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Gilenya and Pregnancy

The U.S. Food and Drug Administration has assigned a pregnancy Category C rating to Gilenya (fingolimod), which means that it may not be safe for pregnant women to use this medication. Some animal studies indicated that the drug might cause several problems, such as miscarriages and birth defects. However, your healthcare provider may prescribe this drug if the benefits outweigh the risks.

Can I Take Gilenya If I'm Pregnant?

Gilenya™ (fingolimod) is a prescription medication used to treat multiple sclerosis. Based on the results of animal studies, this drug may not be safe for use during pregnancy.
 

What Is 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.
 
In studies, giving high doses of Gilenya to pregnant animals increased the risk of birth defects and miscarriages. 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 the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
It takes up to two months for Gilenya to be completely cleared from the body. Therefore, women of childbearing potential should avoid becoming pregnant for at least two months after stopping Gilenya treatment.
 

Final Thoughts

If you are pregnant or thinking about becoming pregnant, let your healthcare provider know. He or she will consider both the benefits and risks of taking this drug during pregnancy before making a Gilenya recommendation in your particular situation.
 
Pregnancy and Pain

Gilenya Medication Information

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