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What should I discuss with my healthcare provider before taking lenalidomide (Revlimid)?
If you have certain conditions, you may need a dose adjustment or special tests to safely take this medication. Before taking lenalidomide, tell your doctor if you have:
It is not known if lenalidomide 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: If you have not had a hysterectomy or have not been in menopause for at least 24 months in a row, you will be required to use two forms of birth control beginning 4 weeks before you start taking lenalidomide and ending 4 weeks after you stop taking it. Even women with fertility problems are required to use birth control while taking this medication. You must also have a negative pregnancy test at 10 to 14 days before treatment and again at 24 hours before. While you are taking lenalidomide, you will have a pregnancy test every 4 weeks.
The birth control method you use must be proven highly effective, such as birth control pills, 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 lenalidomide 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 lenalidomide 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. Contact your doctor if you have had unprotected sex, even once, or if you think your female sexual partner may be pregnant.
Lenalidomide is available only under a special program called RevAssist. Under this program, only registered doctors and pharmacists can prescribe and dispense lenalidomide. 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 measures as required by the program.
For patients between 12 and 18 years, a parent or legal guardian must read all written requirements for the RevAssist program and sign the agreements on behalf of the patient.
How should I take lenalidomide (Revlimid)?
While you are using lenalidomide, 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 lenalidomide each time your prescription is refilled. You may continue getting refills only if you participate fully in the RevAssist program and commit to all agreements.
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.
This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Never give lenalidomide to another person, even if he or she has the same disorder for which you are being treated.
Your doctor may occasionally change your dose to make sure you get the best results from this medication.
Take each dose with a full glass of water.
Swallow the capsule whole, without breaking it open.
To be sure lenalidomide is helping your condition and not causing harmful effects, your blood will need to be tested every week for the first two months of treatment, and then every month after that. Do not miss any visits to your doctor.
Store lenalidomide at room temperature away from moisture and heat.
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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