Bayer Updates Betaseron (interferon beta-1b) Prescribing Information in Accordance with the U.S. Food and Drug Administration's Pregnancy and Lactation Labeling Rule

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Dec 17, 2018, 09:00 ET

WHIPPANY, N.J., Dec. 17, 2018 /PRNewswire/ -- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved the inclusion of new safety data on pregnancy in the prescribing information for Betaseron^® (Interferon beta 1b, IFNß-1b), which is indicated for the treatment of relapsing remitting multiple sclerosis (RRMS). The label update is based on prospective data collected from U.S. and international pregnancy exposure registries and is in accordance with the FDA's Pregnancy and Lactation Labeling Rule (PLLR).

"Young women diagnosed with RRMS often have many questions about whether to continue treatment when they want to start a family or are concerned when an unplanned pregnancy happens while on treatment," said Mark Rametta, D.O., FACOI, FACP, Medical Director, Neurology at Bayer. "We hope information included in the FDA label update will encourage discussion between physicians and their patients and provide answers for doctors to discuss with women who plan to start a family or who have a recently confirmed pregnancy."

In addition to the observational studies submitted to the FDA, Bayer also provided data from its global and U.S. Betaseron^® pharmacovigilance database, which gathered and were prospective data over several years on the risk of IFNß-1b for women who are planning to become pregnant or are pregnant. The data show a similar rate of birth defects and spontaneous abortions (i.e., miscarriage) in pregnant women exposed to IFNβ-1b in comparison with available general population worldwide estimates.^i,ii

Until recently, data about RRMS treatment with IFNß-1b used until or during pregnancy have been limited. The results of different prospective and observational registries provide important information for healthcare providers and patients.ⁱⁱⁱ

Betaseron is a prescription medicine used to reduce the number of relapses in people with relapsing remitting forms of multiple sclerosis. This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. Betaseron will not cure MS but may decrease the number of flare-ups of the disease. In controlled clinical trials, the most common adverse reactions (at least 5% more frequent on Betaseron than on placebo) were: injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia.

For full Betaseron prescribing information, click here.

INDICATIONS

BETASERON® (interferon beta-1b) is a prescription medicine used to reduce the number of relapses in people with relapsing forms of multiple sclerosis (MS). This includes people who have had their first symptoms of multiple sclerosis and have an MRI consistent with multiple sclerosis. BETASERON will not cure MS but may decrease the number of flare-ups of the disease.

IMPORTANT SAFETY INFORMATION

Do not take BETASERON (interferon beta-1b) if you are allergic to interferon beta-1b, to another interferon beta, to human albumin, or mannitol.

BETASERON can cause serious side effects, including:

Liver Problems Including Liver Failure. Symptoms of liver problems may include yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea or vomiting, bruising easily or bleeding problems. Your healthcare provider will do blood tests to check for these problems while you take BETASERON.

Serious Allergic Reactions. Serious allergic reactions can happen quickly and may happen after your first dose of BETASERON or after you have taken BETASERON many times. Symptoms may include difficulty breathing or swallowing, swelling of the mouth or tongue, rash, itching, or skin bumps.

Depression or Suicidal Thoughts. Call your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse or worry you: thoughts about suicide or dying, new or worse depression (sinking feeling or sadness), new or worse anxiety (feeling uneasy, nervous or fearful for no reason), trouble sleeping (insomnia), acting aggressive, being angry, or violent, acting on dangerous impulses, hallucinations, other unusual changes in behavior or mood.

Other possible serious side effects with BETASERON include:

Heart Problems. BETASERON may worsen heart problems including congestive heart failure. Symptoms of heart problems may include swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, not being able to lay flat in bed.

Injection Site Problems. Serious skin reactions can happen in some people including areas of severe damage to skin and the tissue below the skin (necrosis). These reactions can happen anywhere you inject BETASERON. Symptoms of injection site problems may include swelling, redness, or pain at the injection site, fluid drainage from the injection site, breaks in your skin or blue-black skin discoloration. Change your injection site each time you inject BETASERON as it will lessen the chance of you having a serious skin reaction. Avoid injecting BETASERON into an area of the skin that is sore, reddened, infected or has other problems.

Flu-like Symptoms. BETASERON can cause flu-like symptoms including fever, chills, tiredness, sweating, muscle aches when you first start to use it. These symptoms may decrease over time. Taking medicines for fever and pain relief on the days you are using BETASERON may help decrease these symptoms.

