Erivedge and Pregnancy
Because taking Erivedge (vismodegib) during pregnancy could cause potentially serious harm to a fetus, women must have a pregnancy test done before they take this drug to make sure they are not pregnant. Also, women or men who are taking this medication should use a highly effective form of birth control during treatment and for several months after the last dose.
Can Pregnant Women Take Erivedge?Erivedge™ (vismodegib) is a prescription medication used in the treatment of advanced basal cell carcinoma, the most common type of skin cancer. Based on the way it works in the body, this medicine could harm an unborn child if taken by a pregnant woman.
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. Erivedge is classified as a pregnancy Category D medication.
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 drug may still be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
There are no adequate studies of Erivedge in pregnant women. However, it has been studied in pregnant animals. In these studies, Erivedge caused a variety of birth defects, including defects of the head, face, and fingers and toes when given to pregnant mice in doses that were lower than the equivalent recommended human dose. When given to mice in higher doses, the drug increased the risk for miscarriage.
In addition, based on how it works, Erivedge may cause harm to a developing fetus. This drug works by inhibiting a pathway in the body called the hedgehog pathway. The hedgehog pathway plays an important role in regulating the growth and development of tissues and organs in early life, and normally becomes less active in adulthood. However, abnormal activities of proteins in the hedgehog pathway in adulthood are thought to be involved in cancer cell growth.
If you are a woman of childbearing potential, your healthcare provider will give you a pregnancy test within seven days of beginning treatment to see if you are pregnant. If you are not pregnant, you should use a highly effective form of birth control throughout Erivedge treatment and for at least seven months after receiving your last dose. Your healthcare provider can help you choose the most effective birth control for your particular situation.
It is also recommended that men taking Erivedge use a condom with spermicide when having sexual intercourse with a female partner of childbearing potential -- both throughout treatment and for at least two months after the last Erivedge dosage is taken. This includes men who have had a vasectomy.
It is important that you contact your healthcare provider as soon as possible if you are taking Erivedge and have unprotected sex, believe your birth control may have failed, or think you may be pregnant (or, if you are a male, your female partner may be pregnant). Also, contact your healthcare provider if you become pregnant within seven months of stopping the drug.