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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

References

  1. Adherence. National Multiple Sclerosis Society Web site. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/treatments/adherence/index.aspx. Accessed May 13, 2011.
  2. Kuhlmann T, Lingfeld G, Bitsch A, Schuchardt J, Bruck W. Acute axonal damage in multiple sclerosis is most extensive in early disease stages and decrease over time. Brain. 2002;125:2202-2212.
  3. Frankel D, James H. Living With Multiple Sclerosis. New York, NY: National Multiple Sclerosis Society; 2011. http://www.nationalmssociety.org/download.aspx?id=48. Accessed December 13, 2011.
  4. Who gets MS? National Multiple Sclerosis Society Web site. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/who-gets-ms/index.aspx. Accessed December 13, 2011.
  5. Epidemiology of MS. National Multiple Sclerosis Society Web site. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/who-gets-ms/epidemiology-of-ms/index.aspx. Accessed December 13, 2011.
  6. What is multiple sclerosis? National Multiple Sclerosis Society Web site. http://www.nationalmssociety.org/about-multiple-sclerosis/what-we-know-about-ms/what-is-ms/index.aspx. Accessed May 13, 2011.
  7. BETASERON (prescribing information). Montville, NJ: Bayer HealthCare Inc; 2011.
  8. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67:1242-1249.
  9. Avonex® [package insert]. Cambridge, MA: Biogen Idec Inc; 2006.
  10. Copaxone® [package insert]. Kansas City, MO: Teva Neuroscience, Inc; 2007.
  11. Rebif® [package insert]. Rockland, MA: Serono, Inc; 2005.
  12. Gilenya™ (prescribing information). East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2010.

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.