Zaltrap and Pregnancy
Women of childbearing potential are usually recommended to use an effective form of birth control during chemotherapy treatment with Zaltrap (ziv-aflibercept). Because this drug caused birth defects and miscarriages during animal studies, it should only be given to a pregnant woman if the benefits to the mother outweigh the risks to her unborn child.
Zaltrap® (ziv-aflibercept) is a prescription medication approved for the treatment of colorectal cancer. Based on animal studies, Zaltrap may not be safe for use during pregnancy.
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. Zaltrap is classified as a pregnancy Category C medicine.
Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
Zaltrap has not been adequately studied in pregnant women. When given to pregnant rabbits, the drug caused miscarriages and a variety of birth defects, including heart defects, cleft palate (defects of the upper lip and roof of the mouth), and bone malformations. These problems occurred even at doses that were lower than the equivalent amount of the recommended human dose.
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, including Zaltrap, may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child. Because colon cancer can be fatal, a healthcare provider may recommend this drug for a pregnant woman despite the potential risks.
Because of the potential risks associated with using Zaltrap during pregnancy, it is recommended that both men and women of childbearing potential use an adequate form of birth control during treatment and for at least three months after the last Zaltrap dosage. Talk to your healthcare provider about the best possible birth control options for your particular situation.