What is Eliquis - apixaban?
Eliquis is a medicine that contains the active substance apixaban. The medicine is available as tablets (2.5 mg).
What is Eliquis - apixaban used for?
Eliquis is used to prevent embolic venous thrombus episodes (problems due to the formation of blood clots in the veins) in adults following a hip or knee replacement operation.
The medicine can only be obtained with a prescription.
How is Eliquis - apixaban used?
Treatment with Eliquis should be started 12 to 24 hours after the operation. The recommended dose is one tablet twice a day, usually for more than a month (32 to 38 days) after a hip replacement or for a period ranging from 10 days to two weeks after knee replacement.
How does Eliquis - apixaban work?
In patients undergoing hip or knee replacement surgery, there is a high risk of developing blood clots in the veins. These clots can be dangerous and even fatal if they move to other parts of the body, such as in the lungs. The active substance in Eliquis, apixaban, is a "factor Xa inhibitor" which is a substance that blocks factor Xa, an enzyme that intervenes in the production of thrombin. In turn, thrombin is an indispensable element in the process of blood coagulation. By blocking factor Xa, thrombin levels are reduced and the risk of blood clots forming in the veins is reduced.
How has Eliquis - apixaban been studied?
The effects of Eliquis were first tested in experimental models before being studied in humans.
Eliquis has been studied in two main studies involving a total of 8 464 patients. The first study was carried out in 5 407 patients who underwent hip replacement. The second study was performed in 3 057 patients who underwent knee replacement. In both studies, Eliquis was compared to enoxaparin (another medicine used to prevent blood clots). The efficacy of the medicine was measured by examining the number of patients who had embolic venous thrombus episodes or who died of any cause during the treatment period.
What benefit has Eliquis - apixaban shown during the studies?
In both studies, Eliquis was effective in preventing embolic venous thrombus events and death due to any cause. In patients undergoing hip replacement, 1.4% of patients who completed Eliquis treatment (27 out of 1 949) had a venous thromboembolic event or died of any cause, compared with 3.9% (74 out of 1 917) of patients taking enoxaparin. In patients undergoing knee replacement, the corresponding numbers were 15% (147 out of 976) for Eliquis compared with 24% (243 out of 997) for enoxaparin.
What are the risks associated with Eliquis - apixaban?
The most frequent side effects recorded with Elisuis (found between 1 and 10 patients in 100) are anemia (low number of red blood cells), hemorrhage (bleeding), bruises (ecchymoses) and nausea (malaise). For the full list of all side effects reported with Eliquis, see the Package Leaflet.
Eliquis should not be used in people who may be hypersensitive (allergic) to apixaran or any of the other ingredients. It should not be used in patients who are actively bleeding or suffering from liver diseases that cause problems with blood clotting and an increased risk of bleeding.
Why has Eliquis - apixaban been approved?
The CHMP decided that Eliquis's benefits are greater than its risks and recommended that it be given marketing authorization.
More information on Eliquis - apixaban
On May 18, 2011, the European Commission granted Eliquis a marketing authorization valid throughout the European Union to Bristol-Myers Squibb / Pfizer EEIG. The marketing authorization is valid for five years, after which it can be renewed.
For more information on Eliquis therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Last update of this summary: 04-2011.
