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Adcetris and Pregnancy

There are risks involved if a pregnant woman receives Adcetris (brentuximab vedotin). When given to pregnant rats, this medicine increased the risk for miscarriage and caused certain malformations in the baby rats. Due to the risks, pregnant women should only receive this drug if the benefits outweigh the risks.

Can Pregnant Women Receive Adcetris?

Adcetris™ (brentuximab vedotin) is a prescription medication approved to treat Hodgkin's lymphoma and a rare type of lymphoma called systemic anaplastic large cell lymphoma (ALCL). This medicine may harm a developing fetus if used 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. Adcetris is classified as a pregnancy Category D drug.
 
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 her healthcare provider believes that the benefits to the woman outweigh the possible risks to her unborn child.
 
Adcetris has not been studied in pregnant women. However, based on the way the medicine works, as well as the results of animal studies, the drug is thought to have the potential to harm an unborn baby if taken by a pregnant woman.
 
In animal studies, Adcetris increased the risk for miscarriage when given to pregnant rats. It also caused umbilical hernia (when part of the intestine protrudes through an opening in the abdominal muscles) and malformations of the back legs in the baby rats.
 
In general, Adcetris should not be given to a pregnant woman, unless the benefits to the mother outweigh the potential risks to her unborn child. This may be the case if safer medicines are not an option. Women who are undergoing Adcetris treatment should use an effective form of birth control to avoid pregnancy.
 
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