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Severe birth defects or embryo-fetal death may occur if taken during pregnancy. Should never be used by pregnant women or females who could become pregnant. Approved for marketing only through a special restricted distribution program called the "THALOMID REMS program." May increase risk of venous thromboembolism in patients w/ multiple myeloma (MM), especially w/ standard chemotherapeutic agents including dexamethasone; observe for signs/symptoms of thromboembolism. Instruct patients to seek medical care if symptoms such as SOB, chest pain, or arm or leg swelling develop. Consider thromboprophylaxis based on assessment of individual's underlying risk factors.
Newly Diagnosed:200mg qd; administer in combination w/ dexamethasone 40mg PO on Days 1-4, 9-12, and 17-20, every 28 days
Acute Treatment of Cutaneous Manifestations:Initial: 100-300mg qd
Patients <50kg:Start at low end of dosing range
Patients w/ Severe Cutaneous Reaction or Who Previously Required Higher Doses to Control Reaction:May initiate at higher doses up to 400mg/day qhs or in divided doses w/ water, at least 1 hr after meals
Moderate-Severe Neuritis Associated w/ Severe Cutaneous Reaction:May initiate corticosteroids concomitantly w/ thalidomide; taper steroid usage and d/c when neuritis has ameliorated
Continue dosing w/ thalidomide until signs and symptoms of active reaction have subsided, usually at least 2 weeks; patients may then be tapered off medication in 50mg decrements every 2-4 weeks
Maint Therapy for Prevention/Suppression of Recurrence:Use the minimum dose necessary to control reaction; attempt tapering off medication every 3-6 months, in decrements of 50mg every 2-4 weeks
≥12 Years:Newly Diagnosed: 200mg qd; administer in combination w/ dexamethasone 40mg PO on Days 1-4, 9-12, and 17-20, every 28 days
≥12 Years:Acute Treatment of Cutaneous Manifestations:Initial: 100-300mg qd
Adverse ReactionsConsider dose reduction, delay, or discontinuation in patients who develop NCI CTC Grade 3 or 4 adverse reactions and/or based on clinical judgmentMM: Patients who develop reactions (eg, constipation, somnolence, peripheral neuropathy) may benefit by either temporarily discontinuing the drug or continuing at a lower dose; drug may be started at a lower dose or at the previous dose w/ the abatement of these adverse reactions
Take w/ water, preferably hs and at least 1 hr after evening meal.Do not open/crush caps.
Handling PrecautionsIf powder contacts the skin, wash immediately and thoroughly w/ soap and water.If powder contacts mucous membranes, flush thoroughly w/ water.
Cap: 50mg, 100mg, 150mg, 200mg
Pregnancy, hypersensitivity to thalidomide or its components.
Females of reproductive potential should avoid contact w/ caps. Healthcare providers or other caregivers should utilize appropriate precautions to prevent potential cutaneous exposure. Females of reproductive potential must avoid pregnancy and must commit either to completely abstain from heterosexual intercourse or to use 2 methods of reliable birth control (at least 1 highly effective method required even w/ history of infertility, unless due to hysterectomy) for at least 4 weeks before beginning therapy, during therapy, during dose interruptions, and for at least 4 weeks after completing therapy. Perform appropriate pregnancy tests prior to and during therapy. Male patients (including those w/ vasectomy) w/ female partners of reproductive potential must always use a latex/synthetic condom during any sexual contact during therapy and for up to 28 days after discontinuation of therapy. Male patients must not donate sperm. Patients must not donate blood during treatment and for 1 month following discontinuation. Ischemic heart disease, including MI, and stroke reported in patients w/ previously untreated MM. May impair physical/mental ability; dose reductions may be required. May cause irreversible peripheral neuropathy; d/c therapy if drug-induced neuropathy develops. May cause dizziness and orthostatic hypotension. Decreased WBC counts, including neutropenia, reported. Do not initiate if ANC is <750/mm3; reevaluate therapy and consider withholding thalomid. Thrombocytopenia, including Grade 3 or 4 occurrences reported; dose reduction, delay, or discontinuation may be required. May increase plasma HIV RNA levels in HIV-seropositive patients. Bradycardia reported; dose reduction or discontinuation may be required. May cause serious dermatologic reactions (eg, Stevens-Johnson syndrome [SJS], toxic epidermal necrolysis [TEN]); d/c if skin rash occurs and do not resume therapy if the rash is exfoliative, purpuric, or bullous or if SJS or TEN is suspected. Seizures, including grand mal convulsions, reported. Caution in patients at risk of tumor lysis syndrome. Consider risks of adverse effects in choosing contraceptive methods. Hypersensitivity reported; may necessitate interruption of therapy if a severe hypersensitivity reaction occurs. D/C if the reaction recurs when dosing is resumed. Not indicated as monotherapy for cutaneous manifestations of moderate/severe erythema nodosum leprosum (ENL) in the presence of moderate/severe neuritis.
