GLATIRA

What it is

GLATIRA is glatiramer acetate supplied as a solution for injection in a pre-filled syringe, containing 40 mg of glatiramer acetate. 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. GLATIRA is a clear, colourless solution for injection in a pre-filled syringe.

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 GLATIRA 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 for injection should be used each day in order to reduce the likelihood of local irritation or pain. Before injecting, the solution should be removed from refrigerated storage and left at room temperature for about 20 minutes to warm up.

Key safety warnings

Immediate post-injection reactions have been reported in approximately 2% of patients given glatiramer acetate 40 mg/mL in placebo-controlled studies, with symptoms including flushing, chest pain, palpitations, anxiety, dyspnoea, constriction of the throat and urticaria that are generally transient and self-limited. Anaphylactic reactions may occur shortly following administration of GLATIRA, 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, and localised lipoatrophy may occur at various times after treatment onset and is thought to be permanent. To assist in possibly minimising these events, the patient should be advised to follow proper injection technique and to rotate injection sites with each injection. 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 with glatiramer acetate during post-marketing experience, with hepatic adverse events occurring from days to years after initiating treatment. Prior to initiating treatment with GLATIRA, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained for all patients, and patients should be monitored during treatment for signs of hepatic injury; patients should be advised to immediately report any signs or symptoms of hepatotoxicity such as jaundice, dark urine, abdominal pain, nausea, vomiting, loss of appetite, weight loss and unusual fatigue.

Contraindications

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

PBS listing

GLATIRA 40 mg/mL pre-filled syringe was recommended by PBAC in March 2021 for treatment of Multiple Sclerosis. Two strengths are registered on the ARTG: GLATIRA glatiramer acetate 20 mg/1mL solution for injection prefilled syringe and GLATIRA glatiramer acetate 40 mg/1mL solution for injection prefilled syringe.

Regulatory history

GLATIRA glatiramer acetate 40 mg/1mL solution for injection prefilled syringe was first listed on the ARTG on 12 November 2020. PBAC recommended GLATIRA for Multiple Sclerosis in March 2021.