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  • Thalomid
    (Thalidomide) - Celgene

    BOXED WARNING

    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 under a special restricted distribution program called the "THALOMID REMS program." May increase risk of venous thromboembolism in patients with multiple myeloma, especially with 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.

    THERAPEUTIC CLASS

    Immunomodulatory agent

    DEA CLASS

    RX

    INDICATIONS

    Treatment of newly diagnosed multiple myeloma in combination with dexamethasone. Acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). Maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence.

    ADULT DOSAGE

    Adults: Take with water, preferably at hs, and at least 1 hr after pm meal. Multiple Myeloma: 200mg qd. Give with dexamethasone 40mg PO on Days 1-4, 9-12, and 17-20, every 28 days. Temporarily d/c therapy or continue at a lower dose if constipation, somnolence, or peripheral neuropathy occurs; with abatement of these reactions, may start therapy at a lower dose or at the previous dose based on clinical judgment. ENL: Acute: Initial: 100-300mg qd. <50kg: Start at lower end of dosing range. Severe/Patients Who Previously Required Higher Doses to Control Reaction: Initial: Higher doses up to 400mg/day hs or in divided doses. May use corticosteroids in moderate to severe neuritis with severe ENL; taper and d/c steroid when neuritis is ameliorated. Usual Duration: At least 2 weeks until signs/symptoms have subsided. Taper dose in 50mg decrements every 2-4 weeks. Maint Therapy for Prevention/Suppression of ENL Recurrence: Use minimum dose to control reaction. Attempt tapering off therapy every 3-6 months, in decrements of 50mg every 2-4 weeks.

    PEDIATRIC DOSAGE

    Pediatrics: ≥12 Yrs: Take with water, preferably at hs, and at least 1 hr after pm meal. Multiple Myeloma: 200mg qd. Give with dexamethasone 40mg PO on Days 1-4, 9-12, and 17-20, every 28 days. Temporarily d/c therapy or continue at a lower dose if constipation, somnolence, or peripheral neuropathy occurs; with abatement of these reactions, may start therapy at a lower dose or at the previous dose based on clinical judgment. ENL: Acute: Initial: 100-300mg qd. <50kg: Start at lower end of dosing range. Severe/Patients Who Previously Required Higher Doses to Control Reaction: Initial: Higher doses up to 400mg/day hs or in divided doses. May use corticosteroids in moderate to severe neuritis with severe ENL; taper and d/c steroid when neuritis is ameliorated. Usual Duration: At least 2 weeks until signs/symptoms have subsided. Taper dose in 50mg decrements every 2-4 weeks. Maint Therapy for Prevention/Suppression of ENL Recurrence: Use minimum dose to control reaction. Attempt tapering off therapy every 3-6 months, in decrements of 50mg every 2-4 weeks.

    HOW SUPPLIED

    Cap: 50mg, 100mg, 150mg, 200mg

    CONTRAINDICATIONS

    Pregnancy.

    WARNINGS/PRECAUTIONS

    Females of reproductive potential should avoid contact with 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 required even with 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 with vasectomy) with 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. 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 absolute neutrophil count is <750/mm3. If these occur during therapy, consider discontinuation if clinically appropriate. 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; d/c if severe reactions develop. Not indicated as monotherapy for cutaneous manifestations of moderate/severe ENL in the presence of moderate/severe neuritis.

    ADVERSE REACTIONS

    Drowsiness/somnolence, peripheral neuropathy, dizziness, venous thromboembolism, neutropenia, rash, constipation, hypocalcemia, dyspnea, edema, anorexia, fatigue, tremor, nausea.

    DRUG INTERACTIONS

    See Boxed Warning. Avoid with medications that may cause drowsiness (eg, opioids, antihistamines, antipsychotics, antianxiety agents, CNS depressants). Caution with drugs that may cause additive bradycardic effect (eg, calcium channel blockers, β-blockers, digoxin, lithium). Caution with drugs associated with peripheral neuropathy (eg, amiodarone, docetaxel, vincristine). Concomitant use of HIV-protease inhibitors, griseofulvin, modafinil, penicillins, rifampin, rifabutin, phenytoin, carbamazepine, or certain herbal supplements such as St. John's wort with hormonal contraceptive agents may reduce effectiveness of the contraception up to 1 month after discontinuation of these concomitant therapies.

    PREGNANCY

    Category X, not for use in nursing.

    MECHANISM OF ACTION

    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 multiple myeloma, increased numbers of circulating natural killer cells and plasma levels of interleukin-2 and interferon-gamma are also seen. Angiogenesis inhibition may be due to proliferation of endothelial cells.

    PHARMACOKINETICS

    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%); T1/2=5.5-7.3 hrs.

    ASSESSMENT

    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, beginning 4 weeks prior to treatment. Assess pregnancy status within 10-14 days and within 24 hrs prior to therapy. Assess for moderate to severe neuritis, history/risk factors for seizures, drug hypersensitivity, nursing status, and possible drug interactions. Consider electrophysiological testing. Obtain baseline neutrophil counts.

    MONITORING

    Monitor for venous thromboembolism, drowsiness, somnolence, peripheral neuropathy, dizziness, orthostatic hypotension, neutropenia, hypersensitivity reactions, bradycardia, syncope, seizures, serious dermatological reactions, missed periods, or abnormal menstrual 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 2 reliable methods of birth control during therapy, during dose interruptions, and continuing for 4 weeks after completing therapy. Perform electrophysiologic testing every 6 months, and WBC with 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.

    PATIENT COUNSELING

    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 with 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 one highly effective form, simultaneously during therapy, during dose interruptions, and for 4 weeks after completing therapy. Instruct 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 with 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 and of need for prophylactic treatment. Inform that drowsiness may occur. Inform of other risks associated with therapy.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Do not open/crush cap. If powder contacts skin, wash immediately and thoroughly with soap and water; if powder contacts mucous membranes, flush thoroughly with water. Storage: 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). Store in blister packs until ingestion. Protect from light.