Active Substance: apixaban
Common Name: apixaban
ATC Code: B01AF02
Marketing Authorisation Holder: Bristol-Myers Squibb / Pfizer EEIG
Active Substance: apixaban
Authorisation Date: 2011-05-18
Therapeutic Area: Arthroplasty Venous Thromboembolism
Pharmacotherapeutic Group: Antithrombotic agents
Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip- or knee-replacement surgery.
What is Eliquis?
Eliquis is a medicine that contains the active substance apixaban. It is available as tablets (2.5 mg, 5 mg).
What is Eliquis used for?
Eliquis is used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation.
Eliquis is also used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as having had a previous stroke, high blood pressure, diabetes, heart failure or being 75 years old or over.
The medicine can only be obtained with a prescription.
How is Eliquis used?
For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation. The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month (32 to 38 days) after a hip replacement or for 10 to 14 days after a knee replacement.
For patients with atrial fibrillation at risk of stroke or blood clots, the recommended dose is 5 mg taken twice a day.
How does Eliquis work?
Patients undergoing hip or knee replacement surgery are at a high risk of blood clots forming in the veins, which can be dangerous and even fatal if they move to another part of the body such as the lungs. Similarly, patients with atrial fibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke.
The active substance in Eliquis, apixaban, is a â€˜factor Xa inhibitorâ€™. 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, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.
How has Eliquis been studied?
The effectiveness of Eliquis in preventing blood clots in veins following a hip or knee replacement was investigated in two main studies involving a total of 8,464 patients. The first study was in 5,407 patients who had undergone a hip replacement. The second study was in 3,057 patients who had undergone a knee replacement. In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots). The medicineâ€™s effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during the treatment period.
The effectiveness of Eliquis in preventing strokes and arterial blood clots in patients with atrial fibrillation was investigated in two main studies: the first (in 18,201 patients) compared Eliquis with another medicine, warfarin, while the second (in 5,598 patients) compared Eliquis with aspirin. The main measures of effectiveness were based on the number of strokes or clotting events that occurred during treatment.
What benefit has Eliquis shown during the studies?
Eliquis was effective at preventing blood clots in the veins following a hip or knee replacement. In patients undergoing a hip replacement, 1.4% of the patients who completed treatment with Eliquis (27 out of 1,949) had a clotting event or died from any cause, compared with 3.9% (74 out of 1,917) of the patients taking enoxaparin. In patients undergoing a knee replacement, the corresponding numbers were 15% (147 out of 976) for Eliquis compared with 24% (243 out of 997) for enoxaparin.
Eliquis was also shown to be effective in preventing strokes and arterial blood clots. In the study comparing Eliquis with warfarin, 1.3 % of the patients taking Eliquis had a stroke or clotting event every year compared with 1.6% of the patients taking warfarin. The yearly rates in the second study were 1.6% for patients taking Eliquis and 3.6% for patients taking aspirin.
What is the risk associated with Eliquis?
The most frequent adverse reactions (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), contusion (bruising) and nausea (feeling sick) when Eliquis is used for prevention of venous thromboembolism. When used for the prevention of stroke or systemic embolism the most common are epistaxis (nose bleeds), contusion (bruising), haematuria (blood in urine) and bleeding in the gut and eye. For the full list of all side effects reported with Eliquis, see the package leaflet.
Eliquis must not be used in patients who are hypersensitive (allergic) to apixaban or any of the other ingredients. It must not be used in patients who are actively bleeding, or who have liver disease which leads to problems with blood clotting and an increased risk of bleeding. The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances (see summary of product characteristics).
Why has Eliquis been approved?
The CHMP decided that the benefits of Eliquis are greater than its risks and recommended that it be given marketing authorisation.
Other information about Eliquis
The European Commission granted a marketing authorisation valid throughout the European Union for Eliquis on 18 May 2011.
For more information about treatment with Eliquis, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.