Who should not take BETASERON®?
Do not take BETASERON (interferon beta-1b) if you:
Have had allergic reactions such as difficulty breathing, flushing or hives to another interferon beta or to human albumin.7
If you have any of the following conditions or serious medical problems, you should tell your doctor before taking BETASERON7:
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Depression (a sinking feeling or sadness), anxiety (feeling uneasy, nervous, or fearful for no reason), or trouble sleeping
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Liver diseases
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Problems with your thyroid gland
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Blood problems such as bleeding or bruising easily and anemia (low red blood cells) or low white blood cells
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Epilepsy
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Heart problems
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Are pregnant, breast feeding, or planning to become pregnant
You should tell your doctor if you are taking any other prescription or nonprescription medicines. This includes any vitamin or mineral supplements, or herbal products.
What should I avoid while taking BETASERON?7
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Pregnancy. You should avoid becoming pregnant while taking BETASERON until you have talked with your doctor. BETASERON can cause you to lose your baby (miscarry).
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Breast feeding. You should talk to your doctor if you are breast feeding an infant. It is not known if the interferon in BETASERON can be passed to an infant in mother's milk, and it is not known whether the drug could harm the infant if it is passed to an infant.
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.
