Benlysta and Pregnancy
As a pregnancy Category C drug, Benlysta (belimumab) may be used under certain circumstances during pregnancy. However, the full risks are unclear, and animal studies suggest that the drug may cause problems. For women of childbearing potential, the manufacturer of Benlysta recommends using adequate birth control not only during treatment, but for four months after treatment ends.
Benlysta® (belimumab) is a prescription medication approved to treat systemic lupus erythematosus. Based on information from animal studies, this medication may not be safe for use during pregnancy.
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 studied in pregnant humans but do appear to cause harm to the fetus 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.
Benlysta has not been adequately studied in pregnant women, although it is known that the drug can pass through the placenta to the developing child. In animal studies, the drug was given to pregnant monkeys. In these studies, it appeared to increase the risk of fetal death and newborn death.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
At this time, the manufacturer recommends that women of childbearing potential use adequate birth control while using Benlysta and for four months after stopping the drug.