RIVARELTO

What it is

RIVARELTO contains rivaroxaban and is available in film-coated tablets of 2.5 mg, 10 mg, 15 mg, and 20 mg strength. The 2.5 mg and 10 mg tablets may be taken with or without food, while the 15 mg and 20 mg tablets should be taken with food.

Approved indications

— Prevention of venous thromboembolism in adult patients who have undergone major orthopaedic surgery of the lower limbs (elective total hip replacement for up to 5 weeks; elective total knee replacement 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

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. 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 acute 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. Following six to twelve months of therapy, dose reduction to 10 mg once daily may be considered based on individual assessment of recurrent risk versus 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 initial dose for venous thromboembolism prevention should be taken 6–10 hours after surgery provided that haemostasis has been established. 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 RIVARELTO is contraindicated in this patient population. The risk of bleeding increases with increasing age.

Contraindications

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

Regulatory history

RIVARELTO rivaroxaban tablets in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths were first listed on the ARTG on 31 January 2023.