RELABAN

What it is

RELABAN is a rivaroxaban product registered with the ARTG, available as capsules in 15 mg and 20 mg strengths.

Approved indications RELABAN is indicated for:

— Prevention of venous thromboembolism in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement, treatment for up to 5 weeks; elective total knee replacement, treatment for up to 2 weeks). — Prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and at least one additional risk factor for stroke. — Treatment of deep vein thrombosis and pulmonary embolism and for the prevention of recurrent deep vein thrombosis and pulmonary embolism. — The prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease and/or peripheral artery disease, in combination with aspirin.

Dosing overview

For venous thromboembolism prevention in major orthopaedic surgery of the lower limbs, the recommended dose of RELABAN is 10 mg once daily, with the initial dose taken 6 to 10 hours after surgery provided that haemostasis has been established. For stroke prevention in atrial fibrillation, the recommended dose is 20 mg once daily, or 15 mg once daily for patients with severe and moderate renal impairment (Creatinine clearance 15 to 49 mL/min). For treatment of deep vein thrombosis and pulmonary embolism, the recommended initial dose is 15 mg twice daily for the first three weeks, followed by 20 mg once daily for continued treatment and prevention of recurrence. For prevention of major cardiovascular events in patients with coronary artery disease and/or peripheral artery disease, the recommended dose is 2.5 mg twice daily in combination with a daily dose of 100 mg aspirin.

Key safety warnings

With RELABAN for stroke prevention in atrial fibrillation, therapy should be continued long term provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding. The risk of bleeding increases with increasing age. Prior to commencing treatment with RELABAN, an accurate assessment of renal function should be undertaken. No clinical data are available for patients with creatinine clearance less than 15 mL/min or patients on dialysis, and use of RELABAN is contraindicated in this patient population.

Contraindications

RELABAN is contraindicated in patients with creatinine clearance less than 15 mL/min or patients on dialysis.

PBS listing

RELABAN 15 mg capsules are listed on the PBS with 2 items under streamlined restriction, with an ex-manufacturer price of A$26.99 as of 1 May 2026. RELABAN 20 mg capsules are listed on the PBS with 2 items under streamlined restriction, with an ex-manufacturer price of A$26.66 as of 1 May 2026.

Regulatory history

RELABAN 15 mg and 20 mg capsules were first listed on the ARTG on 29 April 2025 under licence category RE.