Rebif label now includes pregnancy outcomes, lactation information

June 05, 2020
The label for Rebif will no longer have the pregnancy category C designation and contains additional data to assist healthcare providers in assessing benefit versus risk and support counseling of pregnant women and nursing mothers. Patients should continue to notify their healthcare provider if they are pregnant or plan to become pregnant.

The update was based on data from a Nordic register-based study of 2,831 women, as well as a European registry and other published studies over several decades, which have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy. Findings regarding a potential risk for low birth weight or miscarriage with the use of interferon beta products in pregnancy have been inconsistent.

Previously, human data on breastfeeding during interferon beta treatment was not available. Now, new, albeit limited, data shows the presence of interferon beta-1a products in human milk at low levels, giving healthcare providers and their patients more information to assist with their decision making. There are no data on the effects of interferon beta-1a on milk production. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Rebif and any potential adverse effects on the breastfed child from Rebif or from the underlying maternal condition.

For more information on Rebif, including prescribing information, visit

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