Drugs Home > Afinitor and Pregnancy

Because Afinitor (everolimus) may cause harm to a fetus during pregnancy, the drug is considered a pregnancy Category D medicine. This means that women should only receive this drug if the benefits outweigh the risks. When Afinitor was given to pregnant animals, it caused miscarriages, problems with bone development in the fetus, and reduced the weight of the offspring.

Can Pregnant Women Take Afinitor?

Afinitor® (everolimus) is a prescription cancer medication. It is a pregnancy Category D medicine, which means it may harm an unborn child.

What Is Pregnancy Category D?

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 D is given to medicines that have been shown to present a risk to the fetus in studies of pregnant women, but may still offer benefits that outweigh the risks the drug presents.
A pregnancy Category D medicine may still be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
Afinitor has not been adequately studied in pregnant women. However, based on the actions of the drug, it may not be safe for use during pregnancy. In animal studies, Afinitor caused fetal harm even at low doses.
When given to pregnant rats and rabbits, Afinitor increased the risk for miscarriage. The drug also caused problems with bone development in the unborn rats. When given to rats during pregnancy and while breastfeeding, Afinitor reduced the weight of the offspring and slightly decreased offspring survival.
Because of the risks associated with Afinitor use during pregnancy, women of childbearing potential should use an effective form of birth control during treatment and for up to eight weeks after treatment ends. Your healthcare provider can help you choose the best birth control method for your situation.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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