Dosing & Uses
Dosage Forms & Strengths
capsule
- 50mg
- 100mg
- 150mg
- 200mg
Erythema Nodosum Leprosum (ENL)
Indicated for acute treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum (ENL); also indicated as maintenance therapy for prevention and suppression of cutaneous recurrence
Also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
Note: Not indicated as monotherapy for ENL in the presence of moderate-to-severe neuritis
Initial: 100-300 mg PO qDay with water, preferably at bedtime at least 1 hr after evening meal
Weight <50 kg: Initiate at low end of dose range
Severe cutaneous ENL or patient previously requiring higher doses: May start at 400 mg/day (qHS or in divided doses at least 1 hr pc)
Consider concomitant use of corticosteroids in patients with moderate-to-severe neuritis associated with a severe ENL reaction; taper steroid and discontinued when neuritis has ameliorated
Dose tapering
- Continue thalidomide until active symptoms have subsided, usually at least 2 weeks, then titrate downward by 50-mg decrements q2-4 weeks
- Patients who have a documented history of requiring prolonged maintenance treatment to prevent cutaneous ENL recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; attempt tapering off medication should q3-6 months by 50-mg decrements q2-4 weeks
Multiple Myeloma
Indicated in combination with dexamethasone for newly diagnosed multiple myeloma (MM)
200 mg PO qHS in 28-day cycles PLUS
Dexamethasone 40 mg PO on Days 1-4, 9-12, and 17-20 of each 28-day cycle
Dosage Modifications
Interrupt Dosing: Constipation, somnolence, or peripheral neuropathy; consider dose reduction upon treatment resumption
Grade 3-4 adverse effects: Consider dose reduction, delay, or discontinuation
Permanently discontinue: Angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, any other severe dermatologic reactions, or other reactions based on clinical judgment
Dosing Considerations
Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing
Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy
Must only be administered in compliance with all of the terms outlined in the Thalomid REMS program
May only be prescribed by prescribers certified and may only be dispensed by pharmacists certified with the Thalomid REMS program
Orphan Designations
Graft versus host disease (GVHD)
- Orphan designation for prevention and treatment of GVHD
- Orphan sponsor: Andrulis Research Corporation; 11800 Baltimore Avenue, Suite 113; Beltsville, MD 20705
Mycobacterial infection
- Orphan designation for treatment of the clinical manifestations of mycobacterial infection caused by Mycobacterium tuberculosis and non-tuberculous mycobacteria
- Orphan sponsor: Celgene Corporation; PO Box 4914; 7 Powder Horn Drive; Warren, NJ 07059
Recurrent aphthous ulcers
- Orphan designation for treatment and prevention of recurrent aphthous ulcers in severely, terminally immunocompromised patients
- Orphan sponsor: Andrulis Research Corporation; 11800 Baltimore Avenue, Suite 113; Beltsville, MD 20705
Severe recurrent aphthous stomatitis
- Orphan designation for treatment of severe recurrent aphthous stomatitis in severely, terminally immunocompromised patients
- Orphan sponsor: Celgene Corporation; PO Box 4914; 7 Powder Horn Drive; Warren, NJ 07059
Primary brain malignancies
- Orphan designation for treatment of primary brain malignancies
- Orphan sponsor: Celgene Corporation; 7 Powder Horn Dr; Warren, NJ 07059
HIV-associated wasting syndrome
- Indicated for treatment of HIV-associated wasting syndrome
- Orphan sponsor: Celgene Corporation; PO Box 4914; 7 Powder Horn Drive; Warren, NJ 07059
Crohn disease
- Orphan designation for treatment of Crohn disease
- Orphan sponsor: Celgene Corporation; 7 Powder Horn Dr; Warren, NJ 07059
Kaposi sarcoma
- Orphan designation for treatment of Kaposi sarcoma
- Orphan sponsor: Celgene Corporation; 7 Powder Horn Dr; Warren, NJ 07059
Myelodysplastic syndrome
- Orphan designation for treatment of myelodysplastic syndrome
- Orphan sponsor: Celgene Corporation; 86 Morris Avenue; Summit, NJ 07901
Hematopoietic stem cell transplantation
- Orphan designation for conditioning treatment prior to hematopoietic stem cell transplantation
