Orencia and Pregnancy

In clinical studies on Orencia and pregnancy, the medication did not cause any birth defects or miscarriages when it was given to pregnant mice, rats, and rabbits. However, studies suggest that large doses of the drug may increase the risk of autoimmune disorders in the fetus. If you are taking Orencia and pregnancy occurs, your healthcare provider will weigh the benefits and risks before making a recommendation for your particular situation.

 

Orencia and Pregnancy: An Overview

Orencia® (abatacept) is a prescription rheumatoid arthritis medication. It may not be safe to use during pregnancy, although the full risks are not currently known.
 

Orencia and Pregnancy Category C

The U.S. Food and Drug Administration (FDA) uses a pregnancy 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. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
 
When Orencia was given to pregnant mice, rats, and rabbits, there was no increase in birth defects or miscarriages. However, large Orencia dosages occasionally caused changes in certain immune system cells that suggest that the drug may increase the risk of autoimmune disorders in the fetus.
 
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.
 
If you are pregnant or thinking of becoming pregnant while taking Orencia, let your healthcare provider know. Your healthcare provider will consider both the benefits and risks of using Orencia during pregnancy before making a recommendation for your particular situation.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;