On BETASERON

If you are currently on BETASERON^® treatment, you and your healthcare professional have made a smart choice. Even so, there may still be things you want or need to know about your therapy. In fact, there are a variety of ways that you can keep from feeling overwhelmed, especially when it comes to paying for BETASERON.

Below is a list of the most common questions about BETASERON treatment.

Can treatment with BETASERON wait until you "really need it"?

Even though you may not be experiencing any noticeable symptoms, MS causes your immune system to attack the nerves of your brain and spinal cord. The harm may be "silent," yet permanent damage may be occurring within your nervous system when you least expect it, even when you are unaware of any outward signs or symptoms. It's important to understand that MS can cause serious problems if left untreated. In fact, a study has suggested that MS can cause 4 times more damage during the first year than later on.¹ Since there is still no cure for MS, the goal of disease-modifying treatments such as BETASERON is to halt or slow the natural course of the disease and reduce the frequency of relapses.^2,3 Treatment with BETASERON cannot restore lost function, but it may slow future disease progression.^2,3 Remember: there's not a moment to lose—every moment BETASERON treatment is delayed. . . is a moment you may not get back.²

How does BETASERON work?

BETASERON helps fight relapsing forms of MS in the following ways:

• It blocks certain immune system cells—called T cells—from attacking myelin, the material that protects axons
• It stops certain types of proteins from activating the immune system to attack

How effective is BETASERON?

Based upon clinical studies, BETASERON is a proven safe and effective treatment for MS and has been trusted by patients and doctors alike for 17 years.^4,5

• BETASERON is a proven effective treatment for people with early MS²
• After 2 years in the BENEFIT study, patients treated with BETASERON were more likely to be free of MS episodes (or "flare-ups") than those in the untreated group²
• People with MS who took BETASERON continuously* for 12 years had fewer lesions than when they started BETASERON therapy
• In the INCOMIN trial, patients treated with BETASERON showed improvements in relapse rate, MS progression, and MRI outcomes⁷

Is BETASERON safe? What about long-term use?

Yes. BETASERON is the interferon with the longest record of clinical evidence.^4,5 It has been shown to be a safe and effective treatment for MS with more than 17 years of study.^4,5 And people who have been on BETASERON continuously* for 17 years have experienced a delay in the progress of their MS, giving them nearly 60% more "cane-free" years from the time of diagnosis.^†

What are the side effects of BETASERON?

The most commonly reported side effects of BETASERON include reactions at the site of injection, which may include redness, pain, and swelling; and flu-like symptoms, which may include chills, fever, fatigue, and muscle aches. Flu-like symptoms usually lessen over time. Healthcare providers have learned how to help reduce the risk of these symptoms by starting patients on a partial dose of BETASERON and gradually increasing to the full dose over several weeks.⁸ This process, called "titration," gives patients time to adjust to the medicine.⁸ Taking over-the-counter pain relievers such as acetaminophen (Tylenol^®), ibuprofen (Motrin^®) or naproxen sodium (Aleve^®) before injection may also help reduce the severity of these symptoms.⁸

Other side effects may include depression, elevated liver enzymes, and low white blood cell counts.⁸ Clinical data suggest that very few people stop taking MS therapies due to side effects.²

In the BETASERON BENEFIT study, 93% of the patients completed the study compared with the placebo group.² Additionally, 96% of all patients who completed the BENEFIT study chose to continue with BETASERON as part of a 3-year follow-up study.² The BENEFIT study results reflect this in relation to BETASERON—people who start with BETASERON, stay with BETASERON.²

What about pregnancy and BETASERON?

The effects of BETASERON on a fetus are not known. If you become pregnant while on BETASERON, or you plan to become pregnant, speak to your healthcare professional immediately about stopping treatment.⁸

Can you take other medicines while on BETASERON?

Yes, you can take other medications while taking BETASERON, however, it is extremely important to make sure that all of your healthcare providers are aware that you are taking BETASERON before they prescribe additional medications for you.⁸

Is it easy to take BETASERON when you travel?

