Xtandi and Pregnancy
Xtandi (enzalutamide) is not approved for use in women and could harm a fetus if taken during pregnancy. Although Xtandi has not been studied in pregnant humans or animals, it could cause abnormal development of a fetus. Also, it is recommended that men who are taking this drug use a condom when having sex with a partner who is pregnant.
Can Pregnant Women Take Xtandi?
Xtandi® (enzalutamide) is a prescription medication approved to treat certain men with prostate cancer. This drug is not approved for use in women and may harm an unborn child if taken by a pregnant woman. Xtandi has been given a pregnancy Category X classification based on its risks to the fetus.
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. Pregnancy Category X is given to medicines that show problems to the fetus in animal studies or in human use of the medication. With this category, the potential risks clearly outweigh the potential benefits.
Xtandi has not been studied in pregnant women or pregnant animals. However, based on the way the medication works, it can cause harm to a developing fetus. This is because Xtandi works by blocking the effects of androgens (male hormones), which could cause abnormal development, especially of a male fetus.
Xtandi should not be used in women who are pregnant or may become pregnant. It is probably safest for women who are pregnant or may become pregnant to avoid touching Xtandi capsules to prevent the possibility of any of the medicine from being absorbed through the skin.
At this time, it is unknown whether Xtandi will harm a developing fetus if used by a male partner during pregnancy. To help avoid any risk of harm, the manufacturer recommends that men use a condom when having sex with a partner who is pregnant during Xtandi treatment and for at least three months after treatment ends.
If a female partner is not currently pregnant but is of childbearing potential, the couple should use a condom and another form of birth control while the man is being treated with Xtandi and for at least three months after treatment ends.