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Zelboraf and Pregnancy

Fetal harm may occur if a woman takes Zelboraf (vemurafenib) during pregnancy. This drug is classified as a pregnancy Category D medicine because it has the potential to interfere with cell growth, which is necessary for fetal development. However, there may be times where the benefits of taking Zelboraf may outweigh the risks to the fetus.

Can Pregnant Women Take Zelboraf?

Zelboraf™ (vemurafenib) is a prescription medication used in the treatment of advanced melanoma, a type of skin cancer. It is only approved for use in people who have an abnormal gene called the "BRAF" gene. As a pregnancy Category D medication, Zelboraf may harm an unborn baby 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. 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.
Zelboraf did not appear to cause birth defects or other problems when given to pregnant rats and rabbits in doses up to 1.3 times the normal human dose. However, the medication was found in the blood of the rat and rabbit fetuses, indicating it has the potential to pass from a pregnant mother to her unborn baby.
Because this medication has not been adequately studied in pregnant women, it is not entirely known what kind of problems it may cause in an unborn child. Zelboraf works by blocking the action of a certain protein that is important in cell growth. Because cell growth is necessary for fetal development, it is expected that this drug would cause fetal harm if taken during pregnancy.
There may be times when the benefits of treatment to a pregnant woman outweigh the possible risks of using this medication. Melanoma is a dangerous type of skin cancer. Therefore, it is possible that a healthcare provider may recommend Zelboraf during pregnancy if no other treatment options are available.
The manufacturer of Zelboraf recommends that women of childbearing potential and men with partners of childbearing potential use an effective form of birth control during Zelboraf treatment, and for at least two months after treatment ends. Talk to your healthcare provider about possible birth control options during Zelboraf treatment.
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Zelboraf Medication Information

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