COPAXONE

What it is

COPAXONE is glatiramer acetate 40 mg/mL, a solution for injection in a pre-filled syringe. Glatiramer acetate 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 COPAXONE 40 mg administered three times a week and at least 48 hours apart. Sites for self-injection include arms, abdomen, hips and thighs, and a different site should be used each day to reduce the likelihood of local irritation or pain.

Key safety warnings

Immediate post-injection reactions may occur, characterised by symptoms including flushing, chest pain, palpitations, anxiety, dyspnoea, constriction of the throat, and urticaria. In clinical trials of glatiramer acetate 40 mg/mL, approximately 2% of patients experienced such symptoms. Symptoms are generally transient and self-limited and do not require specific treatment, and typically onset several months after initiating treatment. Anaphylactic reactions may occur shortly following administration of COPAXONE, even months or years after initiation of treatment, and cases with fatal outcomes have been reported. All patients and caregivers should be informed about the signs and symptoms of anaphylactic reactions and should seek immediate emergency medical care if such symptoms occur. Localised lipoatrophy and, rarely, injection site skin necrosis may occur at injection sites. Skin necrosis has only been observed in the post-marketing setting, and localised lipoatrophy may occur at various times after treatment onset 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 post-marketing experience with glatiramer acetate, with hepatic adverse events occurring from days to years after initiating treatment. Prior to initiating treatment, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained within six months for all patients, and patients should be monitored during treatment for signs of hepatic injury.

Contraindications

COPAXONE is contraindicated in patients with known hypersensitivity to glatiramer acetate or mannitol.

PBS listing

Two presentations are PBS listed with streamlined restriction: the pre-filled syringe containing glatiramer acetate 40 mg in 1 mL at an ex-manufacturer price of A$491.66, and the pre-filled pen containing glatiramer acetate 40 mg in 1 mL at an ex-manufacturer price of A$522.96.

Regulatory history

COPAXONE pre-filled syringe (ARTG 218615) was first listed on 25 February 2015, and COPAXONE PEN (ARTG 316728) was first listed on 17 April 2019.