Seizures. Some people have had seizures while taking BETASERON, including people who have never had seizures before. It is not known if the seizures were related to MS, to BETASERON, or to a combination of both. If you have a seizure after taking BETASERON call your healthcare provider right away.

Blood Problems. You may have a drop in the levels of infection-fighting white blood cells, red blood cells, or cells that help you form blood clots. If drops in levels are severe, they can lessen your ability to fight infections, make you feel tired or sluggish or cause you to bruise or bleed easily.

Pregnancy:
Tell your doctor if you are pregnant or plan to become pregnant.

Most Common Side Effects:
The most common side effects of BETASERON include low white blood cell count, increases in your liver enzymes, headache, increase in your muscle tension, pain, rash, problems sleeping, stomach pain, weakness. These are not all the possible side effects of BETASERON.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Tell your healthcare provider about all the medicines you take and your medical conditions.

Please see the full Prescribing Information and Medication Guide for additional information and talk to your healthcare provider.

You are encouraged to report side effects or quality complaints of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Betaseron^®(Interferon beta 1b, IFNß-1b)

Upon FDA approval in 1993, Betaseron was the first disease-modifying drug introduced for RRMS. Since then, Bayer has been proud to lead the fight against relapsing MS through not only the availability of Betaseron, but through comprehensive resources and innovative support tools it offers the patient community.

In 2015, Bayer introduced Betaconnect, the first auto-injector for Betaseron, which provided technology and intuitive design to the patient's treatment experience. It became part of the Betaconnect system, along with the myBETAapp, which was introduced in 2017. For more information about Betaseron, visit www.betaseron.com.

Updated pregnancy section in the FDA approved prescribing information for Betaseron®:

8.1 Pregnancy

Risk Summary
Although there have been no well-controlled studies in pregnant women, available data, which includes prospective observational studies, have not generally indicated a drug-associated risk of major birth defects with interferon beta-1b during pregnancy.

Administration of BETASERON to monkeys during gestation resulted in increased embryofetal death at or above exposures greater than 3 times the human therapeutic dose (see Animal Data).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The background risk of major birth defects and miscarriage for the indicated population is unknown.

Human Data
The majority of the observational studies reporting on pregnancies exposed to interferon beta-1b did not identify an association between the use of interferon beta-1b during pregnancy and an increased risk of major birth defects.

Animal Data
When BETASERON (doses ranging from 0.028 to 0.42 mg/kg/day) was administered to the pregnant rhesus monkeys throughout the period of organogenesis (gestation days 20 to 70), a dose-related abortifacient effect was observed. The low- effect dose is approximately 3 times the recommended human dose of 0.25 mg on a body surface area (mg/m2) basis. A no-effect dose for embryo-fetal development toxicity in rhesus monkeys was not established.

8.2 Lactation

Risk Summary
There are no data on the presence of BETASERON in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.

The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BETASERON and any potential adverse effects on the breastfed child from BETASERON or from the underlying maternal condition.

Bayer: Science for a Better Life

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2017, the Group employed around 99,800 people and had sales of EUR 35.0 billion. Capital expenditures amounted to EUR 2.4 billion, R&D expenses to EUR 4.5 billion. For more information, go to www.bayer.us.

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Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

ⁱ Coyle PK, Sinclair SM, Scheuerle AE, et al. Final results from the Betaseron (interferon beta-1b) Pregnancy Registry: a prospective observational study of birth defects and pregnancy-related adverse events. BMJ Open 2014;4: e004536.
ⁱⁱ Sandra Thiel, Annette Langer-Gould, Milena Rockhoff, Aiden Haghikia, Annette Queisser-Wahrendorf, Ralf Gold and Kerstin Hellwig: Interferon-beta exposure during first trimester is safe in women with multiple sclerosis—A prospective cohort study from the German Multiple Sclerosis and Pregnancy Registry Multiple Sclerosis Journal, 2016, Vol. 22 (6) 801-809.
ⁱⁱⁱ Sandra Thiel, Annette Langer-Gould, Milena Rockhoff, Aiden Haghikia, Annette Queisser-Wahrendorf, Ralf Gold and Kerstin Hellwig: Interferon-beta exposure during first trimester is safe in women with multiple sclerosis—A prospective cohort study from the German Multiple Sclerosis and Pregnancy Registry Multiple Sclerosis Journal, 2016, Vol. 22 (6) 801-809.