Copaxone (glatiramer acetate)
Also marketed as Glatopa. An approved treatment for Multiple Sclerosis.
The same compound appears under different names depending on the context. Here is how to identify Glatiramer acetate wherever you encounter it, plus the key facts at a glance.
- Generic name
- Glatiramer acetate
- Brand names
- Copaxone, Glatopa
- Development code
- Copolymer 1
- Drug class
- Immunomodulator
- Manufacturer
- Teva Pharmaceuticals
- How it's taken
- Available as subcutaneous injection in two regimens: 20 mg daily or 40 mg 3 times per week.
One of the earliest disease-modifying therapies for MS and still widely used. Copaxone is a synthetic protein mixture given by injection that modulates the immune system to reduce MS relapses. It is approved for adults with relapsing forms of MS; it has not been shown to be safe and effective in people under 18.
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Where Glatiramer acetate fits
One of the earliest disease-modifying therapies for relapsing MS. Now often a first-line option due to its well-established long-term safety profile and generic availability.
How Glatiramer acetate works
Glatiramer acetate is a mixture of four amino acids that resembles myelin basic protein, one of the targets the immune system attacks in MS. By introducing this decoy, it redirects immune cells away from attacking the actual myelin coating on nerves. It also promotes the development of regulatory T cells that actively suppress the harmful immune response in the brain.
Mechanism: Immunomodulator composed of a synthetic polypeptide mixture that shifts immune response from harmful to protective in MS
Side effects and safety
Copaxone carries a boxed warning for anaphylaxis: life-threatening and fatal allergic reactions have been reported, and they can happen at any time, from the first dose to years after starting. Anyone who has anaphylaxis must stop the drug. Injection site reactions are very common (redness, pain, swelling). An immediate post-injection reaction (flushing, chest pain, palpitations, anxiety, shortness of breath, throat tightness or hives) can occur within seconds to minutes and is usually brief, but its symptoms can overlap with anaphylaxis, so seek emergency care if symptoms are severe or do not go away. Other label warnings include chest pain, lipoatrophy and skin necrosis at injection sites, and liver injury, which can be severe and has included liver failure. The label also warns that it can change how the immune system responds, and that using an autoinjector not made for your specific glatiramer product can cause missed or partial doses.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Glatiramer acetate
Available as subcutaneous injection in two regimens: 20 mg daily or 40 mg 3 times per week. Self-administered at home using pre-filled syringes or autoinjectors. Rotate injection sites to minimize skin reactions.
Availability and cost
Generic versions may be available at a lower cost. Ask your pharmacist.
Injectable immunomodulator available in generic form with multiple approved versions. One of the earliest MS therapies, with well-established manufacturing processes.
Help paying for Copaxone
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
Commercially insured patients may pay as little as $0 for Copaxone; no financial qualifications. Medicare, Medicaid, TRICARE, VA and other government plans excluded.
For: private insurance · source
Good to know: Covers brand Copaxone only. Medicare patients are pointed to independent nonprofits. Generic glatiramer is also available.
- From a charity · TotalAssist (formerly PAN Foundation)Multiple Sclerosis fundOpen
Pays for: Out-of-pocket costs for approved medications, up to $8,000 per year. Requires Medicare, Medicaid or TRICARE.
- From a charity · The Assistance FundMultiple Sclerosis fundWaitlist
Pays for: Copays, coinsurance, deductibles and other health-related expenses.
The foundation says: “WAITLIST — Accepting Waitlist Patients. TAF is currently accepting requests to join the enrollment waitlist for this program. Waitlists a…”
Clinical trial results
The original pivotal trial showed a 29% reduction in relapse rate. The GALA trial showed the 40 mg three-times-weekly dose reduced relapses compared with placebo, which led to its 2014 approval. Over 25 years of real-world safety data.
Development history
Approved by FDA in December 1996. One of the first MS disease-modifying therapies alongside interferon beta. Has an extensive long-term safety record. Generic version (Glatopa, made by Sandoz) approved in 2015. Remains widely prescribed due to safety profile, especially for patients planning pregnancy.
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Common questions about Glatiramer acetate
▸What is Glatiramer acetate (Copaxone)?