- Orphan sponsor: Adienne Srl; 24128 Bergamo; 64/B Broseta Street; Bergamo; ITALY
Telangiectasia
- Orphan designation for hereditary hemorrhagic telangiectasia
- Orphan sponsor: PlumeStars s.r.l.; Via Lago Scuro11 43124; Parma; Italy
Dosage Forms & Strengths
capsule
- 50mg
- 100mg
- 150mg
- 200mg
Erythema Nodosum Leprosum (ENL)
Indicated for acute treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum (ENL); also indicated as maintenance therapy for prevention and suppression of cutaneous recurrence
Also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence
Note: Not indicated as monotherapy for ENL in the presence of moderate-to-severe neuritis
<12 years: Safety and efficacy not established
≥12 years
- Initial: 100-300 mg PO qDay with water, preferably at bedtime at least 1 hr after evening meal
- Weight <50 kg: Initiate at low end of dose range
- Severe cutaneous ENL or patient previously requiring higher doses: May start at 400 mg/day (qHS or in divided doses at least 1 hr pc)
- Consider concomitant use of corticosteroids in patients with moderate-to-severe neuritis associated with a severe ENL reaction; taper steroid and discontinued when neuritis has ameliorated
Dose tapering
- Continue thalidomide until active symptoms have subsided, usually at least 2 weeks, then titrate downward by 50-mg decrements q2-4 weeks
- Patients who have a documented history of requiring prolonged maintenance treatment to prevent cutaneous ENL recurrence or who flare during tapering should be maintained on the minimum dose necessary to control the reaction; attempt tapering off medication should q3-6 months by 50-mg decrements q2-4 weeks
Dosage Modifications
Interrupt Dosing: Constipation, somnolence, or peripheral neuropathy; consider dose reduction upon treatment resumption
Grade 3-4 adverse effects: Consider dose reduction, delay, or discontinuation
Permanently discontinue: Angioedema, anaphylaxis, Grade 4 rash, skin exfoliation, bullae, any other severe dermatologic reactions, or other reactions based on clinical judgment
Dosing Considerations
Drug prescribing to females of reproductive potential is contingent upon initial and continued negative results of pregnancy testing
Females of reproductive potential must avoid pregnancy for at least 4 weeks before beginning therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy
Must only be administered in compliance with all of the terms outlined in the Thalomid REMS program
May only be prescribed by prescribers certified and may only be dispensed by pharmacists certified with the Thalomid REMS program
Interactions
Interaction Checker
No Results
Contraindicated
Serious
Significant - Monitor Closely
Minor
Contraindicated (41)
- acrivastine
acrivastine and thalidomide both increase sedation. Contraindicated.
- amisulpride
amisulpride and thalidomide both increase sedation. Contraindicated.
- anakinra
anakinra increases toxicity of thalidomide by Other (see comment). Contraindicated. Comment: Avoid concomitant use due to increased risk of infection.
- asenapine
asenapine and thalidomide both increase sedation. Contraindicated.
- asenapine transdermal
asenapine transdermal and thalidomide both increase sedation. Contraindicated.
- avapritinib
avapritinib and thalidomide both increase sedation. Contraindicated.
- benzhydrocodone/acetaminophen
benzhydrocodone/acetaminophen and thalidomide both increase sedation. Contraindicated.
- brexpiprazole
brexpiprazole and thalidomide both increase sedation. Contraindicated.
- brimonidine
brimonidine and thalidomide both increase sedation. Contraindicated.
- brivaracetam
brivaracetam and thalidomide both increase sedation. Contraindicated.
- buprenorphine subdermal implant
buprenorphine subdermal implant and thalidomide both increase sedation. Contraindicated.
- buprenorphine transdermal
buprenorphine transdermal and thalidomide both increase sedation. Contraindicated.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and thalidomide both increase sedation. Contraindicated.
- cariprazine
cariprazine and thalidomide both increase sedation. Contraindicated.
- clobazam
clobazam and thalidomide both increase sedation. Contraindicated.
