If you have relapsing multiple sclerosis (RMS) and are thinking about starting a family, it’s important to plan ahead. Talk with your healthcare provider about your options for treating RMS while you are trying to become pregnant, and ask if Rebif® may be a good choice for you.
Based on the pregnancy registry data described below, Rebif® is thought to be appropriate to continue taking while family planning up until you become pregnant, but you should tell your healthcare provider right away if you suspect you’ve become pregnant. The study did not identify an increased risk of major birth defects associated with use of interferon beta during early pregnancy, but it is not known if Rebif® may harm your unborn baby.
Before you take Rebif®, tell your healthcare provider if:
You are pregnant or plan to become pregnant. It is not known if Rebif® will harm your unborn baby
You are breastfeeding or plan to breastfeed. Rebif® may pass into breastmilk. Talk with your healthcare provider about the best way to feed your baby if you take Rebif®
The possible effects of interferon beta during pregnancy were evaluated in a pregnancy registry. This registry tracked the outcomes of 2,831 pregnancies of women with multiple sclerosis in Finland from 1996 to 2014 and Sweden from 2005 to 2014.
Early in their pregnancies, some women were exposed to interferon beta, including Rebif® (n=797 pregnancies), while others were not exposed to any disease-modifying drugs (n=1,647 pregnancies).
a drug-associated risk of major birth defects among the women exposed to interferon beta in early pregnancy
– OR –
an increased risk of miscarriage or ectopic pregnancy. However, limitations in obtaining complete data capture for these outcomes made the interpretation of these findings more difficult
If you are planning to get pregnant, it is important to talk with your healthcare provider about managing your risk of RMS relapses (flare-ups) before, during, and after pregnancy.
IMPORTANT SAFETY INFORMATION AND INDICATION
Important Safety Information
Do not take Rebif if you are allergic to interferon beta, human albumin, or any of the ingredients in Rebif.
Rebif can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking Rebif.
Before you take Rebif, tell your healthcare provider if you have or have had any of the following conditions:
Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
The most common side effects of Rebif include:
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Rebif. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Rebif® (interferon beta-1a) is a prescription medicine used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is not known if Rebif is safe and effective in children.