Thalidomide

A to Z Drug Facts

 Action Immunomodulatory agent, mechanism of action not fully understood.

 Indications Acute treatment of cutaneous manifestations of moderate-to-severe erythema nodosum leprosum (ENL); maintenance therapy for prevention and suppression of cutaneous manifestations of ENL recurrence.

 Contraindications Pregnancy.

 Route/Dosage

ADULTS: PO Initial dose 100 to 300 mg daily, preferably 1 hour after the evening meal. 400 mg daily at bedtime or in divided doses ³ 1 hour after meals may be given to patients with severe cutaneous ENL reaction or to those who have previously required higher doses to control reaction.

 Interactions

Barbiturates, chlorpromazine, ethanol, reserpine: The sedative effect of these drugs may be enhanced.

 Lab Test Interferences None well documented.

 Adverse Reactions

CV: Bradycardia; hypertension; hypotension; vasodilation; orthostatic hypotension; peripheral vascular disorder; tachycardia. CNS: Drowsiness; somnolence; peripheral neuropathy; dizziness; agitation; insomnia; nervousness; paresthesia; tremor; vertigo; headache; malaise; abnormal thinking; agitation; amnesia; anxiety; causalgia; circumoral paresthesia; confusion; depression; euphoria; hyperesthesia; neuralgia; neuropathy; psychosis. DERM: Rash; acne; fungal dermatitis; nail disorder; pruritus; maculopapular rash; sweating; alopecia; dry skin; eczematous rash; exfoliative dermatitis; chthyosis; perifollicular thickening; skin necrosis; seborrhea; urticaria; esiculobullous rash. EENT: Amblyopia; deafness; dry eyes; eye pain; sinusitis; tinnitus. GI: Anorexia; constipation; diarrhea; dry mouth; flatulence; nausea; oral moniliasis; tooth pain; abdominal pain. GU: Albuminuria; hematuria; impotence; decreased creatinine clearance; orchitis; roteinuria; pyuria; urinary frequency; acute renal failure. HEMA: Neutropenia; leukopenia; decreased erythrocyte sedimentation rate; eosinophilia; granulocytopenia; hypochromic anemia; leukemia; leukocytosis; levated mean cell volume; abnormal RBC; palpable spleen; thrombocytopenia; rythroleukemia; myelogenous leukemia. HEPA: Abnormal liver function tests; increased AST. META: Hyperlipidemia; inappropriate antiduretic hormone; increased alkaline phosphatase; amyloidosis; bilirubinemia; increased BUN; cyanosis; diabetes; bnormal electrolytes; hyperkalemia; hyperuricemia; hypocalcemia; hypoproteinemia; ncreased LDH; decreased phosphate. RESP: Pharyngitis; rhinitis; cough; emphysema; epistaxis; pulmonary embolus; rales; upper respiratory tract infection; voice alteration. OTHER: Teratogenicity; hypersensitivity; HIV viral load increase; lymphadenopathy; ccidental injury; asthenia; back pain; chills; edema; peripheral edema; facial edema; fever; infection; neck pain; neck rigidity; pain; arthritis; bone tenderness; ypertonia; joint disorder; leg cramps; myalgia; myasthenia; periosteal disorder; nlarged abdomen; photosensitivity; upper extremity pain.

 Precautions

Pregnancy: Category X. Lactation: Undetermined. Children: Safety and efficacy in children < 12 years of age not established. Females: Contraindicated in women of childbearing potential unless alternative therapies are inappropriate and patient meets the following conditions (ie, unable to become pregnant while on thalidomide): Understands and can carry out instructions; capable of complying with mandatory contraceptive measures, pregnany testing, patient registration, and patient survey described in System for Thalidomide Education in Prescribing Safety (STEPS) program; received both oral and written warning of hazards of taking thalidomide during pregnancy and of exposing fetus to drug; received oral and written warnings or risk of possible contraception failure and need to use 2 reliable forms of contraception simultaneously, unless continuous abstinence from reproductive heterosexual intercourse is chosen (sexually mature women who have not undergone hysterectomy or who have not been postmenopausal for ³ 24 consecutive months [ie, who have had menses at some time in the preceding 24 consecutive months] are considered to be of childbearing potential); acknowledges in writing understanding of these warnings and of need for using 2 reliable methods of contraception for 1 month prior to starting thalidomide therapy, during therapy, and for 1 month after stopping thalidomide; has had negative pregnancy test with sensitivity of ³ 50 mIU/ml within 24 hours of starting therapy; parent or legal guardian reads this material and agrees to ensure compliance with above for patients between 12 and 18 years of age. Males: Contraindicated in sexually mature males unless the following: Understands and can carry out instructions; capable of complying with mandatory contraceptive measures appropriate for men; patient registration and patient survey as described in STEPS program; received both oral and written warnings of risk of possible contraception failure and of need for barrier contraception in women of childbearing potential (latex condom [even if has undergone vasectomy]); acknowledges in writing understanding of these warnings and the need for barrier contraception; arent or legal guardian reads this material and agrees to ensure compliance with above for patients between 12 and 18 years of age. Hypersensitivity: Has been reported. Peripheral neuritis: Not indicated as monotherapy for ENL treatment in presence of moderate-to-severe neuritis. Photosensitivity: May occur; avoid exposure to sunlight or UV light. Prescribers/Dispensers: May only be prescribed and dispensed by individuals in the STEPS program.

 Administration/Storage

• Store in closed container protected from light at 15° to 30°C (59° to 86°F).

 Assessment/Interventions

• Anticipate dosing with thalidomide until signs and symptoms of active reaction have subsided, usually a period of ³ 2 weeks. Patients are then tapered off the medication.
• Obtain patient history, including drug history and any known allergies.
• Monitor patient for possible adverse or hypersensitivity reactions and drug-drug interactions.
• Assess Hansen's disease patients for therapeutic effectiveness indicated by control of cutaneous manifestations of erythema nodosum leprosum.
• Assess patient for signs and symptoms of peripheral neuropathy. If present, discontinue treatment.
• Monitor patient's white blood cell count and differential for neutropenia.
• Monitor patients with HIV for increased plasma HIV RNA.

 Patient/Family Education

• Instruct patient to take thalidomide only as prescribed in compliance with the provisions of the STEPS restricted program.
• Instruct patient that under no circumstances should this drug be shared with anyone.
• Instruct patient that thalidomide often causes drowsiness and somnolence and to not drive an automobil, operate dangerous machinery, or engage in activities that require mental alertness and coordination until reaction to this drug is known.
• Instruct patient not to take any other medications including those that might cause drowsiness without medical advice.
• Caution patient that thalidomide may potentiate somnolence caused by alcohol.
• Instruct patient to report any numbness, tingling, pain, or burning sensation in the feet or hands immediately to their health care provider as these may be signs of peripheral neuropathies.
• Instruct patient to avoid excessive exposure to the sun and UV light, and to wear protective clothing and sunscreen.
• Instruct patient to sit upright for a few minutes before standing up to prevent falls.
• Instruct patient not to donate blood while taking thalidomide.
• Instruct male patients not to donate sperm.
• Effective measures of birth control must be used by men and women l month prior, during, and 1 month after thalidomide has been discontinued. Men must use condoms when engaging in sex.
• Instruct women that even a single dose taken by a pregnant woman could cause severe birth defects and explain the types of birth defects.
• Warn patient of the precautions that must be taken to preclude fetal exposure as per the STEPS program and boxed warnings.

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Copyright © 2003 Facts and Comparisons
David S. Tatro
A to Z Drug Facts