Eliquis

apixaban

  • Email
  • Help

About

An overview of Eliquis and why it is authorised in the EU

Eliquis is a medicine used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation. It is also used in adults to treat deep vein thrombosis (blood clot in a deep vein, usually in the leg) and pulmonary embolism (clot in a blood vessel supplying the lungs), and to prevent their reoccurrence.

Additionally, Eliquis is 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, having high blood pressure, diabetes, heart failure or being 75 years old or over.

Eliquis contains the active substance apixaban.

How is Eliquis used?

Eliquis can only be obtained with a prescription. It is available as tablets (2.5 mg, 5 mg).

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.

For the treatment of deep vein thrombosis and pulmonary embolism, the recommended dose is 10 mg twice a day for the first week, followed by 5 mg twice a day for at least 3 months. To prevent deep vein thrombosis and pulmonary embolism from reoccurring, the recommended dose is 2.5 mg twice a day.

For more information about using Eliquis, see the package leaflet or contact your doctor or pharmacist.

How does Eliquis work?

Patients undergoing hip or knee replacement surgery, who have had a recent trauma, or are confined to bed 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 ‘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, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins.

What benefits of Eliquis have been shown in studies?

Eliquis was effective at preventing blood clots in the veins following a hip or knee replacement in two main studies involving a total of 8,464 patients. In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots). The medicine’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. 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 patients with atrial fibrillation 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. 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.

Eliquis was also effective at treating deep vein thrombosis and pulmonary embolism and preventing their reoccurrence in two main studies. In the treatment study conducted in 5,395 patients, Eliquis was compared with enoxaparin followed by warfarin; the main measure of effectiveness was based on the number of patients who either had blood clots in the veins of the legs or lungs or died because of this during the treatment period. 2.3% of patients treated with Eliquis had a clot or died, compared with 2.7% of patients treated with enoxaparin plus warfarin, showing that Eliquis was as effective as the comparator treatment.

In the prevention study in 2,482 patients, Eliquis was compared with placebo (a dummy treatment) and its 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 treatment. 2.3% of patients taking Eliquis (2.5 mg twice a day) experienced a clot or died, compared with 9.3% of patients taking placebo.

What are the risks associated with Eliquis?

The most frequent side effects with Eliquis (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), haematoma (a collection of blood under the skin), contusion (bruising), nausea (feeling sick), low blood pressure (hypotension), epistaxis (nose bleeds), haematuria (blood in urine), low blood platelet counts (thrombocytopenia), blood tests showing alanine aminotransferase and gamma-glutamyltransferase increase and skin rash. Some of these side effects are not seen with all the uses of Eliquis.

Eliquis 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).

For the full list of side effects and restrictions with Eliquis, see the package leaflet.

Why is Eliquis authorised in the EU?

The European Medicines Agency decided that Eliquis’ benefits are greater than its risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Eliquis?

The company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eliquis have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Eliquis are continuously monitored. Side effects reported with Eliquis are carefully evaluated and any necessary action taken to protect patients.

Other information about Eliquis

Eliquis received a marketing authorisation valid throughout the EU on 18 May 2011.

Name Language First published Last updated
Eliquis : EPAR - Summary for the public BG = bălgarski 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public ES = español 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public CS = čeština 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public DA = dansk 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public DE = Deutsch 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public ET = eesti keel 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public EL = elliniká 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public EN = English 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public FR = français 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public IT = italiano 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public LV = latviešu valoda 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public LT = lietuvių kalba 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public HU = magyar 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public MT = Malti 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public NL = Nederlands 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public PL = polski 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public PT = português 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public RO = română 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public SK = slovenčina 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public SL = slovenščina 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public FI = suomi 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public SV = svenska 2011-06-20 2018-08-01
Eliquis : EPAR - Summary for the public HR = Hrvatski 2011-06-20 2018-08-01

This EPAR was last updated on 01/08/2018 .

Authorisation details

Product details

Product details for Eliquis
NameEliquis
Agency product numberEMEA/H/C/002148
Active substance

apixaban

International non-proprietary name (INN) or common name

apixaban

Therapeutic area ArthroplastyVenous Thromboembolism
Anatomical therapeutic chemical (ATC) code B01AF02

Publication details

Publication details for Eliquis
Marketing-authorisation holder

Bristol-Myers Squibb / Pfizer EEIG

Revision15
Date of issue of marketing authorisation valid throughout the European Union18/05/2011

Contact address:

Bristol-Myers Squibb / Pfizer EEIG
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Product information

Product information

17/05/2018  Eliquis -EMEA/H/C/002148 -II/0051

Name Language First published Last updated
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01
Eliquis : EPAR - Product Information HR = Hrvatski 2011-06-20 2018-08-01

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29
Eliquis : EPAR - All Authorised presentations HR = Hrvatski 2011-06-20 2014-09-29

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

For Eliquis 2.5 mg film-coated tablets

  • Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 
  • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). 
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients). 

For Eliquis 5 mg film-coated tablets

  • Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). 
  • Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults (see section 4.4 for haemodynamically unstable PE patients).

Assessment History