GENERIC NAME: THALIDOMIDE - ORAL (tha-LID-oh-mide)
BRAND NAME(S): Thalomid
WARNING: Women who are pregnant must not use thalidomide. Women must avoid becoming pregnant while taking this medication. Even a single dose of thalidomide has caused severe (often fatal) birth defects when used during pregnancy. You must have a negative pregnancy test 24 hours before you start treatment with thalidomide, repeating the test at least monthly. Do not start or continue thalidomide treatment unless you have a negative pregnancy test result.
Female patients must use 2 effective forms of birth control (or completely avoid sexual intercourse) for 1 month before starting thalidomide, during use, and for 1 month after stopping this drug. Talk to your doctor about reliable birth control choices. If your period is late, or if you have sexual intercourse at any time without using 2 effective forms of birth control, stop taking this medication and contact your doctor immediately. (See also Precautions section.)
Because thalidomide also passes into semen, men who use this drug and have sex with women must use a latex condom during all sexual contact, even if they have had a vasectomy. Continue using condoms and other birth control as directed until 1 month after thalidomide treatment has been stopped.
Only patients who have signed an informed consent and agree to the requirements of the STEPS program may obtain and use thalidomide. Only physicians enrolled in STEPS may prescribe thalidomide, and only pharmacies enrolled in the program may dispense it. Consult your doctor or pharmacist for more details about the STEPS program and for more information about the risks and benefits of using this medication. These requirements apply in the United States. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.
When used to treat a certain type of cancer (multiple myeloma), thalidomide can increase the risk of serious blood clots in the legs or lungs, as well as heart attacks and strokes. Seek immediate medical attention if you develop shortness of breath, chest pain, jaw/neck/left arm pain, weakness on one side of your body, slurred speech, sudden vision changes, or arm/leg swelling. While you are taking thalidomide, your doctor may also direct you to take aspirin or other "blood thinners" (e.g., warfarin) to lessen the risk of these types of blood clots. Talk to your doctor for more information, and tell him/her if you have diabetes, high blood pressure or high cholesterol, kidney problems, or if you smoke. (See also Side Effects section.)
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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