Overview

Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:

  • to prevent stroke (caused by blood clots in the brain) and systemic embolism (blood clots in other organs) in patients with non-valvular 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 high blood pressure, diabetes, heart failure, having had a stroke or being 75 years old or over;
  • to treat deep-vein thrombosis (DVT, a blood clot in a deep vein, usually in the leg) and pulmonary embolism (a clot in a blood vessel supplying the lungs), and to prevent DVT and pulmonary embolism from re-occurring.

Lixiana contains the active substance edoxaban.

Lixiana is available as tablets and can only be obtained with a prescription. The usual dose is 60 mg once a day but doses may be adjusted for kidney function, low body weight or in those who are also taking certain medicines (known as P-gp inhibitors) that can interfere with the removal of edoxaban from the body. Dose adjustments may also need to be made in patients who are switched between Lixiana and other anticoagulant medicines. Treatment is continued while the benefit outweighs the risk of bleeding, which depends on the condition being treated and any existing risk factors. For more information about using Lixiana, see the package leaflet or contact your doctor or pharmacist.

The active substance in Lixiana, edoxaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is essential for blood clotting. By blocking factor Xa, the medicine reduces the levels of thrombin in the blood, which helps treat clots and reduce the risk of them forming in the arteries and veins and leading to DVT, pulmonary embolism, stroke or other organ damage.

Lixiana has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation. The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years. The main measure of effectiveness was the rate of stroke or systemic embolism among the patients each year. A first systemic embolism or stroke occurred in around 1.2% of those given standard doses of Lixiana and 1.5% of those given warfarin respectively. When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 0.9% of patients given Lixiana and 1% of those given warfarin. There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.

In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Lixiana was also found to be as effective as warfarin, in a study involving over 8,200 patients. The main measure of effectiveness was the number of patients who had another episode of DVT or pulmonary embolism during the study period. Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).

The most common side effects with Lixiana (which may affect up to 1 in 10 people) are nose bleeds (epistaxis), blood in the urine (haematuria) and anaemia (low levels of red blood cells). Bleeding can occur at any site and can be severe or even fatal. For the full list of side effects of Lixiana, see the package leaflet.

Lixiana must not be used in patients who are actively bleeding, have liver diseases that affect blood clotting, have severe uncontrolled high blood pressure or who have a condition putting them at significant risk of major bleeding. It must also not be used in pregnant or breastfeeding women or in patients also being treated with another anticoagulant. For the full list of restrictions, see the package leaflet.

The European Medicines Agency decided that Lixiana’s benefits are greater than its risks and it can be authorised for use in the EU. The medicine has been shown to be at least as effective as warfarin in reducing stroke rates in patients with atrial fibrillation and in preventing further episodes of DVT or pulmonary embolism.

With respect to safety, overall the risk of serious bleeding such as bleeding into the brain was reduced compared with warfarin, although there may be less difference where warfarin treatment is well managed. Although there was greater a risk of bleeding from the mucosa (tissues lining body cavities such as the nose, gut and vagina), the Agency considered that the risk could be managed with appropriate measures.

The company that markets Lixiana will provide educational materials for doctors prescribing the medicine and an alert card for patients, explaining the risks of bleeding with the medicine and how to manage them.

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

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

Lixiana received a marketing authorisation valid throughout the EU on 19 June 2015.

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Latest procedure affecting product information: WS2409

29/11/2023

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Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

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Product details

Name of medicine
Lixiana
Active substance
edoxaban tosilate
International non-proprietary name (INN) or common name
edoxaban
Therapeutic area (MeSH)
  • Stroke
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).

Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Authorisation details

EMA product number
EMEA/H/C/002629
Marketing authorisation holder
Daiichi Sankyo Europe GmbH

Zielstattstrasse 48
81379 Munich
Germany

Opinion adopted
23/04/2015
Marketing authorisation issued
19/06/2015
Revision
19

Assessment history

Topics

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