Author: Bayer Schering Pharma AG


Long information

What is it?

Xarelto is a medicine that contains the active substance rivaroxaban. It is available as red, round tablets (10 mg).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Xarelto is used to prevent venous thromboembolism (VTE, the formation of clots in the veins) in adults who are undergoing surgery to replace a hip or knee.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Xarelto should start six to 10 hours after surgery, provided that the patient is no longer bleeding from the site of surgery. Xarelto is taken as one tablet once a day, with or without food. Treatment should continue for five weeks in patients who have had hip replacement surgery, and for two weeks in patients who have had knee replacement surgery.

How does it work?

Patients undergoing hip or knee replacement surgery are at a high risk of forming blood clots in the veins. These clots can be dangerous if they move to another part 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 is central to the process of blood clotting. By blocking factor Xa, the levels of thrombin decrease, which reduces the risk of blood clots forming in the veins.

How has it been studied?

Xarelto was compared with enoxaparin (another medicine that prevents the blood from clotting) 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 around 4,500 patients, and the second study compared five weeks of Xarelto with two weeks of enoxaparin in around 2,500 patients. The third study compared two weeks of Xarelto with two weeks of enoxaparin in around 2,500 patients undergoing knee replacement surgery. In all of the studies, the effectiveness was measured by looking at the number of patients who either had blood clots in the veins or in the lungs, or who died of any cause during the treatment period.

What benefits has it shown during the studies?

In all of the main studies, Xarelto was more effective than enoxaparin in preventing the formation of blood clots or death.

In the first study in hip replacement surgery, 1% of the patients who completed treatment with Xarelto either had blood clots or died (18 out of 1,595), compared with 4% of the patients receiving enoxaparin (58 out of 1,558). In the second study, 2% of the patients taking Xarelto had blood clots or died (17 out of 864), compared with 9% of the patients receiving enoxaparin (81 out of 869).

After knee replacement surgery, 10% of the patients receiving Xarelto had blood clots or died (79 out of 824), compared with 19% of the patients receiving enoxaparin (166 out of 878).

What is the risk associated?

The most common side effects with Xarelto (seen in between 1 and 10 patients in 100) are bleeding and anaemia (low red blood cell counts) following an operation, nausea (feeling sick), fever, peripheral oedema (swelling, especially of the ankles and feet) and increased levels of some 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 must not be used in patients who are bleeding or in patients who have a liver disease that is associated with an increased risk of bleeding. Xarelto must not be used in women who are pregnant or breast-feeding.

Why has it been approved?

The CHMP decided that Xarelto?s benefits are greater than its risks and recommended that it be given marketing authorisation.

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