2 The technology

2 The technology

2.1 Rivaroxaban (Xarelto, Bayer) is indicated for the 'treatment of deep vein thrombosis and pulmonary embolism, and prevention of recurrent deep vein thrombosis and pulmonary embolism in adults'. For the initial treatment of acute pulmonary embolism, the recommended dosage of rivaroxaban is 15 mg twice daily for the first 21 days followed by 20 mg once daily for continued treatment and prevention of recurrent venous thromboembolism.

2.2 Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism (NICE technology appraisal guidance 261) recommends rivaroxaban as an option for treating deep vein thrombosis and preventing recurrent deep vein thrombosis and pulmonary embolism after a diagnosis of acute deep vein thrombosis in adults.

2.3 The duration of treatment recommended in the summary of product characteristics depends on bleeding risk and other clinical criteria. Short-term treatment (at least 3 months) is recommended for people with transient risk factors such as recent surgery and trauma. Longer treatment is recommended for people with permanent risk factors, or idiopathic (unprovoked) deep vein thrombosis or pulmonary embolism. A reduced dosage of 15 mg twice daily for 21 days followed by 15 mg once daily should be used in people with moderate (creatinine clearance 30–49 ml/min) or severe (creatinine clearance 15–29 ml/min) renal impairment if their risk of bleeding outweighs the risk of recurrent deep vein thrombosis or pulmonary embolism.

2.4 The summary of product characteristics lists the following adverse reactions for rivaroxaban: anaemia, dizziness, headache, fainting, bleeding events, tachycardia (rapid heartbeat), low blood pressure, haematoma, stomach pain, dyspepsia (heartburn), nausea, constipation, diarrhoea, vomiting, pruritus (itching), rash, bruising, pain in the extremities, fever, and swelling, especially of the ankles and feet. For full details of side effects and contraindications, see the summary of product characteristics.

2.5 Rivaroxaban costs £2.10 per 15‑mg or 20‑mg tablet ('British national formulary' edition 65). The cost of treatment is estimated to be £235.86, £427.61 and £811.13 for 3, 6 and 12 months of treatment respectively. Costs may vary in different settings because of negotiated procurement discounts.

  • National Institute for Health and Care Excellence (NICE)