EXARANE

What it is

Exarane is a biosimilar medicine to Clexane containing enoxaparin sodium. The evidence for comparability supports the use of Exarane for the listed indications. Exarane is available as ready-to-use prefilled syringes in strengths of 20 mg, 40 mg, 60 mg, 80 mg and 100 mg, with Exarane Forte available in 120 mg and 150 mg strengths.

Approved indications

— Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery. — Prophylaxis of venous thromboembolism in medical patients bedridden due to acute illness. — Prevention of thrombosis in extra-corporeal circulation during haemodialysis. — Treatment of established deep vein thrombosis. — Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with aspirin. — Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

Dosing overview

Prophylaxis dosing is tailored according to patient risk: high risk patients receive 40 mg subcutaneously once daily, and moderate risk patients receive 20 mg subcutaneously once daily. For prophylaxis in medical patients, the recommended dose is 40 mg once daily by subcutaneous injection for a minimum of 6 days, continuing for a maximum of 14 days. For treatment of established deep vein thrombosis, the recommended dosage is 1.5 mg/kg body weight once daily or 1 mg/kg body weight twice daily subcutaneously. For treatment of unstable angina and non-Q-wave myocardial infarction, the recommended dose is 1 mg/kg every 12 hours by subcutaneous injection, administered concurrently with oral aspirin. For acute STEMI, the recommended dose is a single intravenous bolus of 30 mg plus a 1 mg/kg subcutaneous dose, followed by 1 mg/kg administered subcutaneously every 12 hours (maximum 100 mg for each of the first two subcutaneous doses only). For haemodialysis, a dose of 1 mg/kg is injected into the arterial line at the start of the session, usually sufficient for a 4-hour haemodialysis session.

Key safety warnings

The timing of the first dose may need to be modified if spinal or epidural anaesthesia is to be performed. Under normal conditions of use, Exarane does not modify global clotting tests and therefore there is no need to perform these tests in order to monitor therapy. A dosage adjustment is required for patients with severe renal impairment (creatinine clearance less than 30 mL/min).

PBS listing

Exarane Forte 150 mg (15,000 IU anti-Xa) in 1 mL pre-filled syringe and 120 mg (12,000 IU anti-Xa) in 0.8 mL pre-filled syringe are listed on the PBS with restriction, at ex-manufacturer prices of A$90.03 and A$72.02 respectively.

Regulatory history

Exarane and Exarane Forte were approved by the TGA on 27 June 2023 for the prevention and treatment of various thrombo-embolic disorders on the basis of demonstrated biosimilarity to the reference product Clexane. The TGA's evaluation found Exarane to be similar to Clexane across quality, nonclinical, and clinical pharmacodynamic parameters, with extensive characterisation studies, comparative in vitro and in vivo nonclinical studies, and a Phase I clinical study demonstrating bioequivalence and comparable immunogenicity. Initial ARTG registrations were listed on 28 July 2023 for seven strengths, with additional registrations for variants with safety lock systems listed on 13 May 2024.