XARELTO

What it is

XARELTO (rivaroxaban) is available as film-coated tablets containing 2.5 mg, 10 mg, 15 mg, or 20 mg of rivaroxaban. Rivaroxaban is a direct Factor Xa inhibitor developed as an oral anticoagulant alternative, aiming to offer a predictable dose-response without the need for routine laboratory monitoring.

Approved indications

— Prevention of venous thromboembolism (VTE) 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 (DVT) and pulmonary embolism (PE) and for the prevention of recurrent DVT and PE. — Prevention of major cardiovascular events (composite of stroke, myocardial infarction and cardiovascular death) in patients with coronary artery disease (CAD) and/or peripheral artery disease (PAD), in combination with aspirin.

Dosing overview

XARELTO 2.5 mg tablets and 10 mg tablets may be taken with or without food, whilst 15 mg tablets and 20 mg tablets should be taken with food.

Key safety warnings

The risk of bleeding increases with increasing age. Caution should be taken in patients with severe renal impairment (Creatinine clearance 15–29 mL/min) due to limited clinical data. Prior to commencing treatment with XARELTO, an accurate assessment of renal function should be undertaken, especially if there is any suspicion that the person may have a degree of renal impairment.

Contraindications

Use of XARELTO is contraindicated in patients with creatinine clearance less than 15 mL/min or patients on dialysis, as no clinical data are available for these populations. XARELTO is contraindicated in patients with significant hepatic disease, including moderate to severe hepatic impairment (Child-Pugh B and C), which is associated with coagulopathy leading to a clinically relevant bleeding risk.

PBS listing

XARELTO 10 mg tablets are listed on the PBS with streamlined restriction at an ex-manufacturer price of A$11.39. XARELTO 2.5 mg tablets are listed with streamlined restriction at an ex-manufacturer price of A$20.11. XARELTO 15 mg tablets are listed with streamlined restriction at an ex-manufacturer price of A$20.05. XARELTO 20 mg tablets are listed with streamlined restriction at an ex-manufacturer price of A$19.81.

Regulatory history

XARELTO 10 mg tablets were first listed on the ARTG on 24 November 2008. XARELTO 15 mg and 20 mg tablets were first listed on the ARTG on 13 April 2012. The TGA approved an extension of indications on 27 June 2013 to include treatment of pulmonary embolism for 15 mg and 20 mg tablets. XARELTO 2.5 mg tablets were first listed on the ARTG on 11 January 2019. In November 2014, the PBAC recommended extending the PBS listing of rivaroxaban for DVT and PE to include treatment and prevention of recurrent events. In November 2017, the PBAC recommended an amendment to allow rivaroxaban for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation who are unsuitable for warfarin. In July 2020, the PBAC recommended a new listing for patients with coronary artery disease or peripheral artery disease at high risk of recurrent cardiovascular events.