Types of Multiple Sclerosis
BETASERON is indicated for patients with clinically isolated syndrome and have MRI features consistent with multiple sclerosis as well as Relapsing-Remitting Multiple Sclerosis.
Clinically Isolated Syndrome (CIS)
CIS (clinically isolated syndrome) 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 system.
Relapsing-Remitting Multiple Sclerosis (RRMS)
Relapsing-Remitting MS is the most common form of MS. About 75% to 85% of people with MS begin with RRMS.1
People with RRMS have temporary periods called relapses or flare-ups when new symptoms appear.1 Periods typically last a few days or weeks. At other times, the 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 symptoms.
BETASERON is not indicated for the following conditions, but these descriptions are included for your information.
Secondary-Progressive MS (SPMS)
In SPMS, symptoms steadily worsen with or without occasional relapses and remissions.1 Before disease-modifying therapies became available, about 50% of people with RRMS would progress to SPMS approximately 10 years after their first diagnosis.
Primary-Progressive MS (PPMS)
PPMS is a relatively rare type of MS (about 10% of people living with MS have this type) in which symptoms slowly, but continually, worsen from the beginning of the disease.1
Progressive-Relapsing MS (PRMS)
This is a rare type of MS (about 5% of people living with MS have this type) characterized by a steadily worsening disease state with acute relapses, with or without recovery.1
References:
- What is multiple sclerosis? National Multiple Sclerosis Society. http:www.nationalmssociety.org/about-multiple-sclerosis/what-is-ms/index.aspx. Accessed September 25, 2009.
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
The most commonly reported adverse reactions are lymphopenia, injection-site reaction, asthenia, flu-like symptom complex, headache, and pain. Gradual dose titration and use of analgesics during treatment initiation may help reduce flu-like symptoms. 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. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. See "Warnings," "Precautions," and "Adverse Reactions" sections of 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.
For important risk and use information, please see the full prescribing information.
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