Thalidomide Patient Information
Marketed under the brand name Thalomid by Celgene, thalidomide has roles in treating blood cancer and leprosy. Because the medication can cause fetal deformities and infant deaths, all patients and prescribers must take special precautions with thalidomide.
Uses
The U.S. Food and Drug Administration has approved thalidomide for the treatment and maintenance of remission from leprosy (erythema nodosum leprosum). Thalidomide also has an FDA-approved indication for use with dexamethasone for treating multiple myeloma, a cancer of the bone marrow.
S.T.E.P.S. Program
Patients and prescribers must participate in the System for Thalidomide Education and Prescribing Safety---S.T.E.P.S.---Program. Under the program, prescribers must receive special training, and female patients must use two forms of contraception and take at least monthly pregnancy tests. Male patients must use latex condoms during sex. All patients must receive oral and written information about thalidomide's risks and sign statements that they understand those risks and will follow all S.T.E.P.S. rules.
Warnings
Pregnant women cannot take thalidomide, because fetuses exposed to the drug can be born without arms or legs, short limbs, rubbery bones, missing bones, deformed ears, eye deformities and heart defects. As many as 40 percent of babies born to women taking thalidomide have been stillborn or died shortly after delivery. Other serious risks from taking thalidomide include blood clotting, nerve damage (peripheral neuropathy) and decreased white blood cell counts (neutropenia).
Common Side Effects
Expect dizziness, drowsiness and rash when taking thalidomide. Also watch for breathing problems (dyspnea), constipation, changes in blood counts, confusion, decreased salt in the bloodstream (hypornatremia), diarrhea, dry mouth, fatigue, fever, flatulence, headache, muscle weakness, sinusitis, skin infections, sore throat, swelling of feet and hands (edema) and yeast infections of the mouth. Alcohol and barbiturates enhance the somnolent effects of thalidomide.
Rare Serious Side Effects
Rarely, patients taking thalidomide have experienced abdominal swelling, anorexia, deafness, intestinal obstruction, liver swelling, kidney failure, leukemia, migraine, mood changes, nerve dysfunction (myasthenia), seizures, skin necrosis and slowed heartbeat (bradycardia).
Dosing
For multiple myeloma, take 200mg at bedtime with water and at least one hour after eating. For leprosy, take between 100mg and 400mg at bedtime as prescribed with water and at least one hour after eating. Do not handle thalidomide tablets extensively before taking them and keep thalidomide in a location where children cannot get to it.
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