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IMPORTANT SAFETY INFORMATIONSafety InformationMedication Guide

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... continue reading below

How BETASERON Works

How BETASERON Works

BETASERON will not cure your multiple sclerosis (MS), but it can help decrease how often you experience flare-ups.1

Flare-ups (also called a relapse or exacerbation) may cause damage to your nerves. Once that damage occurs, it may be irreversible.2

So, the fewer flare-ups, the better.

BETASERON is thought to fight relapsing forms of MS by1:

  • 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 unknown1

Could BETASERON be right for you?

If you have had a first event suggestive of MS, take a look at the BENEFIT study. In the 2-year BENEFIT study, immediate treatment with BETASERON® (interferon beta-1b) delayed conversion to clinically definite MS (CDMS).†2

  • Immediate treatment delayed conversion by 50% overall (P<.0001)
  • 55% when used in monofocal patients (P=.0004)
  • 60% in patients with <9 T2 lesions at baseline (P <.0006)2

The most common interferon beta-1b associated adverse events (AEs) were injections site reactions and flu-like symptoms. The frequency of both AEs were substantially lower in the second year.2

Speak to your healthcare provider to find out if BETASERON is right for you.

Concerns about injection site reactions?

In four controlled clinical trials, injection site reactions occurred in 78% of patients receiving BETASERON, with injection site necrosis in 4%. The incidence of injection site reactions tended to decrease over time. Approximately 69% of patients experienced the event during the first three months of treatment, compared to approximately 40% at the end of the studies.

These effects may be reduced by rotating injection sites.

BETAPLUS the patient support program created by Bayer offers 24/7 nurse support to help patients manage these reactions.

In the head-to-head BEYOND study, BETASERON patients reported 20% fewer injection site reactions compared to Copaxone. Flu-like symptoms were more prevalent in the BETASERON arm of the study, but were transient in nature and decreased over time.†† 3 ISRs are commonly reported side effects, however, BETAPLUS offers 24/7 nurse support to help patients manage these reactions.

† The BENEFIT Study evaluated the efficacy and safety of BETASERON in CIS patients. 292 patients received BETASERON and 176 patients received placebo, for a total of 468 patients in the study.

†† The BEYOND study examined the differences between a BETASERON dose of 250 mcg and 500 mcg and Copaxone (glatiramer acetate) 20 mg dose. 897 patients received Betaseron 250 mcg, 899 patients received Betaseron 500 mcg, and 448 received Copaxone 20 mg for a total of 2244 patients.

References:
  1. Betaseron [package insert]. Montville, NJ: Bayer HealthCare Pharmaceuticals Inc; 2009.
  2. Kappos L, Polman CH, Freedman MS, et al. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006; 67:1242-9.
  3. O'Connor P, Filippi M, Arnason B, et al ; for the BEYOND Study Group. 250 mcg or 500 mcg interferon beta-1b versus 20 mg glatiramer acetate in relapsing-remitting multiple sclerosis: a prospective, randomised, multicentre study. Lancet Neurol. 2009 Sep 1. [Epub ahead of print]
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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** In a survey of 199 physicians conducted by JZM/Phoenix Healthcare Practice, BETAPLUS, an MS patient support program for those on Betaseron, was rated "best" for affordable therapy, copay assistance, and nurse access and training, compared to MS support programs from Avonex, Copaxone, and Rebif. Attitude, Awareness and Use Tracking Study Among Physicians June 2008.

Consider MS Treatments
When considering treatments, take a closer look at BETASERON.
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