Cancer Home > Zortress and Pregnancy

It is not known whether it is safe for pregnant women to take Zortress (everolimus). Although this medicine has not been studied in pregnant women, animal studies have shown that the drug can increase the risk for miscarriage and cause fetal harm. Due to the potential risks, women should only take this medication during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Take Zortress?

Zortress® (everolimus) is a prescription medication used in certain people after a kidney or liver transplant. Based on the results of animal studies, this medication may not be safe for use during pregnancy.

What Is Pregnancy Category C?

Zortress is classified as a pregnancy Category C drug. 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.
Zortress has not been studied in pregnant women. However, the medicine caused fetal harm in animal studies. It increased the risk for miscarriage when given to pregnant rats and rabbits, even at low doses (doses approximately equal to one-third the usual human starting dose in rats and slightly less than the usual human starting dose in rabbits).
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Because of the potential risks associated with Zortress use during pregnancy, women of childbearing potential should use an effective form of birth control during treatment, and for up to eight weeks after stopping treatment.
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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