NULOJIX and Pregnancy

It is unknown whether it is safe for pregnant women to receive NULOJIX (belatacept). Although this medicine has not been studied in pregnant women, animal studies have shown that the drug could increase the risk of infections and other problems. Due to the potential risks, women should only take this medication during pregnancy if the benefits outweigh the risks.

Can Pregnant Women Receive NULOJIX?

NULOJIX® (belatacept) is a prescription medication used in people who have received a kidney transplant. At this time, it is unclear if the drug is safe for use during pregnancy.

What Is Pregnancy Category C?

NULOJIX is classified as a pregnancy Category C drug. 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 C is given to medicines that have not been adequately studied in pregnant humans but have caused fetal harm in animal studies.
In addition, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
NULOJIX has not been studied in pregnant women. In animal studies, NULOJIX did not cause birth defects when given to pregnant rats and rabbits in very high doses. However, when given to rats during pregnancy and while breastfeeding, the drug caused death in some of the mother and baby rats. The death in the mother rats was due to an increased risk for infections. There were no observed problems in the rat offspring that survived.
However, it is important to note that animals do not always respond to medicines in the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to her unborn child.
Pregnancy and Pain

NULOJIX Medication Information

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