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Velcade and Pregnancy

Before receiving Velcade (bortezomib) during pregnancy, women should be aware of the risks this drug may pose to an unborn child. Animal studies have shown that this medicine may harm a fetus and cause complications like miscarriage and decreased fetal weight. As a pregnancy Category D medicine, Velcade should only be given to a pregnant woman if the benefits outweigh the risks.

Can Pregnant Women Use Velcade?

Velcade® (bortezomib) is a prescription chemotherapy medication approved for the treatment of multiple myeloma and mantle cell lymphoma. Velcade may harm an unborn child 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. Velcade is classified as a pregnancy Category D medicine.
Pregnancy Category D is given to medicines that have been shown to present a risk to the fetus in studies 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.
Velcade has not been adequately studied in pregnant women. In animal studies, the drug did not appear to cause birth defects when given to pregnant rats or rabbits at approximately half the usual recommended human dosage. However, there was an increased risk for miscarriage and decreased fetal weight in rabbits given the medication.
In general, this medicine should not be used in pregnant women unless absolutely necessary, such as in cases where a safer treatment option does not exist. Women who receive Velcade should use an effective form of birth control to prevent pregnancy throughout treatment. Your healthcare provider can talk to you about the best contraceptive method for your particular situation.
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