Rebif® U.S. Label Now Includes Pregnancy Outcomes and Lactation Information to Help Inform Treatment Decisions for Women with MS
The inclusion of new pregnancy and lactation safety data in the prescribing information for Rebif® (interferon beta-1a) was approved in accordance with the FDA's Pregnancy and Lactation Labeling Rule (PLLR).
- Label update is based on data from a large register-based study, as well as other published studies over several decades
- Multiple sclerosis (MS) is a chronic disease affecting twice as many women as men and often is diagnosed during women's childbearing years(1)
- Pregnancy is a key treatment consideration as more than 50 percent of female patients with relapsing MS are of childbearing age(2)
ROCKLAND, Mass., May 27, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, announced today the U.S. Food and Drug Administration (FDA) has approved the inclusion of new safety data on pregnancy and breastfeeding in the prescribing information for Rebif® (interferon beta-1a), in accordance with the FDA's Pregnancy and Lactation Labeling Rule (PLLR). With a safety profile supported by 20+ years of combined clinical trial data and real-world patient experience, Rebif is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.3
Consistent with the new PLLR requirements, 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.
"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," said Maria Rivas, MD, Global Chief Medical Officer, SVP, EMD Serono. "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."
MS is a chronic disease affecting twice as many women as men and is often diagnosed between the ages of 20-40 years.1 Pregnancy is a key treatment consideration as more than 50 percent of female patients with relapsing MS are of childbearing age and an estimated one-third have discussed planning a pregnancy in the next three years with their healthcare provider.2
"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, Associate Professor of Neurology, Brigham and Women's Hospital, Boston. "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."
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.3
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.3
For more information on Rebif, including prescribing information, visit www.Rebif.com
About Rebif® (interferon beta-1a)
Rebif (interferon beta-1a) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. It is used to decrease the frequency of relapses and delay the occurrence of some of the physical disability that is common in people with MS.
IMPORTANT SAFETY INFORMATION:
Rebif is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, human albumin, or any other component of the formulation.
Rebif should be used with caution in patients with depression, a condition that is common in people with multiple sclerosis. Depression, suicidal ideation, and suicide attempts have been reported to occur with increased frequency in patients receiving interferon compounds, including Rebif.
Severe liver injury, including some cases of hepatic failure requiring liver transplantation, has been reported rarely in patients taking Rebif. The potential for liver injury should be considered when used in combination with other products associated with liver injury. Monitor liver function tests and patients for signs and symptoms of hepatic injury. Consider discontinuing Rebif if hepatic injury occurs.
Anaphylaxis and other allergic reactions (some severe) have been reported as a rare complication of Rebif. Discontinue Rebif if anaphylaxis occurs.
In controlled clinical trials, injection site reactions occurred more frequently in Rebif-treated patients than in placebo-treated and Avonex-treated patients. Injection site reactions including injection site pain, erythema, edema, cellulitis, abscess, and necrosis have been reported in the postmarketing setting. Do not administer Rebif into affected area until fully healed; if multiple lesions occur, discontinue Rebif until skin lesions are healed.
Decreased peripheral blood counts in all cell lines, including pancytopenia, have been reported in Rebif-treated patients. In controlled clinical trials, leukopenia occurred at a higher frequency in Rebif-treated patients than in placebo and Avonex-treated patients. Thrombocytopenia and anemia occurred more frequently in 44 mcg Rebif-treated patients than in placebo-treated patients. Patients should be monitored for symptoms or signs of decreased blood counts. Monitoring of complete blood and differential white blood cell counts is also recommended.
Cases of thrombotic microangiopathy (TMA), some fatal, have been reported with interferon beta products, including Rebif, up to several weeks or years after starting therapy. Discontinue Rebif if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated.
Caution should be exercised when administering Rebif to patients with pre-existing seizure disorders. Seizures have been temporally associated with the use of beta interferons, including Rebif, in clinical trials and in postmarketing reports.
The most common side effects with Rebif are injection-site disorders, headaches, influenza-like symptoms, abdominal pain, depression, elevated liver enzymes, and hematologic abnormalities.
Epidemiological data do not suggest a clear relationship between interferon beta use and major congenital malformations, but interferon beta may cause fetal harm based on animal studies. Data from a large human population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with 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.
Please see the full Prescribing Information for additional information: https://www.emdserono.com/us-en/pi/rebif-pi.pdf.
About Multiple Sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
EMD Serono, Inc. and Multiple Sclerosis
For more than 20 years, EMD Serono has been relentlessly focused on understanding the journey people living with MS face in order to create a meaningful, positive experience for them and the broader MS community. However, there is still much that is unknown about this complex and unpredictable disease. EMD Serono is digging deeper to advance the science.
About EMD Serono, Inc.
EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada - is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state of Massachusetts. www.emdserono.com.
1 Multiple Sclerosis: Hope Through Research. National Institutes of Health. https://www.ninds.nih.gov/disorders/patient-caregiver-education/hope-through-research/multiple-sclerosis-hope-through-research. Accessed April 16, 2020.
2 Data on file. EMD Serono, Inc.
3 Rebif [Prescribing Information]. Rockland, MA: EMD Serono, Inc.