What is Xarelto?
Xarelto is a medicine that contains the active substance rivaroxaban. It is available as red round tablets (10 mg).
What is Xarelto used for?
Xarelto is used to prevent venous thromboembolism (VTE, formation of blood clots in the veins) in adults undergoing hip or knee replacement surgery.
The medicine can only be obtained with a prescription.
How is Xarelto used?
Treatment with Xarelto should start six to ten hours after surgery, provided that the patient's surgical wound is no longer bleeding. Xarelto should be taken at a dose of one tablet once a day with or without food. Treatment lasts five weeks in patients undergoing hip replacement surgery and two weeks in patients undergoing knee replacement surgery.
How does Xarelto work?
Patients undergoing hip or knee replacement surgery have a high risk of blood clots forming in their veins. These clots can be dangerous if they move to other parts of the body, such as in the lungs. The active substance in Xarelto, rivaroxaban, is a "factor Xa inhibitor", which is a substance that blocks factor Xa, an enzyme that intervenes in the production of thrombin. Thrombin is essential for the blood coagulation process. By blocking factor Xa, thrombin levels are reduced and the risk of blood clots forming in the veins is reduced.
How has Xarelto been studied?
The effects of Xarelto were first tested in experimental models before being studied in humans.
Xarelto was compared to enoxaparin (another medicine that prevents the formation of blood clots) in three main studies, two in patients undergoing hip replacement surgery and one in patients undergoing knee replacement surgery. In the hip replacement surgery, the first study compared five weeks of Xarelto with five weeks of enoxaparin in about 4, 500 patients and the second study compared five weeks of Xarelto with two weeks of enoxaparin in about 2, 500 patients. The third study compared two weeks of Xarelto with two weeks of enoxaparin in about 2, 500 patients undergoing knee replacement surgery. In all studies, efficacy was measured by the number of patients who had blood clots in their veins or lungs or died from any cause during the treatment period.
What benefit has Xarelto shown during the studies?
In all the main studies, Xarelto was more effective than enoxaparin in preventing the formation of blood clots or death.
In the first hip replacement intervention study, 1% of patients who underwent complete treatment with Xarelto had blood clots or died (18 out of 1, 595), compared to 4% of those treated with enoxaparin (58 out of 1, 558). In the second study, 2% of patients treated with Xarelto had blood clots or died (17 of 864), compared with 9% of those treated with enoxaparin (81 out of 869).
After knee replacement surgery, 10% of patients treated with Xarelto had blood clots or died (79 out of 824), compared with 19% of those treated with enoxaparin (166 out of 878).
What is the risk associated with Xarelto?
The most common side effects of Xarelto (seen in between 1 and 10 patients in 100) are bleeding after the operation, nausea, anemia (reduction in the number of red blood cells) and increase in certain liver enzymes in the blood. For the full list of all side effects reported with Xarelto, see the Package Leaflet.
Xarelto should not be used in people who may be hypersensitive (allergic) to rivaroxaban or any of the other ingredients. It should not be given to patients who have blood loss or to patients who have liver disease that increases the risk of bleeding. Xarelto should not be used in women during pregnancy or breastfeeding.
Why has Xarelto been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Xarelto's benefits are greater than its risks for the prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement procedures. The committee recommended that Xarelto be given marketing authorization.
Other information about Xarelto:
On 30 September 2008, the European Commission issued a marketing authorization for Xarelto, valid throughout the European Union. The marketing authorization holder is Bayer Schering Pharma AG.
The full EPAR for Xarelto can be found here.
Last update of this summary: 04-2009.
