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(glatiramer acetate) Solution for Subcutaneous Injection
COPAXONE is the brand name for glatiramer acetate (formerly known as copolymer-1). Glatiramer acetate, the active ingredient of COPAXONE (glatiramer acetate) , consists of the acetate salts of synthetic polypeptides, containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine with an average molar fraction of 0.141, 0.427, 0.095, and 0.338, respectively. The average molecular weight of glatiramer acetate is 5,000 – 9,000 daltons. Glatiramer acetate is identified by specific antibodies.
Chemically, glatiramer acetate is designated L-glutamic acid polymer with L-alanine, L-lysine and L-tyrosine, acetate (salt). Its structural formula is:
(Glu, Ala, Lys, Tyr)x•xCH3COOH
CAS - 147245-92-9
COPAXONE (glatiramer acetate) is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution for subcutaneous injection. Each 1 mL of solution contains 20 mg of glatiramer acetate and 40 mg of mannitol. The pH range of the solution is approximately 5.5 to 7.0. The biological activity of COPAXONE (glatiramer acetate) is determined by its ability to block the induction of experimental autoimmune encephalomyelitis (EAE) in mice.
What are the possible side effects of glatiramer (Copaxone)?
Some people receiving a glatiramer injection have had a severe reaction. Tell your caregiver right away if you feel anxious, warm, itchy, tingly, or have a pounding heartbeat, tightness in your throat, or trouble breathing during the injection. This type of reaction may occur even after you have been using glatiramer for several months.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any of these serious side...
What are the precautions when taking glatiramer acetate (Copaxone)?
Before using glatiramer, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as mannitol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease (e.g., chest pain, heart attack).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is not known if this drug passes into breast milk. Consult your doctor before...
Last reviewed on RxList: 4/15/2009
This monograph has been modified to include the generic and brand name in many instances.
Additional Copaxone Information
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