Skin Cancer Home > Yervoy and Pregnancy

Because there are potentially serious risks, Yervoy (ipilimumab) is classified as a pregnancy Category C medicine. This means that women should only receive this drug if the benefits to the woman outweigh the risks to the unborn child. When the medication was given to pregnant monkeys, it caused miscarriages, stillbirth, and low birth weights.

Can Pregnant Women Receive Yervoy?

Yervoy™ (ipilimumab) is a prescription medication approved to treat a dangerous type of skin cancer known as melanoma. It is reserved for use when melanoma has spread in the body or cannot be treated surgically. This medication may not be safe for use during pregnancy.
 

What Is Pregnancy Category C?

Yervoy 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.
 
Yervoy has not been adequately studied in pregnant women. In animal studies, the drug was given to pregnant monkeys every 21 days throughout pregnancy at doses that were 2.5 to 7 times the standard human dose. In these studies, Yervoy caused miscarriage in the third trimester. It also increased the risk for stillbirth, low birth weight, and premature delivery in the monkeys.
 
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 drug may be given to a pregnant woman if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the fetus.
 
Written by/reviewed by:
Last reviewed by: Kristi Monson, PharmD;
Last updated/reviewed:
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