HOW DOES COPAXONE^® WORK?

COPAXONE^® (glatiramer acetate injection) is used to treat relapsing forms of multiple sclerosis (MS). It is an injection made with glatiramer acetate, which is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. Patients taking COPAXONE^® may see results in 12 months.¹

HOW RELAPSING MULTIPLE SCLEROSIS (RMS) AFFECTS YOUR BODY

RMS 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 RMS, inflammatory T cells attack the myelin that protects the nerve tissue in the CNS.^2,3

COPAXONE^® AND YOUR IMMUNE SYSTEM

COPAXONE^® is thought to modify immune processes believed to be responsible for activating MS. Therapies approved to treat relapsing RMS, 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.^1,4,5

MS THERAPY AND IMMUNOSENESCENCE

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 compared with placebo^1,7

Relapses, also called flare-ups or attacks, can cause new symptoms to occur and make old symptoms worse.⁸

Relapses, also called flare-ups or attacks, can cause new symptoms to occur and make old symptoms worse.⁶

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.^1,7

45 ^%

Reduction in the total number of enhancing lesions on T1-weighted images^1,7

T1-enhancing lesions, also known as gadolinium-enhancing T1 lesions, show areas where brain tissue is currently inflamed.⁹

35 ^%

Reduction in the total number of new and enlarging T2 lesions^1,7

T2 lesions show areas where the brain tissue has been damaged.⁹

COPAXONE^® STUDIED ACROSS 5 CLINICAL TRIALS¹

A 27-year study of the active ingredient in COPAXONE® found long-term safety results¹⁶

Some participants from the clinical trial of COPAXONE® opted into a long-term, open-label extension (OLE) study, which means that all participants were aware of the drug being tested. The OLE study looked at the safety and efficacy of the drug over time.

All participants were randomized and categorized as follows:

Entered the OLE:
208 out of 251 (82.9%)

Completed the OLE:
24 out of 101 (23.8%, Early Start)
28 out of 107 (26.2%, Delayed Start up to 3 years)

Sustained results in treating RMS were found with earlier initiation of glatiramer acetate. Safety and efficacy were both necessary for FDA approval and Teva has continued to prioritize these for over 25 years.¹⁶

42.0

32.4

40.3

31.6

Up to year 25Full study period

% of participants with stable/improved EDSS

Early start (ES)

Delayed start (DS)

KEY: EDSS: Expanded Disability Status Scale

The Expanded Disability Status Scale (EDSS) is a way of measuring how much someone is affected by their MS. You might hear your neurologist talk about it or see it mentioned in reports on trials of MS drugs.¹⁷

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

Christine
Boutwell, MD,
compensated by
Teva Neuroscience, Inc.

Safety & Side Effects

MS Quizzes

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^®.

Liver problems, including liver failure, can occur with COPAXONE^®. Call your healthcare provider right away if you have symptoms, such as nausea, loss of appetite, tiredness, dark colored urine and pale stools, yellowing of your skin or the white part of your eye, bleeding more easily than normal, confusion, or sleepiness.

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 side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-10881-800-FDA-1088.

Please read the Patient Information in the full Prescribing Information.

References:

COPAXONE^® (glatiramer acetate injection) Current Prescribing Information Parsippany, NJ. Teva Neuroscience, Inc.
Definition of MS. National Multiple Sclerosis Society (NMSS). Accessed November 18, 2018. https://www.nationalmssociety.org/What-is-MS/Definition-ofMS
What is an immune-mediated disease? National Multiple Sclerosis Society (NMSS). Accessed November 18, 2018. https://www.nationalmssociety.org/What-is-MS/Definition-of-MS/Immune-mediated-disease
Bennett JL, Stüve 0. Update on inflammation, neurodegeneration, and immunoregulation in multiple sclerosis: therapeutic implications. Clin Neuropharmacol. 2009;32(3):121-132. doi:10.1097/WNF.0b013e3181880359
Balashov K. Drugs in development for multiple sclerosis. Practical Neurology. February 2020. Accessed July 13, 2021. https://practicalneurology.com/articles/2020-feb/drugs-in-development-for-multiple-sclerosis
Goronzy JJ, Weyand CM. Understanding immune senescence to improve vaccine responses. Nat Immunol. 2013;14(5):428-436. doi:10.1038/ni.2588
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. doi.10.1002/ana.23938
Managing relapses. National Multiple Sclerosis Society (NMSS). Accessed November 18, 2018. https://www.nationalmssociety.org/Treating-MS/Managing-Relapses
Magnetic resonance imaging (MRI). National Multiple Sclerosis Society (NMSS). Accessed November 18, 2018. https://www.nationalmssociety.org/Symptoms-Diagnosis/Diagnosing-Tools/MRI
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. doi:10.1056/NEJM198708133170703
Johnson KP, Brooks BR, Cohen JA, et al; the Copolymer 1 Multiple Sclerosis Study Group. 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. doi:10.1212/wnl.45.71268
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. https://doi.org/10.1002.ana.64
Comi G, Martinelli V, Rodegher M, et al; PreCISe Study Group. 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. doi.10.1016/50140-6736(09)61259-9
US Department of Health and Human Services. Supplement approval. Accessed November 18, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020622s057ltr.pdf
US Department of Health and Human Services. Supplement approval. Accessed November 18, 2018. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020622Orig1s089ltr.pdf
Ford CC, Cohen JA, Goodman AD, et al. Early versus delayed treatment with glatiramer acetate: Analysis of up to 27 years of continuous follow-up in a US open-label extension study. Mult Scler. 2022;28(11):1729-1743. doi:10.1177/13524585221094239
Expanded Disability Status Scale (EDSS). Multiple Sclerosis Society (MS Society UK). Accessed August 9, 2023. https://www.mssociety.org.uk/about-ms/treatments-and-therapies/getting-treatment-for-ms/expanded-disability-status-scale

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

HOW DOES COPAXONE® WORK?

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

A 27-year study of the active ingredient in COPAXONE® found long-term safety results16

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

HOW DOES COPAXONE^® WORK?

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

A 27-year study of the active ingredient in COPAXONE® found long-term safety results¹⁶

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