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IMPORTANT SAFETY INFORMATION

BETASERON® (interferon beta-1b) should be used with caution in patients with depression. Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites...continue reading below

What is the most important information I should know about BETASERON®?

BETASERON (interferon beta-1b) will not cure multiple sclerosis (MS) but it has been shown to decrease the number of flare-ups of the disease. BETASERON can cause serious side effects, so before you start taking BETASERON, you should talk to your doctor about the possible benefits of BETASERON and its potential side effects to decide if BETASERON is right for you.

Potential serious side effects include7:

  • Depression. Some patients treated with interferons, including BETASERON, have become seriously depressed (feeling sad). Some patients have thought about or have attempted to kill themselves. Depression (a sinking of spirits or sadness) is not uncommon in people with multiple sclerosis. However, if you are feeling noticeably sadder or helpless, or feel like hurting yourself or others, you should tell a family member or friend right away and call your doctor or health care provider as soon as possible. Your doctor may ask that you stop using BETASERON. Before starting BETASERON, you should also tell your doctor if you have ever had any mental illness, including depression, and if you take any medications for depression.
  • Liver problems. Your liver may be affected by taking BETASERON and a few patients have developed severe liver injury. Your healthcare provider may ask you to have regular blood tests to make sure that your liver is working properly. If your skin or the whites of your eyes become yellow or if you are bruising easily, you should call your doctor immediately.
  • Risk to pregnancy. If you become pregnant while taking BETASERON, you should stop using BETASERON immediately and call your doctor. BETASERON may cause you to lose your baby (miscarry) or may cause harm to your unborn child. You and your doctor will need to decide whether the potential benefit of taking BETASERON is greater than the potential risks to your unborn child.

    A pregnancy registry has been established to monitor pregnancy outcomes of women exposed to BETASERON while pregnant. Providers are encouraged to obtain information online at www.BetaseronPregnancyRegistry.com and register patients by calling 1-800-478-7049.
  • Allergic reactions. Some patients taking BETASERON have had severe allergic reactions leading to difficulty breathing and swallowing; these reactions can happen quickly. Allergic reactions can happen after your first dose or may not happen until after you have taken BETASERON many times. Less severe allergic reactions such as rash, itching, skin bumps or swelling of the mouth and tongue can also happen. If you think you are having an allergic reaction, stop using BETASERON immediately and call your doctor.
  • Injection site problems. BETASERON may cause redness, pain or swelling at the place where an injection was given. A few patients have developed skin infections or areas of severe skin damage (necrosis). If one of your injection sites becomes swollen and painful or the area looks infected and it doesn't heal within a few days, you should call your doctor.
  • Seizures. Some patients have had seizures while taking BETASERON, including some patients who have never had seizures before. It is not known whether the seizures were related to the effects of their MS, to BETASERON, or to a combination of both. If you have a seizure while taking BETASERON, you should stop taking BETASERON and call your doctor right away.
  • Heart problems. While BETASERON is not known to have direct effects on the heart, a few patients who did not have a history of heart problems developed heart muscle problems or congestive heart failure after taking BETASERON. Some of the symptoms of heart problems are swollen ankles, shortness of breath, decreased ability to exercise, fast heartbeat, tightness in chest, increased need to urinate at night, and not being able to lay flat in bed. If you develop these symptoms or any heart problems while taking BETASERON, you should call your doctor right away.

INDICATIONS AND USAGE

BETASERON® (interferon beta-1b) is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

IMPORTANT SAFETY INFORMATION

  • BETASERON should be used with caution in patients with depression.
  • Injection-site necrosis has been reported in 4% of patients in controlled trials. Patients should be advised of the importance of rotating injection sites.
  • Severe hepatic injury, including cases of hepatic failure, has been reported. Patients should be monitored for liver enzyme elevations while taking BETASERON.
  • BETASERON should be used with caution in patients with seizure disorders or cardiac disease.
  • Female patients should be warned about the potential risk to pregnancy.
  • Cases of anaphylaxis have been reported rarely.
  • The most commonly reported adverse reactions are lymphopenia (low numbers of a certain kind of white blood cell), Injection-site reaction, asthenia (general weakness), flu-like symptom complex (flu syndrome and/or a combination of at least two Adverse Events from fever, chills, muscle aches, tiredness and sweating), headache and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms.

See "Warnings," "Precautions," and "Adverse Reactions" sections of full Prescribing Information.

For important risk and use information, please see the full Prescribing Information.

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