- clonidine
clonidine and thalidomide both increase sedation. Contraindicated.
- desloratadine
desloratadine and thalidomide both increase sedation. Contraindicated.
- dexbrompheniramine
dexbrompheniramine and thalidomide both increase sedation. Contraindicated.
- diazepam buccal
diazepam buccal and thalidomide both increase sedation. Contraindicated.
- diazepam intranasal
diazepam intranasal and thalidomide both increase sedation. Contraindicated.
- eszopiclone
eszopiclone and thalidomide both increase sedation. Contraindicated.
- fentanyl
fentanyl and thalidomide both increase sedation. Contraindicated.
- fentanyl intranasal
fentanyl intranasal and thalidomide both increase sedation. Contraindicated.
- fentanyl iontophoretic transdermal system
fentanyl iontophoretic transdermal system and thalidomide both increase sedation. Contraindicated.
- fentanyl transdermal
fentanyl transdermal and thalidomide both increase sedation. Contraindicated.
- fentanyl transmucosal
fentanyl transmucosal and thalidomide both increase sedation. Contraindicated.
- levetiracetam
levetiracetam and thalidomide both increase sedation. Contraindicated.
- levocetirizine
levocetirizine and thalidomide both increase sedation. Contraindicated.
- loratadine
loratadine and thalidomide both increase sedation. Contraindicated.
- lurasidone
lurasidone and thalidomide both increase sedation. Contraindicated.
- meclizine
meclizine and thalidomide both increase sedation. Contraindicated.
- methohexital
methohexital and thalidomide both increase sedation. Contraindicated.
- methsuximide
methsuximide and thalidomide both increase sedation. Contraindicated.
- molindone
molindone and thalidomide both increase sedation. Contraindicated.
- nitrous oxide
nitrous oxide and thalidomide both increase sedation. Contraindicated.
- oliceridine
oliceridine and thalidomide both increase sedation. Contraindicated.
- opicapone
opicapone and thalidomide both increase sedation. Contraindicated.
- remifentanil
remifentanil and thalidomide both increase sedation. Contraindicated.
- tasimelteon
tasimelteon and thalidomide both increase sedation. Contraindicated.
- tetrabenazine
tetrabenazine and thalidomide both increase sedation. Contraindicated.
- tolcapone
tolcapone and thalidomide both increase sedation. Contraindicated.
Serious (15)
- clonidine
clonidine, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Enhanced CNS depressant effects.
- deferiprone
deferiprone, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Avoid use of deferiprone with other drugs known to be associated with neutropenia or agranulocytosis; if an alternative is not possible, monitor absolute neutrophil count more frequently.
- landiolol
landiolol, thalidomide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of beta blockers with other negative inotropes or chronotropes may augment myocardial contractility depression and increase risk of bradycardia or heart block.
- lumateperone
lumateperone and thalidomide both increase sedation. Avoid or Use Alternate Drug.
- metoclopramide intranasal
thalidomide, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.
- nivolumab
thalidomide increases toxicity of nivolumab by Other (see comment). Avoid or Use Alternate Drug. Comment: Immunosuppression diminishes therapeutic effect of nivolumab; combination also increases mortality in patients with multiple myeloma when thalidomide and dexamethasone added to therapy.
- olopatadine intranasal
thalidomide and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- palifermin
palifermin increases toxicity of thalidomide by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, 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.
- ponesimod
ponesimod, thalidomide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.
- ropeginterferon alfa 2b
ropeginterferon alfa 2b, thalidomide. 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.
- selinexor
selinexor, thalidomide. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.
- stiripentol
stiripentol, thalidomide. Either increases effects of the other by sedation. Avoid or Use Alternate Drug. Concurrent use of medications with CNS depressant effects together with thalidomide should be avoided due to the risk for additive sedative effects.
- tocilizumab
tocilizumab, thalidomide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive immunosuppression; risk of serious infection.
- vedolizumab
vedolizumab and thalidomide both increase immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid coadministration of vedolizumab with TNF blockers because of the potential for increased risk of infections
- zuranolone
thalidomide, zuranolone. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Coadministration of zuranolone with other CNS depressants may increase impairment of psychomotor performance or CNS depressant effects. If unavoidable, consider dose reduction. .
