IXAROLA

What it is

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

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 to 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 recurrent events. Following completion of six to twelve months therapy, dose reduction to 10 mg once daily may be considered. 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

IXAROLA 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. Caution should be taken in patients with severe renal impairment (Creatinine clearance 15–29 mL/min) due to limited clinical data. IXAROLA should be used with caution in patients with renal impairment concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations.

Contraindications

IXAROLA is contraindicated in patients with Creatinine clearance less than 15 mL/min or in patients on dialysis, as no clinical data are available for these populations.

Regulatory history

IXAROLA (rivaroxaban) 2.5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets were first listed on the ARTG on 7 February 2023.