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Revlimid and Pregnancy

It is crucial that Revlimid (lenalidomide) not be taken during pregnancy, as this drug can cause severe birth defects and even fetal death. To prevent this from happening, a nonmenopausal woman must take pregnancy tests before taking this drug and frequently during treatment. In addition, women of childbearing potential must use two forms of birth control while taking this medication.

Can Pregnant Women Take Revlimid?

Revlimid® (lenalidomide) should not be taken by pregnant women or women who may become pregnant. This is because the medication can cause birth defects or even death in an unborn child.

What Is Pregnancy Category X?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Revlimid has been given a pregnancy Category X classification.
Pregnancy Category X is given to medicines that show fetal problems in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
When given to pregnant monkeys, Revlimid caused defects of the limbs in the offspring. Revlimid is similar to the medication thalidomide (Thalomid®), which is known to cause severe birth defects. Because giving this medication to pregnant women would be unethical, Revlimid has never been studied in women who are expecting.
Because Revlimid is similar to thalidomide, it is expected to be unsafe for use during pregnancy. Women of childbearing potential must have two negative pregnancy tests before starting treatment. The first test will be given within 10 to 14 days of the first dose and the second test within 24 hours of the first dose.
Once treatment is started, pregnancy tests will be given weekly during the first month of Revlimid treatment, and then every two weeks in women with irregular menstrual cycles and every month in women with regular menstrual cycles.
If you are a woman of childbearing potential, it is very important that you use effective birth control for at least four weeks before starting Revlimid, while taking the medication, and for at least four weeks after your last dose. Therefore, women of childbearing potential must agree to abstain from intercourse or use two forms of birth control.
One of the two birth control methods should be a highly effective method, such as birth control pills, tubal ligation, or an intrauterine device (IUD). Talk to your healthcare provider about the best forms of birth control for your situation. Progestin-only pills ("mini-pills") are not considered to be highly effective.
In addition, Revlimid is found in semen. Therefore, men taking the medication must agree to use a latex condom during sex with a woman of childbearing potential throughout treatment, and for at least four weeks after treatment ends. Men taking Revlimid should also not donate sperm during treatment and for at least four weeks after treatment ends, as the sperm could cause birth defects.
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Revlimid Medication Information

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