thalidomide, Thalomid

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GENERIC NAME: thalidomide

BRAND NAME: Thalomid

DRUG CLASS AND MECHANISM: Thalidomide is an oral medication used for treating the skin conditions of leprosy, a disease caused by a parasite, Mycobacterium leprae. The mechanism of action of thalidomide is not well understood. The immune system reaction to Mycobacterium leprae plays an important role in producaing the skin manifestations of leprosy. Scientists believe that thalidomide modifies the reaction of the immune system to Mycobacterium leprae and thereby suppresses the skin reaction. Thalidomide also is being evaluated as a treatment for HIV and several other conditions. Thalidomide was approved by the FDA in July 1998.



PREPARATIONS: Capsules: 50, 100, 150, and 200 mg

STORAGE: Thalidomide should be store at room temperature 15-30 C (59-86 F) and protected from light.

PRESCRIBED FOR: Thalidomide is used for the treatment and prevention of skin conditions resulting from leprosy (erythema nodosum leprosum) and for treating multiple myelomas. Thalidomide has also been used off-label for treating mycobacterium tuberculosis (TB), aphthous ulcers, HIV-wasting syndrome, Crohn's disease, and Kaposi's sarcoma.

DOSING: The recommended adult dose is 100-400 mg daily for treatment of leprosy. The dose for treating multiple myeloma is 200 mg daily in combination with dexamethasone. Thalidomide should be administered in the evening at least one hour after meals and with a full glass of water.

DRUG INTERACTIONS: Thalidomide increases the sedative effect of alcohol and other drugs that cause drowsiness (for example, diazepam [Valium]). Drugs that slow heart rate add to the heart slowing effects of thalidomide. Examples of such drugs include calcium channel blockers (CCBs), beta blockers, and digoxin (Lanoxin). The incidence of peripheral neuropathy increases when thalidomide is combined with other drugs (for example, amiodarone [Cordarone], cisplatin, phenytoin [Dilantin, Dilantin-125]) that also cause peripheral neuropathy.

PREGNANCY: Thalidomide is very harmful to the fetus. Therefore, thalidomide should be avoided during pregnancy. Men and women who are taking thalidomide should use appropriate methods of birth control. Moreover, women of childbearing age should practice two forms of birth control concurrently. Men taking thalidomide should not donate sperm, and thalidomide users should not donate blood since the recipients of the sperm and blood may receive small amounts of thalidomide.

URSING MOTHERS: It is not known whether thalidomide is excreted in breast milk.

SIDE EFFECTS: The most common side effects are drowsiness, headache, dizziness, low blood pressure, weakness, and rash. Impotence, diarrhea, constipation, and increased sensitivity to sunlight may also occur. Thalidomide also causes nerve damage (peripheral neuropathy), slow heart rate, hypertension, hypotension, and a decrease in white blood cells. Symptoms of nerve damage are tingling, numbness and pain in the feet or hands.

Reference: FDA Prescribing Information

Last Editorial Review: 6/27/2012

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