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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

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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.