Nexavar and Pregnancy

As a pregnancy Category D drug, Nexavar (sorafenib) is usually not recommended for use during pregnancy because it may cause fetal harm. In animal studies, the drug was shown to increase the risk of miscarriage and other problems, even in small doses. This chemotherapy drug may also cause problems with the development of the baby's circulatory system.

Can Pregnant Women Take Nexavar?

Nexavar® (sorafenib) is a prescription medication used to treat certain types of cancer. As a pregnancy Category D drug, Nexavar may cause fetal harm if taken during pregnancy.
 

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 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 be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh the possible risks to the unborn child.
 
Nexavar has not been studied in pregnant women. When given to pregnant rats and rabbits, the drug caused problems, including miscarriage, even in low doses.
 
One of the actions of Nexavar is to prevent the development of new blood vessels. However, new blood vessels are needed to create the circulatory system in a developing child. Based on this action of the medication and the results of animal studies, Nexavar may likely be harmful to the fetus if taken during pregnancy.
 
The manufacturer recommends that women of childbearing potential and men with partners of childbearing potential use an effective form of birth control during Nexavar treatment, and for at least two weeks after treatment ends. Talk to your healthcare provider about birth control options while you are taking this drug.
 
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Nexavar Medication Information

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