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 begin six to ten hours after surgery, provided the patient's surgical wound is no longer bleeding. Xarelto should be taken as one tablet once daily with or without food. Treatment lasts for 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 the veins. These clots can be dangerous if they travel to other parts of the body, such as the lungs. The active substance in Xarelto, rivaroxaban, is a 'factor Xa inhibitor', which means it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is essential for the blood clotting process. By blocking factor Xa, thrombin levels are lowered 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 has been compared to enoxaparin (another medicine that prevents blood clots) in three main studies, two in patients undergoing hip replacement surgery and one in patients undergoing knee replacement surgery. In hip replacement surgery, the first study compared five weeks of Xarelto with five weeks of enoxaparin in approximately 4,500 patients and the second study compared five weeks of Xarelto with two weeks of enoxaparin in approximately 2,500 patients. The third study compared two weeks of Xarelto with two weeks of enoxaparin in approximately 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 who died from any cause during the treatment period.
What benefit has Xarelto shown during the studies?
In all of the main studies, Xarelto was found to be more effective than enoxaparin in preventing blood clots or death.
In the first hip replacement surgery study, 1% of patients receiving full treatment with Xarelto had blood clots or died (18 out of 1,595), compared with 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 out 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 with Xarelto (seen in 1 to 10 patients in 100) are bleeding after surgery, nausea, anemia (reduced number of red blood cells) and an increase in certain liver enzymes in the blood. For the complete list. of the side effects reported with Xarelto, see the package leaflet.
Xarelto must not be used in people who may be hypersensitive (allergic) to rivaroxaban or any of the other ingredients. It must not be used in patients who have blood loss or in patients who have liver disease which increases the risk of bleeding. Xarelto should not be used in women who are pregnant 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 in preventing venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. The committee recommended the granting of a marketing authorization for Xarelto.
Other information about Xarelto:
On 30 September 2008, the European Commission issued a "Marketing Authorization" for Xarelto, valid throughout the European Union. The holder of the Marketing Authorization is the Bayer Schering Pharma AG.
For the full version of the Xarelto EPAR click here.
Last update of this summary: 04-2009.
The information on Xarelto - rivaroxaban published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
