What is the dosage regimen for glatiramer acetate (Copaxone) in the treatment of relapsing-remitting multiple sclerosis (MS) (RRMS)?

Updated: Oct 08, 2019
  • Author: Christopher Luzzio, MD; Chief Editor: Jasvinder Chawla, MD, MBA  more...
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Answer

In January 2014, a higher dose and lower-frequency dosage regimen of glatiramer was approved. The 20-mg/mL SC injection is specific for the original once-daily regimen, whereas the new 40-mg/mL SC injection is specific for the 3-times-per-week dosage regimen. Approval for the new regimen was based on the phase 3 Glatiramer Acetate Low-Frequency Administration (GALA) study. The GALA trial included 1,404 patients and showed that treatment with 40 mg SC 3 times/wk reduced mean annualized relapse rates by 34% compared with placebo (0.331 vs 0.505; P< .0001) at 12 months. [95]


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