CLEXANE

What it is

Clexane is a low molecular weight heparin with an approximate molecular weight of 4500 daltons. It is available as enoxaparin sodium in ready-to-use prefilled syringes containing 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg or 150 mg per injection. Clexane is characterised by a higher ratio of anti-Xa to anti-IIa activity and acts on the coagulation pathway through binding to antithrombin III, with antithrombotic activity related to inhibition of thrombin generation and inhibition of Factor Xa and Thrombin.

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

For prophylaxis in high-risk patients, the recommended dosage is 40 mg administered subcutaneously once daily. For moderate-risk patients, the recommended dosage is 20 mg subcutaneously once daily. For prophylaxis of venous thromboembolism 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 deep vein thrombosis, the recommended dosage is 1.5 mg per kilogram body weight once daily or 1 mg per kilogram body weight twice daily subcutaneously. For treatment of unstable angina and non-Q-wave myocardial infarction, the recommended dose is 1 mg per kilogram every 12 hours by subcutaneous injection, administered concurrently with oral aspirin. For treatment of acute STEMI administered with a fibrinolytic agent, the recommended dose is a single intravenous bolus of 30 mg plus a 1 mg per kilogram subcutaneous dose, followed by 1 mg per kilogram administered subcutaneously every 12 hours (maximum 100 mg for each of the first two subcutaneous doses only).

Key safety warnings

Clexane should be used with extreme caution in conditions with increased risk of haemorrhage such as bacterial endocarditis, bleeding disorders, active ulcerative gastrointestinal disease or haemorrhagic stroke. Major haemorrhages including retroperitoneal and intracranial bleeding have been reported, and some of these cases have been fatal. Rare cases of neuraxial haematomas have been reported with concurrent use of Clexane and spinal/epidural anaesthesia resulting in long-term or permanent paralysis. These events are rare with dosage regimens of 40 mg once daily or lower, but the risk is greater with higher dosage regimens and concomitant use of additional drugs affecting haemostasis such as non-steroidal anti-inflammatory drugs. Thrombocytopenia can occur with Clexane administration. Moderate thrombocytopenia occurred at 1.3% in patients given Clexane and severe thrombocytopenia at 0.1%. Thrombocytopenia of any degree should be monitored closely, and if the platelet count falls below 100,000 per mm³, Clexane should be discontinued. In patients with renal impairment, there is an increase in exposure to Clexane which increases the risk of bleeding. Dosage adjustment is recommended for patients with severe renal impairment (creatinine clearance less than 30 mL per minute).

Contraindications

Allergy to Clexane, heparin or its derivatives including other low molecular weight heparins is a contraindication. Acute bacterial endocarditis is a contraindication. Conditions with a high risk of uncontrolled haemorrhage including major bleeding disorders, focal lesions, haemorrhagic stroke and active ulcerative conditions showing a tendency to haemorrhage are contraindications. History of immune mediated heparin-induced thrombocytopenia within the past 100 days or in the presence of circulating antibodies is a contraindication.

PBS listing

Clexane is listed on the PBS in strengths of 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 120 mg and 150 mg per prefilled syringe. The 20 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths each have 2 PBS items, whilst the 120 mg and 150 mg strengths each have 1 PBS item. All strengths are restricted. The ex-manufacturer prices are: 20 mg A$23.34, 40 mg A$26.09, 60 mg A$45.16, 80 mg A$48.01, 100 mg A$63.67, 120 mg A$72.02 and 150 mg A$90.03.

Regulatory history

Clexane was first registered on the ARTG on 12 February 1993 with strengths of 20 mg and 40 mg. Additional strengths of 60 mg, 80 mg and 100 mg were added to the ARTG on 1 November 1996. Clexane Forte strengths of 120 mg and 150 mg were registered on 9 May 2000. Variants with automatic safety lock systems were registered on 10 July 2014. Variants with Eris automatic safety lock systems were registered commencing 23 December 2025. In July 2019, the PBAC recommended unrestricted benefit listing for the 120 mg and 150 mg strengths on a cost minimisation basis. In July 2020, a new listing for prevention and treatment of deep vein thrombosis and haemodialysis was recommended. Subsequent PBAC recommendations in July 2022 and July 2023 extended the recommendation period for multiple thromboembolic indications.