RIVAXIB

What it is

RIVAXIB contains rivaroxaban and is available in film-coated tablets of 2.5 mg, 10 mg, 15 mg and 20 mg strengths.

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

For prevention of venous thromboembolism in major orthopaedic surgery, the recommended dose is 10 mg taken 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. For patients with severe and moderate renal impairment (creatinine clearance 15–49 mL/min), one 15 mg tablet should be taken once daily. 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. RIVAXIB 2.5 mg and 10 mg tablets may be taken with or without food, while 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, and use of RIVAXIB is contraindicated in this patient population. Increasing age is associated with declining renal function, and the risk of bleeding increases with increasing age.

Contraindications

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

PBS listing

In November 2024, RIVAXIB was recommended for PBS listing for prevention of venous thromboembolism and chronic stable atherosclerotic disease with Authority Required (Streamlined) status for new pack sizes (2.5 mg 98-pack and 10 mg 14-pack).

Regulatory history

RIVAXIB was first listed on the ARTG on 8 June 2023, with registrations for 10 mg, 15 mg and 20 mg film-coated tablets under licence category RE. The product received a positive PBAC recommendation in November 2024 for Prevention of venous thromboembolism and Chronic stable atherosclerotic disease indications.