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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® is a prescription medicine that is used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Important Safety Information

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

Serious side effects may happen right after or within minutes after you inject COPAXONE® at any time during your course of treatment. Call your doctor right away if you have any of these immediate post-injection reaction symptoms including: redness to your cheeks or other parts of the body (flushing); chest pain; fast heart beat; anxiety; breathing problems or tightness in your throat; or swelling, rash, hives, or itching. If you have symptoms of an immediate post-injection reaction, do not give yourself more injections until a doctor tells you to.

You can have chest pain as part of an immediate post-injection reaction or by itself. This type of chest pain usually lasts a few minutes and can begin around 1 month after you start using COPAXONE®. Call your doctor right away if you have chest pain while using COPAXONE®.

Damage to the fatty tissue just under your skin’s surface (lipoatrophy) and, rarely, death of your skin tissue (necrosis) can happen when you use COPAXONE®. Damage to the fatty tissue under your skin can cause a “dent” at the injection site that may not go away. You can reduce your chance of developing these problems by following your doctor’s instructions for how to use COPAXONE® and choosing a different injection area each time you use COPAXONE®.

The most common side effects of COPAXONE® include redness, pain, swelling, itching, or a lump at the injection site; rash; shortness of breath; flushing; and chest pain.

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of COPAXONE®. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects.

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 read the Patient Information in the full Prescribing Information.

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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