RIVAROXABAN LUPIN

What it is

APO-RIVAROXABAN is available as film-coated tablets in strengths of 2.5 mg, 10 mg, 15 mg and 20 mg, each containing the stated amount of rivaroxaban as the active ingredient.

Approved indications

— Prevention of venous thromboembolism in adult patients who have undergone elective total hip replacement (treatment for up to 5 weeks) or 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 in combination with aspirin in patients with coronary artery disease and/or peripheral artery disease.

Dosing overview

APO-RIVAROXABAN 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

Limited clinical data are available in patients with severe renal impairment (Creatinine clearance 15–29 mL/min), and caution should be taken in this population. No clinical data are available for patients with creatinine clearance less than 15 mL/min or patients on dialysis, and use of APO-RIVAROXABAN is contraindicated in this population. Increasing age is associated with declining renal function, and the risk of bleeding increases with increasing age. Therapy should be continued long term only if the benefit of prevention of stroke and systemic embolism outweighs the risk of bleeding.

Contraindications

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

Regulatory history

APO-RIVAROXABAN tablets in strengths of 2.5 mg, 10 mg, 15 mg and 20 mg were first listed on the Australian Register of Therapeutic Goods on 4 March 2024.