Yes. Traveling is often a concern for people with MS. BETASERON is the only MS medication that does not need to be kept refrigerated.^‡ There's no need to plan on keeping BETASERON refrigerated in luggage or in a hotel room during travel. And because BETASERON can be stored at room temperature, there's no waiting for it to warm up before injection,⁸ unlike other refrigerated therapies for which a 20- to 30-minute warming period is suggested before injection.^9,10,11

With BETASERON, patients can inject immediately, giving them the freedom to administer their medication when it is most convenient for them. This means greater flexibility and peace of mind for you when traveling. If you're traveling by air, always keep your medication with you on the plane. Avoid packing it in checked luggage, which could get lost. Passing BETASERON through normal x-ray exposures during travel (ie, security checks) should pose no risk to the BETASERON formulation. (You may be asked for a note from your healthcare professional explaining why you are traveling with injectables). It is also important to note that, as the only MS disease-modifying therapy that is refrigeration-free^‡, BETASERON may also be safely and easily stored out of the reach of children.

Starting treatment on BETASERON can be more easily managed by taking the right steps with the help of your healthcare professional. Get some tips for Starting BETASERON

Tylenol is a registered trademark of McNeil Consumer Healthcare, a Division of McNeil PPC, Inc. Motrin is a registered trademark of McNeil Consumer Healthcare, a Division of McNeil PPC, Inc. Aleve is a registered trademark of Bayer HealthCare LLC. Avonex is a registered trademark of Biogen Idec, Inc. Rebif is a registered trademark of EMD Serono, Inc.

*Continuous use is defined as >80% of the study duration.

^†Compared with people on other DMTs or receiving no treatment.

^‡BETASERON is the only immunomodulatory MS therapy that can be stored at room temperature for longer than 30 days. After reconstitution, if not used immediately, the product should be refrigerated and used within 3 hours.

1. 1. Kuhlmann T, Lingfeld G, Bitsch A, Schuchardt J, Brück W. Acute axonal damage in multiple sclerosis is most extensive in early disease stages and decreases over time. Brain. 2002;125:2202-2212
2. 2. Kappos L, Polman CH, Freedman MS, et al, for the BENEFIT Study Group. Treatment with interferon beta-1b delays conversion to clinically definite and McDonald MS in patients with clinically isolated syndromes. Neurology. 2006;67:1242-1249.
3. 3. National Multiple Sclerosis Society (NMSS). MS the disease. Available at: http://www.nationalmssociety.org/site/PageServer?pagename=HOM_PRESS_ms_the_disease Accessed July 2007.
4. 4. Goodin DS, Ebers G, Traboulsee A, Konieczny A, for the Betaseron^® LTF Study Group. The interferon beta-1b 16-year long-term follow-up study: clinical outcomes. Poster. Presented at the 131st Annual Meeting; October 8-11, 2006; Chicago, IL.
5. 5. . Ebers G, Traboulsee A, Langdon D, Goodin D, Konieczny A, for the Betaseron^®/Betaferon^® LTF Study Group. The interferon beta-1b 16-year long-term follow-up study: the results. Poster. Presented at the 58th American Academy of Neurology Annual Meeting; April 1-8, 2006; San Diego, CA.
6. 6. Rice GPA, Nicole E, Lesaux J, Ebers GC, Kremenchutzky M, Karlik S. Long term safety, compliance and evolution of neutralizing antibodies in MS patients treated with interferon beta 1b. Poster. Presented at the 17th Congress of European Committee for Treatment and Research in Multiple Sclerosis; September 12-15, 2001; Dublin, Ireland.
7. 7. Durelli L, Verdun E, Pierangelo B, et al, and the Independent Comparison of Interferon (INCOMIN) Trial Study Group. Every-other-day interferon beta-1b versus once-weekly interferon beta-1a for multiple sclerosis: results of a 2-year prospective randomised multicentre study (INCOMIN). Lancet. 2002;359:1453-1460.
8. 8. Betaseron [package insert]. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2007.
9. 9. Rebif [package insert]. Rockland, MA: Serono, Inc; 2005.
10. 10. Copaxone [package insert]. Kansas City, MO: Teva Neuroscience, Inc.; 2006.
11. 11. Avonex [package insert]. Cambridge, MA: Biogen Idec Inc.; 2006.