Monitor Closely (27)
- amobarbital
thalidomide increases effects of amobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- brexanolone
brexanolone, thalidomide. Either increases toxicity of the other by sedation. Use Caution/Monitor.
- butabarbital
thalidomide increases effects of butabarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- butalbital
thalidomide increases effects of butalbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- cenobamate
cenobamate, thalidomide. Either increases effects of the other by sedation. Use Caution/Monitor.
- chlorpromazine
thalidomide increases effects of chlorpromazine by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- cholera vaccine
thalidomide 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.
- daridorexant
thalidomide and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.
- dichlorphenamide
dichlorphenamide and thalidomide both decrease serum potassium. Use Caution/Monitor.
- difelikefalin
difelikefalin and thalidomide both increase sedation. Use Caution/Monitor.
- esketamine intranasal
esketamine intranasal, thalidomide. Either increases toxicity of the other by sedation. Modify Therapy/Monitor Closely.
- ethanol
thalidomide increases effects of ethanol by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- fingolimod
thalidomide 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. .
- ganaxolone
thalidomide and ganaxolone both increase sedation. Use Caution/Monitor.
- lasmiditan
lasmiditan, thalidomide. Either increases effects of the other by sedation. Use Caution/Monitor. Coadministration of lasmiditan and other CNS depressant drugs, including alcohol have not been evaluated in clinical studies. Lasmiditan may cause sedation, as well as other cognitive and/or neuropsychiatric adverse reactions.
- lemborexant
lemborexant will increase the level or effect of thalidomide by sedation. Modify Therapy/Monitor Closely. Dosage adjustment may be necessary if lemborexant is coadministered with other CNS depressants because of potentially additive effects.
- lurasidone
lurasidone, thalidomide. Either increases toxicity of the other by Other (see comment). Use Caution/Monitor. Comment: Potential for increased CNS depressant effects when used concurrently; monitor for increased adverse effects and toxicity.
- mechlorethamine
mechlorethamine, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Use Caution/Monitor. Coadministration with mechlorethamine may increase the risk of immunosuppression and myelosuppression.
- midazolam intranasal
midazolam intranasal, thalidomide. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase the risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.
- ofatumumab SC
ofatumumab SC, thalidomide. 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.
- pentobarbital
thalidomide increases effects of pentobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- phenobarbital
thalidomide increases effects of phenobarbital by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- primidone
thalidomide increases effects of primidone by unspecified interaction mechanism. Use Caution/Monitor. Increased sedative effects.
- siponimod
siponimod and thalidomide 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
thalidomide decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.
- trastuzumab
trastuzumab, thalidomide. 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, thalidomide. 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.
Minor (4)
- benazepril
thalidomide, benazepril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.
- captopril
thalidomide, captopril. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. May increase risk of hypotension.
- food
food decreases levels of thalidomide by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Esp. high fat foods.
- shark cartilage
thalidomide, shark cartilage. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Enhanced anti angiogenesis (theoretical interaction).
