GLATIRAMER ACETATE-TEVA

What it is

Glatiramer acetate-Teva is a solution for injection containing 40 mg of glatiramer acetate per millilitre. It is supplied as a clear, colourless solution for injection in a pre-filled syringe. The active ingredient is the acetate salt of synthetic polypeptides containing four naturally occurring amino acids: L-glutamic acid, L-alanine, L-tyrosine and L-lysine.

Approved indications

— Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis. — Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple sclerosis, if alternative diagnoses have been excluded.

Dosing overview

The recommended dosage in adults is one subcutaneous injection of 1 mL (40 mg) administered three times a week and at least 48 hours apart. The only recommended route of administration is by the subcutaneous route; glatiramer acetate-Teva should not be administered by the intravenous or intramuscular routes.

Key safety warnings

Immediate post-injection reactions may occur in approximately 2% of patients given glatiramer acetate-Teva 40 mg/mL, with symptoms including flushing, chest pain, palpitations, anxiety, dyspnoea, constriction of the throat and urticaria. These symptoms are generally transient and self-limited and do not require specific treatment. Transient chest pain has been reported in approximately 2% of patients given glatiramer acetate 40 mg/mL. The pain is usually transient, often not associated with other symptoms, and appears to have no clinical sequelae. Anaphylactic reactions may occur shortly following administration of glatiramer acetate-Teva, even months or years after initiation of treatment, and cases with fatal outcomes have been reported. At injection sites, localised lipoatrophy and, rarely, injection site skin necrosis may occur. Skin necrosis has only been observed in the post-marketing setting. Localised lipoatrophy may occur at various times after treatment onset (sometimes after several months) and is thought to be permanent. Rare cases of severe liver injury, including liver failure, hepatitis with jaundice, and extremely rare cases of fulminant hepatitis leading to liver transplant, have been reported during postmarketing experience. Hepatic adverse events have occurred from days to years after initiating treatment with glatiramer acetate.

Contraindications

Glatiramer acetate-Teva is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

Regulatory history

Glatiramer acetate-Teva 40 mg/1 mL solution for injection in pre-filled syringe was first registered on the Australian Register of Therapeutic Goods on 14 September 2021.