Ilaris and Pregnancy

During animal studies, giving Ilaris (canakinumab) to pregnant monkeys and mice caused delays in fetal bone development. Because of these potential problems, the FDA classified the drug as a pregnancy Category C medicine, meaning it may not be safe for use during pregnancy. However, there may be times where the benefits of using Ilaris during pregnancy may outweigh the risks.

Can Pregnant Women Receive Ilaris?

Ilaris® (canakinumab) is a prescription medication used to treat people who have cryopyrin-associated periodic syndromes (CAPS), a group of rare genetic conditions that include familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS). It is also approved for systemic juvenile idiopathic arthritis (SJIA). Based on animal studies, this medication may not be safe for use during pregnancy.
 

What Is Pregnancy Category C?

Ilaris 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 used 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.
 
Ilaris has not been studied in pregnant women. However, it has been studied in pregnant animals. In these animal studies, Ilaris was shown to delay fetal bone development when given to pregnant monkeys in high doses. Delays in bone development were also seen in fetal mice when a medication similar to Ilaris was given to pregnant mice.
 
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.
 
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