Adverse Effects
>10% (MM All Grades)
Fatigue (21-79%)
Hypocalcemia (72%)
Edema (13-56%)
Constipation (50-55%)
Neuropathy-sensory (54%)
Dyspnea (42%)
Muscle weakness (40%)
Leukocytes decreased (35%)
Peripheral edema (34%)
Neutrophils decreased (31%)
Rash/desquamation (30%)
Confusion (28%)
Anorexia (28%)
Nausea (13-28%)
Anxiety/agitation (26%)
Tremor (26%)
Fever (24%)
Asthenia (24%)
Weight loss (23%)
Weight gain (22%)
Thrombosis/embolism (22%)
Neuropathy-motor (22%)
Dry skin (21%)
Dizziness/lightheadedness (20-23%)
Myalgia (17%)
Depressed level of consciousness (16%)
Pneumonia (15%)
Hyperglycemia (15%)
Bilirubin (14%)
Arthralgia (13%)
Deep vein thrombosis (13%)
Dry mouth (12%)
Paresthesia (12%)
Anxiety (12%)
Dyspepsia (11%)
>10% (ENL)
Somnolence (36-38%)
Rash (21-25%)
Leukopenia (17-25%)
Fever (17-22%)
Asthenia (6-22%)
Headache (13-19%)
Diarrhea (11-19%)
Dizziness (4-19%)
Maculopapular rash (4-19%)
Paresthesia (6-16%)
Sweating (13%)
Anemia (6-13%)
Lymphadenopathy (6-13%)
Nausea (4-13%)
SGOT increased (3-13%)
Hematuria (11%)
Postmarketing Reports
Blood and lymphatic: Decreased white blood cell counts including febrile neutropenia, changes in prothrombin time, pancytopenia, chronic myelogenous leukemia, nodular sclerosing Hodgkin disease, erythroleukemia, lymphedema, and lymphopenia
Body as a whole: Hangover effect
Cardiovascular System: Sick sinus syndrome, EKG abnormalities, pulmonary hypertension
Digestive system: Intestinal perforation, gastrointestinal perforations, bile duct obstruction, stomach ulcer, aphthous, stomatitis
Ear and labyrinthine disorders: Hearing impairment
Immune system disorders: Hypersensitivity including anaphylaxis, solid organ transplant rejection
Infections and infestations: Severe infections (eg, fatal sepsis including septic shock) and viral infections (including varicella zoster virus, cytomegalovirus, and hepatitis B virus reactivation), progressive and multifocal leukoencephalopathy
Metabolic and endocrine: Electrolyte imbalance including hypercalcemia, hyponatremia and hypomagnesemia, hypothyroidism, increased alkaline phosphatase, tumor lysis syndrome, myxedema
Nervous system: Changes in mental status or mood including suicide attempts, disturbances in consciousness including lethargy, loss of consciousness or stupor, seizures including grand mal convulsions and status epilepticus, Parkinson disease, stroke, carpal tunnel, Raynaud syndrome, migraine, foot drop
Renal and urinary disorders: Renal failure, acute renal failure, oliguria, enuresis
Reproductive system and breast disorders: amenorrhea, sexual dysfunction, galactorrhea, gynecomastia, metrorrhagia
Respiratory system: Pleural effusion, interstitial lung disease
Skin and appendages: Erythema multiforme, erythema nodosum, toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), purpura, petechiae
Special senses: Diplopia, nystagmus
Warnings
Black Box Warnings
Embryo-fetal toxicity
- If taken during pregnancy, thalidomide can cause severe birth defects or embryo-fetal death
- Never prescribe for females who are pregnant or who could be pregnant while taking the drug
- Even a single dose (1 capsule, regardless of strength) taken by a pregnant woman during her pregnancy can cause severe birth defects
- Pregnancy must be excluded before initiating treatment
- Prevent pregnancy thereafter by the use of 2 reliable contraceptive methods
- Prescribers must be certified with the THALOMID REMS program by enrolling and complying with the REMS requirements
Venous thromboembolic events
- Significantly increases risk of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients treated for multiple myeloma; this risk increases significantly when used with standard chemotherapeutic agents, including dexamethasone
- In one controlled trial, the rate of venous thromboembolic events was 22.5% in patients receiving thalidomide in combination with dexamethasone compared with 4.9% in patients receiving dexamethasone alone (P = 0.002)
- Observe for signs and symptoms of thromboembolism and instruct patients to seek medical care if they develop shortness of breath, chest pain, or arm or leg swelling
- Preliminary data suggest that patients who are appropriate candidates may benefit from concurrent prophylactic anticoagulation or aspirin treatment
Contraindications
Hypersensitivity
Pregnancy; highly teratogenic (even a single dose)
Cautions
Powerful human teratogen that induces a high frequency of severe and life-threatening birth defects, even after a single dose; mortality at or shortly after birth reported in ~40% of infants; when there is no satisfactory alternant treatment, females of reproductive potential may be treated with thalidomide provided adequate precautions are taken to avoid pregnancy; only available through the Thalomid REMS program (see Black Box Warnings, Contraindications, and Pregnancy)
Do not donate blood during treatment and for 4 weeks following discontinuation of the drug because the blood might be given to a pregnant female patient whose fetus must not be exposed thalidomide
