Last updated: October 23, 2014
Trade Names: Thalomid
Drug Class: Immunomodulator
Preparations: Capsule: 50-, 100-, 150-, 200 mg
Dose: 100–300 mg daily in divided doses; must only be administered in compliance with the REMS program
Indications: Erythema nodosum leprosum, myeloma, small, mostly uncontrolled reports have suggested possible benefit in severe recurrent refractory apthous stomatitis including ulcers associated with HIV and Behçet’s disease, and pyoderma gangrenosum and other refractory dermatological conditions
Mechanism of Action: Unknown; may inhibit angiogenesis and TNF
Contraindications: Pregnancy, hypersensitivity to thalidomide, childbearing potential and noncompliance with contraception, neutropenia
Precautions: May only be prescribed by physicians registered in the Thalidomid REMS program (formerly System for Thalidomide Education and Prescribing Safety (STEPS) program (see www.celgeneriskmanagement.com). If possible, avoid in women of childbearing potential; if not possible, ensure contraception for 4 weeks before and 4 weeks after therapy and a negative pregnancy test within 10-14 days and again within 24 hours of beginning treatment.
Monitoring: Monthly pregnancy tests, monthly assessment for peripheral neuropathy for 3 months and then periodically, consider electrophysiologic testing to monitor for neuropathy, monitor CBC periodically
Pregnancy Risk: X, highly teratogenic
Common: Peripheral neuropathy that may be permanent; this can occur after short-term use. Postural hypotension, dizziness, sleepiness. If used during pregnancy, causes birth defects such as phocomelia
Less common: Neutropenia, hypersensitivity including Stevens-Johnson syndrome, seizures, edema, rash, deep vein thrombosis, bradycardia, myocardial infarction and stroke
Drug Interactions: Increased sedation with sedatives and increased risk of bradycardia and peripheral neuropathy with drugs that cause those
Patient Instructions: Do not share the medication. Use two forms of contraception if a women and a latex condom if a man. This drug causes birth defects; do not become pregnant. Report changes in sensation in your hands and feet. Can cause sleepiness and dizziness on standing. Do not donate blood or sperm. Increased risk of blood clots.
Comments: Has limited potential for long-term use owing to frequent side effects, teratogenicity, lack of proven efficacy in rheumatic diseases, and the relapse of disease after discontinuation. Strategies to prevent fetal exposure to thalidomide are outlined in the REMS program; can only be prescribed by program-approved physicians.
Clinical Pharmacology: Peak concentrations at 4 hours; elimination half-life is 5 hours, largely through nonenzymatic hydrolysis
Hello M, Barbarot S, Bastuji-Garin S, Revuz J, Chosidow O. Use of thalidomide for severe recurrent aphthous stomatitis: a multicenter cohort analysis. Medicine 2010;89:176-82.PMID: 20453604.