Everolimus and Pregnancy

It may not be safe for pregnant women to take everolimus. Animal studies have shown that the drug can increase the risk for miscarriage and cause fetal harm. Due to the potential risks, low-dose everolimus is classified as a pregnancy Category C medicine, and the high-dose version is a Category D drug. Women should only take this drug during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Take Everolimus?

Everolimus (Afinitor®, Zortress®) is a prescription medication used in high doses to treat certain types of cancer and certain kidney and brain tumors in people with a rare condition known as tuberous sclerosis. In low doses, everolimus is used to help prevent organ rejection in people who have had a kidney or liver transplant.
Everolimus may not be safe for use during pregnancy. The low-dose version of the medicine (Zortress) is a pregnancy Category C medicine, while the high-dose version (Afinitor) is a pregnancy Category D medicine.

What Are Pregnancy Categories C and 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 C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Pregnancy Category D is a classification 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 her unborn child.
Everolimus has not been studied in pregnant women. However, in animal studies, the drug caused fetal harm. Everolimus increased the risk for miscarriage when given to pregnant rats and rabbits, even at low doses, and caused defects in bone development in the baby rats. When given to female rats during pregnancy and while breastfeeding, everolimus reduced the weight of the offspring and decreased offspring survival.
Because of the potentially harmful effects of everolimus 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 recommend an effective birth control option for your particular situation.
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Everolimus Drug Information

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