MM: Fatigue, hypocalcemia, edema, constipation, sensory neuropathy, dyspnea, muscle weakness, leukopenia, neutropenia, rash/desquamation, confusion, anorexia, nausea, anxiety.ENL: Somnolence, rash, headache.
See Boxed Warning. Avoid w/ medications that may cause drowsiness (eg, opioids, antihistamines, antipsychotics, antianxiety agents, CNS depressants). Caution w/ drugs that may cause additive bradycardic effect (eg, calcium channel blockers, β-blockers, digoxin, lithium). Caution w/ drugs associated w/ peripheral neuropathy (eg, amiodarone, docetaxel, vincristine). Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements (eg, St. John's wort) w/ hormonal contraceptive agents may reduce effectiveness of the contraception up to 1 month after discontinuation of these concomitant therapies; females requiring treatment w/ 1 or more of these drugs must use two other effective or highly effective methods of contraception while taking thalidomide. Caution w/ erythropoietic agents or other agents that may increase the risk of thromboembolism (eg, estrogen-containing therapies) in patients w/ MM.
Pregnancy: Category X.Lactation: Not for use in nursing.
Immunomodulatory agent; not established. Possesses immunomodulatory, anti-inflammatory, and antiangiogenic properties. Immunologic effects may be caused by suppression of excessive TNF-α production and down-modulation of selected cell surface adhesion molecules involved in leukocyte migration. May suppress macrophage involvement in prostaglandin synthesis and modulation of interleukin-10 and -12 production by peripheral blood mononuclear cells. In MM, increased numbers of circulating natural killer cells and plasma levels of interleukin-2 and interferon-gamma are also seen. Angiogenesis inhibition may include the proliferation of endothelial cells.
Absorption: Slow. Administration of variable doses resulted in different parameters. Distribution: Plasma protein binding (55%, [+]-[R]-thalidomide and 66%, [-]-[S]-thalidomide). Metabolism: Hydrolysis. Elimination: Feces (<2%); urine (91.9%, <3.5% unchanged); T1/2=5.5-7.3 hrs.
Assess use in those capable of reproduction. Assess that patients are committed to either abstaining from heterosexual contact or willing to use a latex/synthetic condom for males or 2 forms of reliable contraception, including 1 highly effective method and 1 additional effective method for females, and beginning 4 weeks prior to treatment for females. Assess pregnancy status w/in 10-14 days and w/in 24 hrs prior to therapy. Assess for moderate to severe neuritis, history/risk factors for seizures, hypersensitivity to drug, nursing status, and possible drug interactions. Consider electrophysiological testing. Obtain baseline neutrophil counts.
Monitor for venous thromboembolism, ischemic heart disease, MI, stroke, drowsiness, somnolence, peripheral neuropathy, dizziness, orthostatic hypotension, neutropenia, hypersensitivity reactions, bradycardia, syncope, seizures, serious dermatological reactions, missed periods or abnormal menstrual bleeding, and other adverse reactions. Monitor for signs/symptoms of bleeding, especially if on concomitant medication that may increase the risk of bleeding. Perform pregnancy test weekly during 1st month, then repeat monthly (regular menstrual cycle) or every 2 weeks (irregular menstrual cycle). Monitor for use of reliable methods of birth control (2 methods for females) during therapy, during dose interruptions, and continuing for 4 weeks after completing therapy. Perform electrophysiologic testing every 6 months, and WBC w/ differential count periodically. In HIV patients, monitor viral load after 1st and 3rd months of therapy and every 3 months thereafter. Monitor patients at risk of tumor lysis syndrome. Examine for early signs of neuropathy at monthly intervals for the first 3 months of therapy.
Inform that drug is only available through a restricted distribution program and only from certified pharmacies; patients must sign a patient-prescriber agreement form and comply w/ the requirements. Inform that drug is contraindicated in pregnancy and can cause serious birth defects or embryo-fetal death; advise females of reproductive potential to avoid pregnancy during and for at least 4 weeks after therapy. Advise of the importance of monthly pregnancy tests and to use 2 different forms of contraception, including at least 1 highly effective form, simultaneously during therapy, during dose interruptions, and for 4 weeks after completing therapy. Instruct patients to immediately d/c and contact physician if they become pregnant, miss their menstrual period, experience unusual menstrual bleeding, or if they stop birth control. Advise males (including those w/ vasectomy) to use latex/synthetic condoms during any sexual contact during and up to 28 days after discontinuation of therapy; advise also not to donate sperm during therapy. Instruct not to donate blood during therapy and for 1 month following discontinuation. Inform of the potential risk of venous thromboembolism (eg, deep vein thrombosis, pulmonary embolism), ischemic heart disease (eg, MI), and stroke, and of need for prophylactic treatment. Inform of the risk of dizziness and orthostatic hypotension w/ therapy; advise to sit upright for a few minutes prior to standing up from a recumbent position. Inform of other risks associated w/ therapy.
20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Store in blister packs until ingestion. Protect from light.