PROVENGE and Pregnancy

Because it is only approved for use in men, PROVENGE (sipuleucel-T) should not be given to a pregnant woman. This drug has not been studied in any pregnant women or animals, and the FDA has not given it a pregnancy category rating. Because of this lack of information, women should not receive this drug if they are pregnant.

Is PROVENGE Safe During Pregnancy?

PROVENGE® (sipuleucel-T) is a prescription prostate cancer medication. It works by using the body's immune system to fight the cancer cells. PROVENGE is only approved for use in certain men with prostate cancer. Therefore, pregnant women should not receive PROVENGE.
 

More Information About Pregnancy and PROVENGE

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. Most medications are assigned to a risk category based on animal or human studies, and on whether the potential risks of using the medication during pregnancy outweigh the potential benefits.
 
Currently, there is no information available on the use of PROVENGE in pregnant women. This medicine has not been studied in pregnant women or animals, and the FDA has not assigned the medication to a pregnancy category. Furthermore, this medication is not approved for use in women, including pregnant women.
 

Final Thoughts

PROVENGE is only recommended for use in men with certain types of prostate cancer.
 It should not be used in pregnant women.
Written by/reviewed by: Susan Lakey, PharmD, MPH
Last reviewed by: Kristi Monson, PharmD
 
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