Glatiramer Acetate

What it is and how it works

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.

Indications

Glatiramer acetate injection is 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. Glatiramer acetate injection is 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 .

Dosage and administration (summary)

For subcutaneous injection only; doses are not interchangeable Glatiramer acetate injection 20 mg/mL per day Glatiramer acetate injection 40 mg/mL three times per week Before use, allow the solution to warm to room temperature Recommended Dose Glatiramer acetate injection is for subcutaneous use only . Do not administer intravenously. The dosing schedule depends on the product strength that is selected.

Contraindications

Glatiramer acetate injection is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol. Reactions have included anaphylaxis . Known hypersensitivity to glatiramer acetate or mannitol

Warnings and precautions

Immediate Post-Injection Reaction (flushing, chest pain, palpitations, tachycardia, anxiety, dyspnea, throat constriction, and/or urticaria), may occur within seconds to minutes after injection and are generally transient and self-limiting Chest pain, usually transient Lipoatrophy and skin necrosis may occur.

Pregnancy

Pregnancy Risk Summary Available data from pharmacovigilance and published observational studies over decades of use with glatiramer acetate during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes (see Data).

Storage and supply

Glatiramer acetate injection is a clear, colorless to slightly yellow, sterile, nonpyrogenic solution supplied as: 20 mg per mL in a single-dose, prefilled syringe with a white plunger, in individual blister packages supplied in 30-count cartons (NDC 70710-1548-9).

Source: Glatiramer Acetate (Glatiramer Acetate) — US FDA prescribing information, 2026-08-19, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.