Copaxone (glatiramer acetate)

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Copaxone (glatiramer acetate) is an injectable disease-modifying treatment approved by the FDA for reducing the frequency of exacerbations or relapses in people with relapse-remitting MS (RRMS), made by TEVA Neuroscience. Copaxone is also approved for delaying a second exacerbation in people who have been diagnosed with clinically isolated syndrome (CIS).

 

How does Copaxone work?

Copaxone is a synthetic protein that simulates a component of myelin, the substance that acts as a protective covering on nerve fibers. The CNS damage that occurs in MS is a result of demyelination, a process during which inflammation damages myelin. Although the exact mechanism by which Copaxone works is unknown, it appears that Copaxone blocks the activity of T cells, a type of white blood cell involved in the immune response that causes nerve damage in MS.

 

How is Copaxone taken?

Copaxone comes in a prefilled syringe and is given by subcutaneous (under the skin) injection once a day. The recommended daily dose of Copaxone is 20 mg. To keep track of your schedule for taking Copaxone, you should plan your injection at the same time every day. You’ll get your first injection of Copaxone in your doctor’s office. Your doctor will give you complete instructions about how to take Copaxone and will help you or a friend or family member learn to give the injection, so that you can take Copaxone on your own at home. The instructions for taking Copaxone illustrate 7 different areas on your body where the medicine can be injected. To reduce injection site reactions (swelling, redness, pain, or discoloration), choose a different place for the injection every day of the week.

 

What if I miss a dose of Copaxone?

If you miss a dose of Copaxone, take the injection as soon as you remember, unless it is close to the time for your next injection. DO NOT take a double injection of Copaxone to make up for a missed dose. Call your doctor if you have missed your regularly scheduled injection and have any questions about when you should take your next injection.

 

How should Copaxone be stored?

Copaxone pre-filled syringes should be refrigerated. If this is not possible, the syringes can be stored at room temperature (not above 77ºF) for 1 month. Copaxone must be stored in a place away from the light and should never be frozen.

 

Are there people who should not take Copaxone?

Copaxone should not be used by persons who are allergic to the medication. If you have an allergic reaction to Copaxone, with symptoms such as hives, skin rash with irritation, dizziness, sweating, chest pain, trouble breathing, or severe pain at the injection site, do not give yourself another injection of Copaxone and call your doctor immediately.

It is not known if Copaxone can be used safely in pregnant women. So, if you’re planning to get pregnant, talk to your doctor about possible risks and benefits of using Copaxone during pregnancy. Talk to your doctor about whether you should breast feed while taking Copaxone, as it is not known whether Copaxone is passed through breast milk or if it can harm your baby.

 

What evidence do we have that Copaxone works?

Evidence of the effectiveness of Copaxone in RRMS comes from three placebo-controlled studies. In 2 studies, Copaxone was found to lower the frequency of relapses or exacerbations in persons with RRMS when compared with placebo. Another study found that Copaxone resulted in a decreased number and volume of brain lesions as revealed by magnetic resonance imaging (MRI).

In a separate study, Copaxone was tested in people diagnosed with clinically isolated syndrome (CIS). People in this study with CIS who received Copaxone experienced a delay in the time it took to have a second exacerbation (which typically leads to a confirmed diagnosis of MS).

 

Is there a generic version of Copaxone?

At this time, there is no generic version of Copaxone.

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