Product Dossier
APO-RIVAROXABAN
Product Dossier for APO-RIVAROXABAN (rivaroxaban 2.5 mg, Arrotex Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Arrotex Pharmaceuticals
- Active ingredient: rivaroxaban 2.5 mg
- Therapeutic area: Cardiology
- Same area: ATOZET
- Same area: OPSUMIT
What it is
APO-RIVAROXABAN is a film-coated tablet containing rivaroxaban in strengths of 2.5 mg, 10 mg, 15 mg, or 20 mg.
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 patients with severe and moderate renal impairment (creatinine clearance 15–49 mL/min) receiving APO-RIVAROXABAN for stroke prevention in atrial fibrillation, a dose of 15 mg once daily should be taken. 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
No clinical data are available for patients with creatinine clearance less than 15 mL/min or patients on dialysis; therefore, use of APO-RIVAROXABAN is contraindicated in this patient population. Caution should be taken in patients with severe renal impairment (creatinine clearance 15–29 mL/min) due to limited clinical data. The risk of bleeding increases with increasing age. APO-RIVAROXABAN should be used with caution in patients with renal impairment who are concomitantly receiving other medicinal products which increase rivaroxaban plasma concentrations.
Contraindications
Use of APO-RIVAROXABAN is contraindicated in patients with creatinine clearance less than 15 mL/min or patients on dialysis.
Regulatory history
APO-RIVAROXABAN was registered on the ARTG in all four strengths (2.5 mg, 10 mg, 15 mg, and 20 mg film-coated tablets) on 3 October 2023.