Question

I have multiple sclerosis (MS), and I'm pregnant. Is it safe to take fingolimod?

Answer

The drug fingolimod (Gilenya) is sometimes prescribed for people with relapsing forms of multiple sclerosis (MS) to reduce flare-ups and ease symptoms. However, it may not be safe to take if you're pregnant. Based on animal studies, the Food and Drug Administration (FDA) has given fingolimod a pregnancy category C rating, indicating that it could harm your unborn baby.

As of yet, there are no adequate, well-controlled studies of fingolimod on pregnant women. A pregnancy registry has been established to track outcomes of fingolimod use during pregnancy, but the reported number of pregnancies is too few to form firm conclusions about using the drug during pregnancy. However, preliminary data indicate a possible risk of fingolimod-related developmental problems.

Fingolimod may take approximately two months to be completely eliminated from your body. Because of the potential risk to the baby while the drug is still in your system, the prescribing information advises women who may become pregnant to use effective contraception to avoid pregnancy during and for two months after stopping fingolimod treatment.

Last Updated: 06-07-2017
FAQ-20094098
content provided by mayoclinic.com
© 1998-2020 Mayo Foundation for Medical Education and Research (MFMER). All rights reserved. A single copy of these materials may be reprinted for noncommercial personal use only. "Mayo," "Mayo Clinic," "MayoClinic.com," "Mayo Clinic Health Information," "Reliable information for a healthier life" and the triple-shield Mayo logo are trademarks of Mayo Foundation for Medical Education and Research.