludarabine may rarely cause severe (sometimes fatal) central nervous system problems. Symptoms may not occur until weeks after your last treatment. Tell your doctor right away if you notice any vision changes, seizures, agitation, confusion, or numbness/tingling.This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).Fludarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, your doctor may add a medication and tell you to drink plenty of fluids. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), signs of kidney problems (such as painful urination, pink/bloody urine, change in the amount of urine), muscle spasms/weakness.Get medical help right away if you have any very serious side effects, including: cough that doesn't go away, bloody/black/tarry stool, coughing up blood, painful/difficult breathing, chest pain.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections, certain virus illnesses (herpes, chickenpox), blood disorders (such as anemia, clotting problems), kidney problems.Tell your health care professional that you are using fludarabine before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).Fludarabine can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Older adults may be at greater risk for side effects (such as infection, bleeding) while using this drug.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using fludarabine. Fludarabine may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Women using this medication should ask about reliable forms of birth control during treatment and for 6 months after the last dose. Men using this medication should ask about reliable forms of birth control during treatment and for some time after the last dose. If you or your partner becomes pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this medication and for 1 week after the last dose. Consult your doctor before breastfeeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin, enoxaparin), live vaccines (such as flu vaccine inhaled through the nose, typhoid/polio vaccine taken by mouth), pentostatin, other drugs that weaken the immune system/increase the risk of infection (such as natalizumab, rituximab), salicylates/NSAIDs (such as aspirin, ibuprofen, naproxen).Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, and aspirin) that can increase your risk of bleeding. However, if your doctor has told you to take low-dose aspirin to prevent heart attack or stroke (usually 81-162 milligrams a day), you should keep taking the aspirin unless your doctor tells you not to. Ask your doctor or pharmacist for more details.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.
NOTES: Lab and/or medical tests (such as complete blood count) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised November 2024. Copyright(c) 2024 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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