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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 are the possible side effects of BETASERON®?7

  • Flu-like symptoms. Most patients have flu-like symptoms (fever, chills, sweating, muscle aches and tiredness). For many patients, these symptoms will lessen or go away over time. You should talk to your doctor about whether you should take an over-the-counter medication for pain or fever reduction before or after taking your dose of BETASERON (interferon beta-1b).
  • Skin reactions. Soreness, redness, pain, bruising or swelling may occur at the place of injection. (See What is the most important information I should know about BETASERON?)
  • Depression and anxiety. Some patients taking interferons have become very depressed and/or anxious. There have been patients taking interferons who have had thoughts about killing themselves. If you feel sad or hopeless, you should tell a friend or family member right away and call your doctor immediately. (See What is the most important information I should know about BETASERON?)
  • Liver problems. Your liver function may be affected. If you develop symptoms of changes in your liver, including yellowing of the skin and whites of the eyes and easy bruising, call your doctor immediately. (See What is the most important information I should know about BETASERON?)
  • 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.
  • Thyroid problems. Your thyroid function may change. Symptoms of changes in the function of your thyroid include feeling cold or hot much of the time or change in your weight (gain or loss) without a change in your diet or amount of exercise you are getting.
  • Allergic reaction. Some patients have had hives, rash, skin bumps or itching while they were taking BETASERON. There is also a rare possibility that you can have a life-threatening allergic reaction. (See What is the most important information I should know about BETASERON?)
  • Seizures. Some patients have had seizures while taking BETASERON, including 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 call your doctor right away. (See What is the most important information I should know about BETASERON?)
  • Heart problems. While BETASERON is not known to have any 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. (See What is the most important information I should know about BETASERON?)

Whether you experience any of these side effects or not, you and your doctor should periodically talk about your general health. Your doctor may want to monitor you more closely and ask you to have blood tests done more frequently. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.