Increased risk of venous thromboembolism reported in patients with multiple myeloma (MM) treatment; the presence of underlying malignancy, and/or use of an estrogen-containing contraceptive can each increase risk of thromboembolism; it is not known if these risks of thromboembolism are additive; however, should be taken into consideration when choosing contraceptive methods (see Black Box Warnings)
Ischemic heart disease (including myocardial infarction) and stroke observed
Drowsiness and somnolence may occur; instruct patients to avoid situations where drowsiness may be a problem and not to take other medications that may cause drowsiness
Peripheral neuropathy reported; examine patients at monthly intervals for the first 3 months of therapy and periodically thereafter; consider electrophysiological testing, consisting of measurement of sensory nerve action potential (SNAP) amplitudes at baseline and thereafter every 6 months in an effort to detect asymptomatic neuropathy; usually, treatment with this drug should only be reinitiated if neuropathy returns to baseline status
Dizziness and orthostatic hypotension may occur; advise patients to sit upright for a few minutes prior to standing up from a recumbent position
Thrombocytopenia, including Grade 3 or 4 occurrences, reported in association with the clinical use of thalidomide; monitor blood counts, including platelet counts; dose reduction, delay, or discontinuation may be required; monitor for signs and symptoms of bleeding including petechiae, epistaxis, and gastrointestinal bleeding, especially if concomitant medication may increase the risk of bleeding
May increased HIV viral load when used in HIV-seropositive patients; clinical significance unknown, measure viral load after the first and third months of treatment and every 3 months thereafter
Monitor for bradycardia and possible syncope; dose reduction or discontinuation may be required
Monitor patients with a history of seizures or at risk for the development of seizures closely for clinical changes that could precipitate acute seizure activity
Tumor lysis syndrome may occur; monitor patients at risk (eg, those with high tumor burden prior to treatment) and take appropriate precautions
Hypersensitivity reported, including angioedema and anaphylaxis; signs and symptoms include the occurrence of erythematous macular rash, possibly associated with fever, tachycardia, and hypotension, and if severe, may necessitate therapy interruption; if the reaction recurs when dosing is resumed, discontinue thalidomide; do not resume treatment after angioedema and anaphylaxis
Increased mortality was observed in 2 randomized clinical trials in patients with multiple myeloma when pembrolizumab was added to a thalidomide analog and dexamethasone; treatment with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analog plus dexamethasone is not recommended outside of controlled clinical trials
Neutropenia
- Decreased white blood cell counts, including neutropenia, reported with therapy; treatment should not be initiated with an absolute neutrophil count (ANC) of <750/mm3; white blood cell count and differential should be monitored on an ongoing basis, especially in patients who maybe more prone to neutropenia, such as patients who are HIV-seropositive
- If ANC decreases to below 750/mm3 while on treatment, the patient’s medication regimen should be re-evaluated and, if neutropenia persists, consideration should be given to withholding therapy if clinically appropriate
Severe cutaneous reactions
- Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) reported
- DRESS may present with cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis; which can be fatal; consider interruption or discontinuation or therapy for Grade 2-3 skin rash
- Discontinue therapy for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS; do not resume therapy
Drug interaction overview
- Avoid coadministration with other drugs that may cause additive sedation (eg, opioids, antihistamines, antipsychotics, antianxiety agents, CNS depressants)
- Additive effects may occur if coadministered with drugs that cause peripheral neuropathy (eg, bortezomib, amiodarone, cisplatin, docetaxel, paclitaxel, vincristine, disulfiram, phenytoin, metronidazole, alcohol); use cautiously
- Hormonal contraceptives increase risk of thromboembolism; unknown if coadministration further increases this risk
- Caution if erythropoietic agents or other agents that increase risk of thromboembolism (eg, estrogen containing therapies) are coadministered in patients receiving thalidomide with dexamethasone for multiple myeloma
-
Drugs that interfere with hormonal contraception
- Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements (eg, St. John’s Wort) with hormonal contraceptive agents may reduce the effectiveness of the contraception up to 1 month after discontinuation of these concomitant therapies
- Females requiring treatment with 1 or more of these drugs must use 2 OTHER effective or highly effective methods of contraception while taking thalidomide
-
Bradycardia
