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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

How can I help manage some common side effects?

Doctor (Dr. Eng)
Experiencing side effects? Talk to your doctor.

Two of the most commonly reported side effects of BETASERON® (interferon beta-1b) are injection-site reactions (ISRs) and flu-like symptoms (fever, chills, sweating, muscle aches, and tiredness). You can help make them more manageable with the right techniques.

Here are some tips to help you manage these common side effects7,8:

  • Take an over-the-counter pain reliever. To help relieve flu-like symptoms, about an hour before you inject take an over-the-counter pain reliever as recommended by your doctor. You may also consider taking BETASERON right before going to bed.
  • Titrate (gradually increasing your dose). Your doctor may start you on a lower dose of BETASERON, then increase it gradually. This can help your body adjust to therapy.
  • Rotate your injection sites. To help manage injection site reactions, never use the same injection site twice in a row. If an area is sore, red, infected, or swollen, use another area and call your doctor. Learn how to rotate your injection sites

Speak to your healthcare provider for other ways to help you manage side effects.

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.