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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 should I take BETASERON®?

BETASERON (interferon beta-1b) is given by injection under the skin (subcutaneous injection) every other day. Your BETASERON injections should be approximately 48 hours (two days) apart, so it is best to take them at the same time each day, preferably in the evening just before bedtime.

You may be started on a lower dose when you first start taking BETASERON. Your doctor will tell you what dose of BETASERON to use, and that dose may change based on how your body responds. You should not change your dose without talking with your doctor.

If you miss a dose, you should take your next dose as soon as you remember or are able to take it. Your next BETASERON injection should be taken about 48 hours (two days) after that dose. Do not take BETASERON on two consecutive days. If you accidentally take more than your prescribed dose, or take it on two consecutive days, call your doctor right away.

You should always follow your doctor's instructions and advice about how to take this medication. If your doctor feels that you, or a family member or friend may give you the injections, then you or the other person should be trained by your doctor or healthcare provider in how to give an injection. Do not try to give yourself (or have another person give you) injections at home until you (or both of you) understand and are comfortable with how to prepare your dose and give the injection.

Always use a new, unopened, vial of BETASERON and syringe for each injection. Never reuse vials or syringes.

It is important that you change your injection site each time BETASERON is injected. This will lessen the chance of your having a serious skin reaction at the spot where you inject BETASERON. You should always avoid injecting BETASERON into an area of skin that is sore, reddened, infected or otherwise damaged.

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.