- Drugs which slow cardiac conduction may cause an additive bradycardic effect if coadministered with thalidomide and should be used with caution
- Cardiovascular medications which may cause bradycardia include calcium channel blockers, beta blockers, alpha/beta-adrenergic blockers, and digoxin
- Noncardiac drugs that may cause bradycardia include H2 blockers, lithium, TCAs, and neuromuscular blockers
Pregnancy & Lactation
Pregnancy
Potent teratogen; contraindicated during pregnancy (see Black Box Warnings; Contraindications, Cautions)
Based on the mechanism of action, human and animal data, thalidomide can cause embryo-fetal harm when administered to pregnant female
It is a powerful human teratogen, inducing a high frequency of severe and life-threatening birth defects, even after a single dose
Mortality at or shortly after birth reported in ~40% of infants
If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to a fetus
If pregnancy occurs during treatment, discontinue the drug immediately
Contraception
Females
- Females must commit either to abstain continuously from heterosexual sexual intercourse or to use 2 methods of reliable birth control, beginning 4 weeks before initiating treatment, during therapy, during dose interruptions, and continuing for 4 weeks following therapy discontinuation
- 2 negative pregnancy tests must be obtained before initiating; the first test should be performed within 10-14 days and the second test within 24 hr before prescribing therapy and then weekly during the first month, then monthly thereafter in females with regular menstrual cycles or q2week in females with irregular menstrual cycles
Males
- Thalidomide is present in the semen of patients; therefore, males must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking thalidomide and for up to 4 weeks after discontinuing, even if they have undergone a successful vasectomy
- Male patients taking thalidomide must not donate sperm
Lactation
There is no information regarding presence of thalidomide in human milk; effects of thalidomide on breastfed infant, or effects of thalidomide on milk production
Because many drugs are excreted in human milk and because of potential for adverse reactions in breastfed infants from thalidomide advise women not to breastfeed during therapy
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
Mechanism of Action
Suppresses tumor necrosis factor alpha; down-modulates cell surface adhesion molecules involved in leukocyte migration
Anticancer activity may be due to inhibition of angiogenesis
Pharmacokinetics
Bioavailability: 90%
Protein bound: 55-66%
Peak plasma time: 3-6 hr
Half-life: 5-7 hr
Peak plasma concentration: 1.15-3.2 mcg/mL
Vd: 122 L
Metabolism: Liver
Clearance: 1.15 mL/min
Excretion: Urine
Administration
Oral Administration
Take with water at bedtime, at least 1 hr after evening meal
Consider dose reduction, delay, or discontinuation in patients who develop NCI CTC (National Cancer Institute Common Toxicity Criteria) Grade 3 or 4 adverse reactions and/or based on clinical judgment
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Thalomid oral - | 50 mg capsule |  | |
| Thalomid oral - | 200 mg capsule |  | |
| Thalomid oral - | 100 mg capsule |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
thalidomide oral
THALIDOMIDE - ORAL
(tha-LID-oh-mide)
COMMON BRAND NAME(S): Thalomid
WARNING: Women who are pregnant must not use thalidomide. Women must avoid becoming pregnant while taking this medication. Even a single dose of thalidomide has caused severe (often fatal) birth defects when used during pregnancy. You must have 2 negative pregnancy tests before you start treatment with thalidomide (within 10 to 14 days before and 24 hours before starting), repeating the test at least monthly. Do not start or continue thalidomide treatment unless you have a negative pregnancy test result.Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 1 month before starting thalidomide, during use, and for 1 month after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor right away. (See also Precautions section.)Because thalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Keep using condoms and other birth control as directed until 1 month after thalidomide treatment has been stopped.To receive thalidomide in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.When used to treat a certain type of cancer (multiple myeloma), thalidomide can increase the risk of serious problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you develop shortness of breath/rapid breathing, chest/jaw/left arm pain, weakness on one side of the body, trouble speaking, sudden vision changes, unusual sweating, confusion, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, or sudden/severe headaches. While you are taking thalidomide, your doctor may also direct you to take aspirin or other "blood thinners" (such as warfarin) to lessen the risk of these types of blood clots. Talk to your doctor for more information, and tell him/her if you have diabetes, high blood pressure or high cholesterol, kidney problems, or if you smoke. (See also Side Effects section.)
