Glatiramer acetate 40mg/1ml solution for injection pre-filled syringes

Glatiramer acetate is a mix of synthetic polypeptides that includes four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine, and L-lysine. This drug is indicated for the treatment of relapsing multiple sclerosis (MS) due to its ability to modify immune processes involved in the pathogenesis of this disease. Intact and large fragments of glatiramer acetate are recognized by glatiramer acetate-reactive antibodies. In vitro and in vivo studies suggest that upon its administration, glatiramer acetate-specific suppressor T-cells are induced and activated in the periphery. [L41940] A fraction of intact or partially hydrolyzed glatiramer acetate enters lymphatic circulation and is able to reach the lymph nodes.[L41940] Compared to placebo and IFNb-1a, patients with relapsing-remitting MS receiving 20 mg/mL of glatiramer acetate once a day had significantly lower annualized relapse rates. Similar outcomes were observed in MS patients taking 40 mg/mL of glatiramer acetate three times a week.[A248865]

Some of the patients treated with glatiramer acetate (approximately 16%) have developed immediate post-injection reactions. Most of these cases are transient and do not require treatment, but there have been reports of patients requiring emergency medical care.[L41940] Patients taking glatiramer acetate may also experience chest pain, injection site side effects such as localized lipoatrophy and skin necrosis, and hepatic injury.[L41940] Since glatiramer acetate modifies immune response, it may interfere with immune function.[L41940]