Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation

2.1 Rivaroxaban (Xarelto, Bayer HealthCare) is an anticoagulant that directly inhibits activated factor X (factor Xa). Factor Xa is a key component in the formation of blood clots. Rivaroxaban has a UK marketing authorisation for the 'prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors such as: congestive heart failure, hypertension, age 75 years or older, diabetes mellitus, prior stroke or transient ischaemic attack'.

2.2 According to the summary of product characteristics, approximately 14% of people treated with rivaroxaban in clinical studies experienced adverse reactions. Bleeding occurred in approximately 3.3% of patients and anaemia in approximately 1% of patients. Other common adverse reactions were nausea and an increase in transaminases. The summary of product characteristics states that the risk of bleeding may be increased in certain patient groups, for example those with uncontrolled severe arterial hypertension and/or those taking other treatments that affect haemostasis. For full details of adverse reactions and contraindications see the summary of product characteristics.

2.3 The price of rivaroxaban is £58.80 for a pack of 28 15-mg tablets and £58.80 for a pack of 28 20‑mg tablets (MIMS March 2012). Costs may vary in different settings because of negotiated procurement discounts.