This medication is taken by injection.
Glatiramer acetate is a synthetic protein that simulates myelin basic protein, a component of the myelin that insulates nerve fibers in the brain and spinal cord. This drug seems to block myelin-damaging T-cells through a mechanism that is not completely understood.
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. It is also approved for use in individuals who have experienced a first clinical episode (clinically-isolated syndrome) and have MRI features that are consistent with multiple sclerosis.
In January, 2014, the FDA approved a new 40 mg/mL dose of this medication, injected three times per week, which is double the standard 20 mg/mL dose that is injected daily. The approval was based on benefits and safety demonstrated in a one-year phase III trial comparing the higher, less-frequent dose of the medication with placebo. The standard dosing option continues to be available.
Click here to read the FDA Prescribing Information for healthcare professionals.
To read the Patient Information, go to Prescribing Information and scroll down to p. 6.
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