RIVOXA

What it is

RIVOXA contains rivaroxaban in film-coated tablet formulations of 2.5 mg, 10 mg, 15 mg, or 20 mg strength.

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 for the 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

For venous thromboembolism prevention in major orthopaedic surgery, the recommended dose is 10 mg once daily, with the initial dose taken 6–10 hours after surgery provided that haemostasis has been established. Treatment duration is 5 weeks for hip replacement and 2 weeks for knee replacement. For stroke prevention in atrial fibrillation, the recommended dose is 20 mg once daily. For patients with severe and moderate renal impairment (creatinine clearance 15–49 mL/min), 15 mg once daily should be taken. 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. After six to twelve months of therapy, dose reduction to 10 mg once daily may be considered based on individual assessment of recurrent risk against bleeding risk. 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.

Key safety warnings

The risk of bleeding increases with increasing age. No clinical data are available for patients with creatinine clearance less than 15 mL/min or patients on dialysis, and use of RIVOXA is contraindicated in this patient population. RIVOXA 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.

Contraindications

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

Regulatory history

RIVOXA was first registered on the ARTG on 28 March 2024, with four strengths registered: 2.5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets in blister pack formulation.