Risk of severe, life-threatening birth defects caused by thalidomide.
For all people taking thalidomide:
Thalidomide must not be taken by women who are pregnant or who could become pregnant while taking this medication. Even a single dose of thalidomide taken during pregnancy can cause severe birth defects (physical problems present in the baby at birth) or death of the unborn baby. A program called Thalidomide REMS®(formerly known as the System for Thalidomide Education and Prescribing Safety [S.T.E.P.S.®]) has been approved by the Food and Drug Administration (FDA) to make sure that pregnant women do not take thalidomide and that women do not become pregnant while taking thalidomide. All people who are prescribed thalidomide, including men and women who cannot become pregnant, must be registered with Thalidomide REMS®, have a thalidomide prescription from a doctor who is registered with Thalidomide REMS®, and have the prescription filled at a pharmacy that is registered with Thalidomide REMS®in order to receive this medication.
You will need to see your doctor every month during your treatment to talk about your condition and any side effects you may be experiencing. At each visit, your doctor may give you a prescription for up to a 28-day supply of medication with no refills. You must have this prescription filled within 7 days.
Do not donate blood while you are taking thalidomide and for 4 weeks after your treatment.
Do not share thalidomide with anyone else, even someone who may have the same symptoms that you have.
For women taking thalidomide:
If you can become pregnant, you will need to meet certain requirements during your treatment with thalidomide. You need to meet these requirements even if you have a history of not being able to become pregnant. You may be excused from meeting these requirements only if you have not menstruated (had a period) for 24 months in a row, or you have had a hysterectomy (surgery to remove your uterus).
You must use two acceptable forms of birth control for 4 weeks before you begin to take thalidomide, during your treatment, and for 4 weeks after your treatment. Your doctor will tell you which forms of birth control are acceptable. You must use these two forms of birth control at all times unless you can guarantee that you will not have any sexual contact with a male for 4 weeks before your treatment, during your treatment, and for 4 weeks after your treatment.
Some medications can cause hormonal contraceptives to be less effective. If you plan to use hormonal contraceptives (birth control pills, patches, implants, injections, rings, or intrauterine devices) during your treatment with thalidomide, tell your doctor about all the medications, vitamins, and herbal supplements you are taking or plan to take. Be sure to mention: griseofulvin (Grifulvin); certain medications to treat human immunodeficiency virus (HIV) including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); certain medications for seizures including carbamazepine (Carbatrol, Equetro, Tegretol) and phenytoin (Dilantin, Phenytek); modafinil (Provigil); penicillin; rifampin (Rimactane, Rifadin); rifabutin (Mycobutin); and St. John's wort. Many other medications may interfere with the action of hormonal contraceptives, so be sure to tell your doctor all of the medications you are taking or plan to take, even those that do not appear on this list.
You must have two negative pregnancy tests before you can begin to take thalidomide. You will also need to be tested for pregnancy in a laboratory at certain times during your treatment. Your doctor will tell you when and where to have these tests.
Stop taking thalidomide and call your doctor right away if you think you are pregnant, you have a late, irregular, or missed menstrual period, you have any change in your menstrual bleeding, or you have sex without using two forms of birth control. In some cases, your doctor can prescribe emergency contraception ('the morning after pill') to prevent pregnancy. If you become pregnant during your treatment, your doctor is required to call the FDA and the manufacturer. Your doctor will also make sure you talk with a doctor who specializes in problems during pregnancy who can help you make choices that are best for you and your baby.
For men taking thalidomide:
Thalidomide is present in semen (fluid containing sperm that is released through the penis during orgasm). You must either use a latex or synthetic condom or completely avoid any sexual contact with a woman who is pregnant or may become pregnant while you are taking this medication and for 4 weeks after your treatment. This is required even if you have had a vasectomy (surgery to prevent sperm from leaving your body and causing pregnancy). Tell your doctor immediately if you have had unprotected sex with a woman who can become pregnant or if you think for any reason that your partner is pregnant.
Do not donate semen or sperm while you are taking thalidomide and for 4 weeks after your treatment.
Risk of blood clots:
If you are taking thalidomide to treat multiple myeloma (a type of cancer of the bone marrow), there is a risk that you will develop a blood clot in your arms, legs or lungs. This risk is greater when thalidomide is used along with other chemotherapy medications such as dexamethasone. Call your doctor immediately if you experience any of the following symptoms: pain, tenderness, redness, warmth, or swelling in the arms or legs; shortness of breath; or chest pain. Your doctor may prescribe an anticoagulant ('blood thinner') or aspirin to help stop clots from forming during your treatment with thalidomide.
Talk to your doctor about the risks of taking thalidomide.