FDA Updates Rebif Label on Pregnancy and Breastfeeding for MS Patients

The U.S. Food and Drug Administration (FDA) approved adding new safety data on pregnancy and breastfeeding to the U.S. label for Rebif (interferon beta-1a), a disease-modifying treatment for relapsing forms of multiple sclerosis (MS).

The label update draws on findings from a large population-based study, together with other studies published over several decades, and was done in accordance with the FDA’s Pregnancy and Lactation Labeling Rule. This rule provides prescribers with relevant information for critical decision-making when treating pregnant or lactating women.

The new Rebif label will no longer carry the pregnancy Category C designation to now include data that helps healthcare providers weigh treatment risk, and to support the counseling of pregnant women and nursing mothers.

EMD Serono, which markets Rebif in the United States and Canada (and is known elsewhere as Merck KGaA), said patients should continue to alert their doctors if they are pregnant or plan to become so.

“At EMD Serono, we are dedicated to supporting women with MS at every stage of their life journey, including when planning to start or expand their families,” Maria Rivas, MD, global chief medical officer and senior vice president at EMD Serono, said in a press release. “Today’s update provides physicians critical information to help inform women with MS in managing this chronic disease during a very important time in their lives.”

Given that more than half of women with relapsing MS are of childbearing age, pregnancy is a top consideration when choosing a treatment plan. The disease affects twice as many women as men, and is often diagnosed when patients are between ages 20 and 40. About one-third of female patients have discussed with their doctors plans to conceive within the next three years.

“Women with MS often have concerns and questions for their doctors about continuing disease-modifying treatments as they are trying to conceive, or if they do become pregnant,” said Maria Houtchens, MD, an associate professor of neurology at Brigham and Women’s Hospital.

“The inclusion of pregnancy outcomes and lactation data in the Rebif label provides valuable insights. I believe it will encourage discussions between physicians and their patients about MS treatment options when considering pregnancy,” Houtchens added.

This label update was based on data from a Finnish and Swedish health registry data study as well as the European Interferon Beta Registry and other past studies. All “have not identified a drug-associated risk of major birth defects with the use of interferon beta during early pregnancy,” the new label states. It is detailed in section 8.1 on pregnancy.

Results regarding a possible risk of miscarriage or low birth rate with the use of such therapies in pregnancy have been inconsistent.

Human data on breastfeeding during interferon beta treatment was previously unavailable. New, but limited, data now indicate the presence of interferon beta-1a products in human milk at low levels, providing physicians and patients with more information to help with decision-making.

Because there are no data on the effect of interferon beta-1a on milk production, EMD Serono emphasized that the developmental and health benefits of breastfeeding should be considered, as well as the mother’s clinical need for Rebif. Potential adverse effects on the breastfed child from Rebif or from the mother’s underlying condition should also be considered, the company said.

A subcutaneously (under-the-skin) administered therapy, Rebif decreases the frequency of relapse and delays the onset of some of the physical incapacity associated with MS.