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How does COPAXONE® work?

  • Relapsing MS is most commonly known for affecting the central nervous system (CNS), which is made up of the brain, spinal cord, and optic nerves. The CNS is affected through an abnormal response of the body's immune system.2

  • The immune system is made up of a network of cells, tissues, and proteins. There are many types of cells that play a part in the body’s immune response, one of which is called a T cell. In relapsing MS, inflammatory T cells attack the myelin that protects the nerve tissue in the CNS.2-4

  • COPAXONE® is thought to modify immune processes believed to be responsible for activating MS. Therapies approved to treat relapsing MS, as well as treatments currently being studied, are thought to have an impact on the immune system. Because COPAXONE® is thought to modify the immune system, it may interfere with immune functions. There is no evidence that COPAXONE® reduces the body's normal immune response, but this has not been systematically evaluated.1,5

  • Managing your MS is more than choosing a therapy that works today. As you age, immunosenescence (the aging of your immune system) should be considered—it can increase your risks for other serious conditions. That’s why managing your MS with a therapy that’s right for you is so important.6


Consider the results of 3-times-a-week COPAXONE® 40 mg, studied in the largest pivotal trial ever conducted for COPAXONE®.1

  • Primary study results: COPAXONE® 40 mg reduced the number of relapses compared with placebo (an inactive substance) at 12 months.

34% fewer relapses on COPAXONE® 40 mg compared with placebo. Relapses, also called flare-ups or attacks can cause new symptoms to occur and make old symptoms worse.
34 %

Fewer relapses compared with placebo1

Relapses, also called flare-ups or attacks, can cause new symptoms to occur and make old symptoms worse.7

Relapses, also called flare-ups or attacks, can cause new symptoms to occur and make old symptoms worse.7

  • Secondary study results: COPAXONE® 40 mg showed a significant reduction in the underlying disease activity as measured by brain lesions on magnetic resonance imaging (MRI) over 12 months compared with placebo.1

45% reduction in the total number of enhancing lesions on T1-weighted images. 45 %

Reduction in the total number of enhancing lesions on T1-weighted images1

T1-enhancing lesions, also known as gadolinium-enhancing T1 lesions, show areas where brain tissue is currently inflamed.8

T1-enhancing lesions, also known as gadolinium-enhancing T1 lesions, show areas where brain tissue is currently inflamed.8

35% reduction in the total number of new and enlarging T2 lesions. 35 %

Reduction in the total number of new and enlarging T2 lesions1

T2 lesions show areas where the brain tissue has been damaged.8

T2 lesions show areas where the brain tissue has been damaged.8

COPAXONE® STUDIED ACROSS 5 CLINICAL TRIALS1

For more about how COPAXONE® treats MS, visit our educational resources.

Use

COPAXONE® (glatiramer acetate injection) is prescription medicine used for the treatment of people with relapsing forms of multiple sclerosis (MS).

Important Safety Information

Do not take COPAXONE® if you are allergic to glatiramer acetate or mannitol.

Some patients report a short-term reaction right after or within minutes after injecting COPAXONE®. This reaction can involve flushing (feeling of warmth and/or redness), chest tightness or pain, fast heart beat, anxiety, and trouble breathing. These symptoms generally appear within seconds to minutes of an injection, last about 15 minutes, and do not require specific treatment. During the postmarketing period, there have been reports of patients with similar symptoms who received emergency medical care. If symptoms become severe, call the emergency phone number in your area. Call your doctor right away if you develop hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site. If any of the above occurs, do not give yourself any more injections until your doctor tells you to begin again.

Chest pain may occur either as part of the immediate post-injection reaction or on its own. This pain should only last a few minutes. You may experience more than one such episode, usually beginning at least one month after starting treatment. Tell your doctor if you experience chest pain that lasts for a long time or feels very intense.

A permanent indentation under the skin (lipoatrophy or, rarely, necrosis) at the injection site may occur, due to local destruction of fat tissue. Be sure to follow proper injection technique and inform your doctor of any skin changes.

The most common side effects of COPAXONE® include redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. These are not all of the possible side effects of COPAXONE®. For a complete list, ask your doctor or pharmacist. Tell your doctor about any side effects you have while taking COPAXONE®.

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.

Please see full Prescribing Information for Teva's COPAXONE®.

References:

  1. COPAXONE® (glatiramer acetate injection) Current Prescribing Information. Teva Neuroscience, Inc.

  2. Definition of MS. National Multiple Sclerosis Society (NMSS) website. https://www.nationalmssociety.org/What-is-MS/Definition-of-MS. Accessed November 18, 2018.

  3. T cells. National Multiple Sclerosis Society (NMSS) website. https://www.nationalmssociety.org/What-is-MS/Definition-of-MS/T-cells. Accessed November 18, 2018.

  4. What is an immune mediated disease? National Multiple Sclerosis Society (NMSS) website. https://www.nationalmssociety.org/What-is-MS/Definition-of-MS/Immune-mediated-disease. Accessed November 18, 2018.

  5. Bennett JL, Stüve O. Update on Inflammation, Neurodegeneration, and Immunoregulation in Multiple Sclerosis: Therapeutic Implications. Clin Neuropharmacol. 2009;32(3):121-132.

  6. Goronzy JJ, Weyand CM. Understanding immune senescence to improve vaccine responses. Nat Immunol. 2013;14(5):428-436.

  7. Managing relapses. National Multiple Sclerosis Society (NMSS) website. https://www.nationalmssociety.org/Treating-MS/Managing-Relapses. Accessed November 18, 2018.

  8. Magnetic resonance imaging (MRI). National Multiple Sclerosis Society (NMSS) website. https://www.nationalmssociety.org/Symptoms-Diagnosis/Diagnosing-Tools/MRI. Accessed November 18, 2018.

  9. Bornstein MB, Miller A, Slagle S, et al. A pilot trial of Cop 1 in exacerbating-remitting multiple sclerosis. N Engl J Med. 1987;317(7):408-414.

  10. Johnson KP, Brooks BR, Cohen JA, et al. Copolymer 1 reduces relapse rate and improves disability in relapsing-remitting multiple sclerosis: Results of a phase III multicenter, double-blind, placebo-controlled trial. Neurology. 1995;45(7):1268-1276.

  11. Comi G, Filippi M, Wolinsky JS; and the European/Canadian Glatiramer Acetate Study Group. European/Canadian Multicenter, Double- Blind, Randomized, Placebo-Controlled Study of the Effects of Glatiramer Acetate on Magnetic Resonance Imaging–Measured Disease Activity and Burden in Patients with Relapsing Multiple Sclerosis. Ann Neurol. 2001;49(3):290-297.

  12. Comi G, Martinelli V, Rodegher M, et al. Effect of glatiramer acetate on conversion to clinically definite multiple sclerosis in patients with clinically isolated syndrome (PreCISe study): a randomised, double-blind, placebo-controlled trial. Lancet. 2009;374(9700):1503-1511.

  13. US Department of Health and Human Services. Supplement approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020622s057ltr.pdf. Accessed November 18, 2018.

  14. Khan O, Rieckmann P, Boyko A, Selmaj K, Zivadinov R; for the GALA Study Group. Three times weekly glatiramer acetate in relapsing-remitting multiple sclerosis. Ann Neurol. 2013;73(6):705-713.

  15. US Department of Health and Human Services. Supplement approval. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf. Accessed November 18, 2018.

Injections for 3-times-a-week COPAXONE® 40 mg must be at least 48 hours apart.

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