ARX-RIVAROXABAN

What it is

ARX-RIVAROXABAN is a film-coated tablet containing rivaroxaban in strengths of 2.5 mg, 10 mg, 15 mg, or 20 mg.

Approved indications

— 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 prevention of recurrent deep vein thrombosis and pulmonary embolism. — 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

Dosing varies by indication. For venous thromboembolism prevention in major orthopaedic surgery, the recommended dose is 10 mg once daily. 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 15–49 mL/min). For treatment of deep vein thrombosis and pulmonary embolism, the recommended 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 coronary artery disease and/or peripheral artery disease, the recommended dose is 2.5 mg twice daily in combination with 100 mg aspirin daily. ARX-RIVAROXABAN 2.5 mg and 10 mg tablets may be taken with or without food, whilst 15 mg and 20 mg tablets should be taken with food.

Key safety warnings

Caution should be taken in patients with severe renal impairment (creatinine clearance 15–29 mL/min) due to limited clinical data. No clinical data are available for patients with creatinine clearance less than 15 mL/min or patients on dialysis, therefore use of ARX-RIVAROXABAN is contraindicated in these patient populations. ARX-RIVAROXABAN should be used with caution in patients with renal impairment who are concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations. The risk of bleeding increases with increasing age. Therapy with ARX-RIVAROXABAN should be continued long term for atrial fibrillation provided the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding.

Contraindications

Use of ARX-RIVAROXABAN is contraindicated in patients with creatinine clearance less than 15 mL/min or patients on dialysis.

Regulatory history

ARX-RIVAROXABAN was first listed on the ARTG on 13 June 2023, with three strengths registered: 10 mg, 15 mg, and 20 mg tablets.