What is relapsing-remitting MS?
Multiple sclerosis (MS) comes in a variety of types.6 BETASERON® (interferon beta-1b) is indicated to treat relapsing-remitting multiple sclerosis (RRMS), including those with clinically isolated syndrome (CIS), to reduce the frequency of clinical exacerbations7.
Clinically isolated syndrome (CIS)
CIS is defined as a first neurologic event suggestive of multiple sclerosis lasting for at least 24 hours and with symptoms and signs indicating either a single lesion (monofocal) or more than one lesion (multifocal) within the central nervous system8. BETASERON is FDA-approved to treat patients with clinically isolated syndrome and who have MRI features consistent with MS to reduce frequency of exacerbations.
Relapsing-remitting MS (RRMS)
Relapsing-remitting MS is the most common type of MS. About 85% of people with MS begin with RRMS.6 People with RRMS have temporary periods called relapses or flare-ups when new symptoms appear.6 Periods typically last a few days or weeks. At other times, the MS symptoms seem to disappear and this is called a remission; however, MS is still active and can progress. Damage to nerves can still occur even though there are no MS symptoms.6 BETASERON is FDA-approved to treat patients with relapsing-remitting multiple sclerosis to reduce frequency of clinical exacerbations.
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.
