||Chemical Name |
(U.S. and Canada)
|Glatiramer Acetate |
[formerly called Copolymer-1]
Primary Usage in MS
|This medication is taken by injection.|
Glatiramer acetate is a synthetic compound made up of four amino acids (the building blocks of proteins) that are found in myelin. This drug is thought to stimulate T cells in the body’s immune system to change from harmful, pro-inflammatory agents to beneficial, anti-inflammatory agents that work to reduce inflammation at lesion sites. In a two-year randomized, double-blind, controlled trial involving 251 ambulatory patients with relapsing-remitting MS, those taking the drug had a 29% reduction in annual relapse rate compared to control subjects who were given a placebo. Subsequent studies have confirmed the drug’s effectiveness in reducing the number and severity of exacerbations (also called attacks, relapses, or flares) and have also demonstrated its ability to reduce the number of new, gadolinium-enhancing brain lesions on MRI.
Approval by the U.S. Food and Drug Administration (FDA)
Glatiramer acetate is approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency of relapses in patients with relapsing-remitting MS.
Glatiramer acetate is injected subcutaneously (between the fat layer just under the skin and the muscles beneath) once a day. The physician or nurse will instruct you in correct injection procedures, using a specially designed set of training materials. Do not attempt to inject yourself until you are sure that you understand the procedures.
Glatiramer acetate should be kept refrigerated at all times. If refrigeration is not available, the drug may be safely stored at room temperature for up to seven days.
Glatiramer acetate is light-sensitive; protect it from light when not injecting.
Use each pre-filled syringe for only one injection. Dispose of the syringes as directed by your physician and keep them out of the reach of children.
Because injection-site reactions (swelling, redness, discoloration, or pain) are relatively common, it is recommended that the sites be rotated according to a schedule provided for you by your physician. Do not use any one site more than once per week.
Do not use a pre-filled syringe that appears cloudy or contains particles.
Do not change the dose or dosing schedule of this medication without consulting your physician.
Glatiramer acetate is not recommended for use during pregnancy. Women who wish to become pregnant should discuss this medication, and all others they are taking, with their physician. If you become pregnant while on the medication, inform your physician. Glatiramer acetate is a Pregnancy Category B medication, meaning that although no adverse effects have been found in animal studies, no adequate, well-controlled studies have been done in pregnant women to demonstrate its safety in humans.
It is not known whether glatiramer acetate passes into the breast milk. Nursing women should discuss the use of this medication with their physician.
Possible Side Effects
Side effects that generally resolve on their own and do not require medical attention unless they continue for several weeks or are bothersome: injection-site reactions (e.g., swelling, the development of a hardened lump, redness, tenderness, increased warmth of the skin, itching at the site of the injection); runny nose; tremor*; unusual tiredness or weakness*; weight gain.
Unusual side effects that should be discussed as soon as possible with your doctor: Hives (an itchy, blotchy swelling of the skin) or severe pain at the injection site.
Possible immediate post-injection reaction: Approximately 13% of individuals using Copaxone will experience, at one time or another, a transient (very temporary) reaction immediately after injecting glatiramer acetate. This reaction, which usually occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing. During the clinical trials, these reactions occurred very rarely, usually within minutes of an injection. They lasted approximately 15 minutes and resolved without further problem.
*Since it may be difficult to distinguish between certain common symptoms of MS and some side effects of glatiramer acetate, be sure to consult your health care professional if an abrupt change of this type occurs.
COPAXONE SUPPORT PROGRAM