General Information

Copaxone (glatiramer acetate injection) is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS.

Copaxone is specifically indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

Copaxone is is for subcutaneous use only. Do not administer intravenously. The dosing schedule depends on the product strength that is selected. The recommended doses are:

• Copaxone 20 mg per mL: administer once per day
• Copaxone 40 mg per mL: administer three times per week and at least 48 hours apart

Mechanism Of Action

The mechanism(s) by which glatiramer acetate exerts its effects in patients with MS are not fully understood. However, glatiramer acetate is thought to act by modifying immune processes that are believed to be responsible for the pathogenesis of MS. This hypothesis is supported by findings of studies that have been carried out to explore the pathogenesis of experimental autoimmune encephalomyelitis, a condition induced in animals through immunization against central nervous system derived material containing myelin and often used as an experimental animal model of MS. Studies in animals and in vitro systems suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. Because glatiramer acetate can modify immune functions, concerns exist about its potential to alter naturally-occurring immune responses. There is no evidence that glatiramer acetate does this, but this has not been systematically evaluated.

Side Effects

Adverse effects associated with the use of Copaxone may include, but are not limited to, the following:

• injection site reactions
• flushing
• chest pain
• weakness
• infection
• pain
• nausea
• joint pain
• anxiety
• muscle stiffness

Clinical Trial Results

In a two-year multicenter, randomized, double blind, placebo-controlled trial of 251 patients, copaxone (glatiramer acetate for injection) was shown to reduce relapses by an average of 29 percent when compared with placebo.