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What should I discuss with my healthcare provider before taking thalidomide (Thalomid)?
If you have any of these conditions, you may not be able to take thalidomide, or you may need a dosage adjustment or special tests during treatment:
Thalidomide can cause severe, life-threatening birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. Even one dose of thalidomide can cause major birth defects of the baby's arms and legs, bones, ears, eyes, face, and heart. Never use thalidomide if you are pregnant.
It is not known if thalidomide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.
For Women: You will be required to use two reliable forms of birth control beginning 4 weeks before you start taking thalidomide and ending 4 weeks after you stop taking it. Any woman who has not had a hysterectomy or has not been in menopause for at least 24 months in a row must agree in writing to use birth control before, during, and after taking thalidomide. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test within 24 hours before you start thalidomide treatment. While you are taking thalidomide, you will need to have a pregnancy test weekly during the first month of treatment, and then every 4 weeks thereafter.
The birth control method you use must be proven highly effective: hormonal birth control (pills, implants, or injections), an intrauterine device (IUD), a tubal ligation, or a sexual partner's vasectomy. The extra form of birth control you use must be a barrier method such as a latex condom, a diaphragm, or a cervical cap.
Stop using thalidomide and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
For Men: You must not cause a woman to become pregnant while you are taking thalidomide because the medicine may affect your sperm and cause birth defects in the baby. You must agree in writing to always use latex condoms when having sex with a woman who is able to get pregnant, even if you have had a vasectomy. Avoid ejaculating without a condom because thalidomide can be passed in your sperm.
Thalidomide is available only under a special program called "System for Thalidomide Education and Prescribing Safety" (S.T.E.P.S.). You must be registered in the program and sign documents stating that you understand the dangers of this medication and that you agree to use birth control as required by the program. For patients between 12 and 18 years, a parent or legal guardian must read and sign all written requirements for the S.T.E.P.S. program. Do not give this medicine to a child younger than 12 years old.
How should I take thalidomide (Thalomid)?
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.
Swallow the capsule whole, without breaking it open.
Thalidomide is usually taken at bedtime. Take the medicine on an empty stomach, at least 1 hour after eating a meal.
While you are using thalidomide, you will be required to be listed on a patient registry and participate in occasional telephone surveys. You will be limited to a 28-day supply of thalidomide each time your prescription is refilled. You may continue getting refills only if you participate fully in the S.T.E.P.S. program and commit to all agreements.
Your doctor will need to check your progress on a regular basis. Do not miss any scheduled appointments.
You must not donate blood or sperm while you are using thalidomide. Avoid exposing another person to your blood or semen through casual or sexual contact.
Never give thalidomide to another person, even if he or she has the same disorder for which you are being treated.
Store thalidomide at room temperature away from moisture and heat. Keep each capsule in its blister pack until you are ready to take it.
Do not allow another person to handle your medicine without wearing disposable gloves. Caregivers should avoid handling broken capsules or inhaling the powder from a damaged capsule.
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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