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
Why Early Treatment Matters
Studies suggest that MS causes damage in the early years of the disease.1,2
Interferons are proteins that affect immune system activity.
BETASERON (interferon beta-1b) is a type of protein called interferon that occurs naturally in the body. Interferons are proteins whose properties mainly affect the activity of the immune system.7
BETASERON (interferon beta-1b) is an FDA-approved interferon beta treatment to reduce flare-ups in patients with relapsing forms of multiple sclerosis (MS) including those who have experienced a first clinical episode and have MRI features consistent with MS.7
The way BETASERON works is unknown. BETASERON will not cure your MS but may help decrease how often you experience multiple sclerosis flare-ups. Flare-ups (also called relapses or exacerbations) may cause damage to your nerves.7
BETASERON is thought to reduce RRMS relapses by:
Blocking certain immune system cells—called T cells—from attacking myelin, the material that protects your nerve fibers
Stopping certain types of proteins from activating the immune system to attack your myelin
The exact mechanism of action of interferon beta-1b in patients with multiple sclerosis is unknown.7
The BENEFIT study
The 2-year BENEFIT study evaluated the efficacy and safety of BETASERON in patients with clinically isolated syndrome (CIS). 292 patients received BETASERON and 176 patients received placebo, for a total of 468 patients in the study.7
The BENEFIT study findings:
In the study, BETASERON reduced the risk of conversion to clinically definite MS (CDMS) by 50% overall compared with the placebo group.7,8
Common adverse events (AEs) associated with BETASERON include injection-site reactions and flu-like symptoms.7
The frequency of flu-like symptoms may decrease over time with gradual dose titration and the use of over-the-counter analgesics.7,8
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.