One of the earliest disease-modifying therapies for MS and still widely used. Copaxone is a synthetic protein mixture given by injection that modulates the immune system to reduce MS relapses. It is approved for adults with relapsing forms of MS; it has not been shown to be safe and effective in people under 18.
▸How does Glatiramer acetate work?
Glatiramer acetate is a mixture of four amino acids that resembles myelin basic protein, one of the targets the immune system attacks in MS. By introducing this decoy, it redirects immune cells away from attacking the actual myelin coating on nerves. It also promotes the development of regulatory T cells that actively suppress the harmful immune response in the brain.
▸What are the side effects of Glatiramer acetate?
Copaxone carries a boxed warning for anaphylaxis: life-threatening and fatal allergic reactions have been reported, and they can happen at any time, from the first dose to years after starting. Anyone who has anaphylaxis must stop the drug. Injection site reactions are very common (redness, pain, swelling). An immediate post-injection reaction (flushing, chest pain, palpitations, anxiety, shortness of breath, throat tightness or hives) can occur within seconds to minutes and is usually brief, but its symptoms can overlap with anaphylaxis, so seek emergency care if symptoms are severe or do not go away. Other label warnings include chest pain, lipoatrophy and skin necrosis at injection sites, and liver injury, which can be severe and has included liver failure. The label also warns that it can change how the immune system responds, and that using an autoinjector not made for your specific glatiramer product can cause missed or partial doses.
▸How is Glatiramer acetate taken?
Available as subcutaneous injection in two regimens: 20 mg daily or 40 mg 3 times per week. Self-administered at home using pre-filled syringes or autoinjectors. Rotate injection sites to minimize skin reactions.
▸Is Glatiramer acetate FDA approved?
Yes, Glatiramer acetate (Copaxone) is FDA approved (1996) for the treatment of Multiple Sclerosis.
▸Is glatiramer acetate safe during pregnancy?
Glatiramer acetate is one of the MS therapies most commonly considered for use around the time of pregnancy. While no MS drug is formally FDA-approved for use during pregnancy, glatiramer acetate has the longest safety track record and the most reassuring pregnancy data. Many neurologists allow patients to continue it during pregnancy or recommend it for patients who are planning to become pregnant. The decision should be made in close consultation with both your neurologist and obstetrician.
▸What is the post-injection reaction with Copaxone?
A small percentage of patients experience an immediate post-injection reaction that can include flushing, chest tightness, heart palpitations, anxiety, and shortness of breath. This reaction typically begins within seconds to minutes after an injection and usually goes away on its own. On its own it does not require stopping the medication. However, the label warns that its symptoms can overlap with anaphylaxis, a life-threatening allergic reaction that has been reported with glatiramer acetate at any point in treatment, including years after starting. Seek emergency care right away for trouble breathing, swelling of the face, lips or throat, widespread hives, or symptoms that are severe or do not improve.
▸How does glatiramer acetate compare to more potent MS therapies?
Glatiramer acetate reduces relapse rate by about 29%, which is more modest than higher-efficacy options like ocrelizumab, natalizumab, or ofatumumab. However, it has one of the best long-term safety profiles of any MS therapy, with over 25 years of clinical experience and no known link to PML, although the label notes it can change how the immune system responds and this has not been fully studied. It is often chosen for patients with mild to moderate disease, those planning pregnancy, or patients who prioritize safety over maximum efficacy.
▸Is there a generic version of Copaxone?
Yes. Glatopa, a generic version of Copaxone made by Sandoz, was approved by the FDA in 2015. It is available in both the 20 mg daily and 40 mg three-times-weekly formulations. Generic glatiramer acetate is less expensive than branded Copaxone and is considered therapeutically equivalent.
▸How do I rotate injection sites?
Glatiramer acetate should be injected subcutaneously (under the skin) in different locations each time to minimize skin reactions like lipoatrophy (loss of fat tissue under the skin) or nodule formation. Recommended sites include the upper arms, thighs, hips, and abdomen. Use a systematic rotation pattern, and avoid injecting into the same site within a 7-day period. Your nurse or MS care team can provide an injection site map and training.