Xarelto is a medicine which contains the active substance rivaroxaban. It is available in red tablets, round (10 mg).
What is Xarelto Used?
Xarelto is used to prevent venous thromboembolism (VTE, blood clots in the veins) in adults who are undergoing surgery for hip or knee substitution.
The medicine can only be obtained with a prescription.
How is Xarelto?
Treatment with Xarelto should start six to 10 hours after surgery, provided that patients do not bleed at surgery. Xarelto is taken as one tablet once daily with or without food. Treatment should continue for five weeks in patients who were undergoing hip replacement and for two weeks in patients who were undergoing knee replacement.
How does Xarelto?
Patients who are undergoing hip replacement or knee shows an increased risk of blood clots in the veins. These clots can be dangerous if they move to other areas of the body such as the lungs. The active substance in Xarelto, rivaroxaban, is a “Factor Xa inhibitor”. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin plays a pivotal role in blood clotting process. By blocking factor Xa, thrombin levels decrease, which reduces the risk of blood clots in the veins.
How has Xarelto been Studied?
The effects of Xarelto were first tested in experimental models before being studied in humans.
Xarelto was compared with enoxaparin (another medicine that prevents blood clotting) in three main studies, two in patients undergoing hip replacement surgery for patients undergoing surgery and a knee replacement.
In case of intervention replacement hip, the first study compared five weeks of Xarelto with five weeks of enoxaparin in 4500 patients, and the second study compared five weeks of Xarelto with the two weeks of enoxaparin in approximately 2500 patients. The third study compared two weeks of Xarelto with two weeks of enoxaparin in approximately 2500 patients undergoing knee surgery replacement. In all studies, effectiveness was measured based on the number of patients who either had blood clots in the veins or lungs, or who died for one reason or another during treatment.
What Benefit has Xarelto Shown During the Studies?
In all the main studies, Xarelto was more effective than enoxaparin in preventing blood clots or death.
In the first study intervention replacement hip, 1% of patients who have undergone complete treatment with Xarelto either had blood clots or died (18 of 1595), compared to 4% of patients who received enoxaparin (58 in 1558). In the second study, 2% of patients taking Xarelto had blood clots or died (17 of 864), compared with 9% of patients receiving enoxaparin (81 of 869).
After knee replacement surgery, 10% of patients taking Xarelto had blood clots or died (79 of 824), compared with 19% of patients who received enoxaparin (166 of 878).
Risks Associated with Xarelto?
The most common side effects with Xarelto (seen in between 1 and 10 patients in 100) are bleeding after surgery, nausea (feeling sick), anemia (low red blood cell) and increased levels of 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 ingredients. It should not be administered to patients who are bleeding or in patients who have liver disease associated with an increased risk of bleeding. Xarelto should not be used in women who are pregnant or nursing.
Why it was Approved Xarelto?
Committee for Medicinal Products for Human Use (CHMP) decided that Xarelto’s benefits are greater than its risks for the prevention of VTE in adult patients who undergo elective surgery for hip or knee substitution. The Committee recommended granting marketing authorization for Xarelto.
Other Information about Xarelto:
The European Commission granted a marketing authorization for Xarelto, valid throughout the European Union on 30 September 2008. The marketing authorization holder is Bayer Schering Pharma AG.