USES: This medication is used to treat or prevent certain skin conditions related to Hansen's disease, once known as leprosy (erythema nodosum leprosum). Thalidomide is also used to treat a certain type of cancer (multiple myeloma). It works in Hansen's disease by reducing swelling and redness (inflammation). It also reduces the formation of blood vessels that feed tumors.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using thalidomide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth as directed by your doctor, usually once daily at bedtime at least 1 hour after the evening meal. Swallow this medication whole with water.Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than prescribed. Your condition will not improve any faster, and the risk of serious side effects may be increased.Keep the capsules in their blister pack until ready to use. Do not open or break the capsules, or handle them any more than needed. If any of the powder from the capsule gets on your skin, wash the area with soap and water.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules. All people should wash their hands thoroughly after handling this drug.This medication passes into body fluids (such as urine). Avoid contact with body fluids from people taking this drug. Wear protective clothing (such as gloves) when handling these body fluids (such as during cleanup). If contact occurs, wash skin with soap and water.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. If you are taking this medication for Hansen's disease, your skin condition may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.Tell your doctor if your condition does not get better or if it gets worse after 2 weeks.
SIDE EFFECTS: See also Warning section.Drowsiness, dizziness, lightheadedness, constipation, weakness, and dry skin may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Thalidomide may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment has stopped. Tell your doctor right away if you develop any of the following symptoms: numbness/tingling/pain/burning in the feet or hands, muscle weakness/cramps, feeling of tightness in the feet.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, anxiety), shaking (tremor), shortness of breath, arm/leg swelling, fast/slow heartbeat, easy bruising/bleeding, black/bloody stools, vomit that contains blood or looks like coffee grounds.People with multiple myeloma who are treated with this medication may rarely get other cancers (such as acute leukemia). Consult your doctor for more details.Get medical help right away if you have any very serious side effects, including: seizures.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: fever, swollen lymph nodes, 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 taking thalidomide, 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: certain blood disorders (low platelet/white blood cell count), numbness/tingling of arms/legs, seizures.Caution is advised when using this drug in people with HIV because they may be more sensitive to the effects of the drug. While thalidomide is used to treat muscle wasting and other HIV-related conditions, the drug might affect the amount of HIV in your system (viral load). The manufacturer recommends having HIV tests from time to time.This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from broken capsules.Thalidomide must not be used during pregnancy due to the risk of severe birth defects and other serious, sometimes fatal harm to an unborn baby. If you are female and become pregnant or think you may be pregnant, if your period is late or you have unusual menstrual bleeding, or if you stop using 2 forms of birth control, stop taking thalidomide and tell your doctor right away. If you are male and have had unprotected sex with a woman who can become pregnant, or if you think your sexual partner may be pregnant, tell both of your doctors right away. (See also Warning section.)It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding is not recommended while using this drug. 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.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: alcohol, marijuana (cannabis), certain antihistamines (such as diphenhydramine), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, opioid pain relievers (such as codeine), psychiatric medicines (such as chlorpromazine, risperidone, amitriptyline, trazodone).Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.It is very important for women to use 2 forms of effective birth control while taking this medication. Some drugs may cause hormonal birth control (such as pills, patch, ring) to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), ritonavir, St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine), among others.Tell your doctor when you start any new drug, and discuss if you should use reliable backup birth control while using the new drug and for 1 month after stopping the new drug.
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. Symptoms of overdose may include: prolonged sleep.
NOTES: Do not share this medication with others. Do not donate blood, organs, eggs, or sperm while taking thalidomide.Lab and/or medical tests (such as pregnancy tests, white blood cell/platelet count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is more than 12 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Keep capsules in the original blister pack until ready to use. Do not store in the bathroom. 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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