Where is xarelto approved

The trials compared Xarelto 10 mg once daily starting at least 6 to 8 hours after wound closure versus enoxaparin 40 mg once daily started 12 hours preoperatively. After Day 13, oral placebo was continued in the enoxaparin group for the remainder of the double-blind study duration. Rivaroxaban also demonstrated a similar rate of major bleeding to enoxaparin 0. Rivaroxaban demonstrated a similar rate of major bleeding compared to enoxaparin 0.

RECORD 3 This randomized, double-blind study enrolled 1, subjects undergoing elective total knee replacement surgery. The trial compared Xarelto 10 mg once daily started at least 6 to 8 hours after wound closure versus enoxaparin 40 mg once daily started 12 hours preoperatively.

The mean exposure duration to active Xarelto and enoxaparin was Major VTE occurred in 1. Symptomatic VTE occurred in 1. Major bleeding rates were 0. The FDA approval of Xarelto for the reduction in the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation was based on a multi-national, double-blind, non-inferiority study.

The median treatment duration was days. Xarelto demonstrated non-inferiority to warfarin for the primary composite endpoint of time to first occurrence of stroke any type or non-CNS systemic embolism, but superiority to warfarin was not demonstrated. The trial examined the use of Xarelto, alone or in combination with aspirin, for the long-term prevention of major adverse CV events, including heart attack, stroke and CV death.

The intended treatment duration in the study was up to 12 months. Patients with an indication for continued therapeutic-dose anticoagulation were excluded. Because the benefit-risk assessment favored the 10 mg dose versus aspirin compared to the 20 mg dose versus aspirin, only the data concerning the 10 mg dose is discussed below. A total of patients were randomized and followed on study treatment for a mean of days for the XARELTO and aspirin treatment groups.

The efficacy and safety of XARELTO for prophylaxis of venous thromboembolism in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding was evaluated in the MAGELLAN study Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabaN with enoxaparin.

A total of patients were evaluable for the major efficacy outcome analysis. A primary efficacy outcome event occurred in 78 of patients 2. In the study in patients with acute DVT, 2. In the study in patients with pulmonary embolism, 2. An additional study involved over 3, adults who had completed 6 to 12 months of treatment for DVT and pulmonary embolism.

Patients received either 10 mg or 20 mg Xarelto daily, or aspirin daily for an additional 12 months. Results showed that 1. For the prevention of VTE after surgery, Xarelto was more effective than enoxaparin in three main studies, two in adults undergoing hip replacement surgery and one in adults undergoing knee replacement surgery:. For the prevention of stroke and systemic embolism in non-valvular atrial fibrillation, Xarelto was more effective than warfarin in one main study in over 14, adult patients: 2.

For the prevention of atherothrombotic events in patients with acute coronary syndrome, Xarelto was compared with placebo a dummy treatment in one main study involving over 15, adults who had recently had an acute coronary syndrome.

All patients also received standard antiplatelet medicines. In the study in patients who have had acute coronary syndrome, 6. In a study involving around 30, patients at high risk of ischaemic events with coronary artery disease or symptomatic peripheral artery disease, 4. Xarelto was compared with standard-of-care anticoagulation medicines in the prevention of VTE recurrence in children and adolescents aged less than 18 years old with acute VTE.

In a study involving patients, 1. The most common side effects with Xarelto which may affect up to 1 in 10 people are bruising and bleeding in various parts of the body, anaemia, dizziness, headache, hypotension low blood pressure , pain in the stomach and belly, dyspepsia indigestion , nausea, constipation, diarrhoea, vomiting, pruritus itching , rash, pain in the arms and legs, decreased kidney function, fever, peripheral oedema swelling, especially of the ankles and feet , decreased general strength and energy, increased levels of some liver enzymes in the blood and oozing of blood or fluid from a surgical wound.

For the full list of side effects of Xarelto, see the package leaflet. Xarelto must not be used in patients who are bleeding or in patients who have a liver disease or a condition that increases the risk of bleeding.

Xarelto must not be used together with any other anticoagulant medicines, except in specific circumstances. Xarelto must not be used in women who are pregnant or breast-feeding.

For the full list of restrictions, see the package leaflet. The company that markets Xarelto will provide an educational pack for doctors who prescribe Xarelto, containing important safety information including on the risk of bleeding during treatment with Xarelto and how to manage this risk.

In addition, it will provide a patient alert card containing key safety reminders for patients receiving Xarelto.

The company will also provide a training video to explain to healthcare professionals and caregivers how to properly prepare and give the Xarelto oral suspension. The company will also gather more data on the safety of Xarelto when used in patients who have had acute coronary syndrome. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Xarelto have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Xarelto are continuously monitored. Side effects reported with Xarelto are carefully evaluated and any necessary action taken to protect patients. Xarelto received a marketing authorisation valid throughout the EU on 30 September More detail is available in the summary of product characteristics.

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring. Xarelto, co-administered with acetylsalicylic acid ASA alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome ACS with elevated cardiac biomarkers.

Xarelto, co-administered with acetylsalicylic acid ASA , is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease CAD or symptomatic peripheral artery disease PAD at high risk of ischaemic events. Prevention of venous thromboembolism VTE in adult patients undergoing elective hip or knee replacement surgery.

Treatment of venous thromboembolism VTE and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Treatment of venous thromboembolism VTE and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Please do not include any personal data , such as your name or contact details. Skip to main content. Veterinary regulatory Overview Research and development Marketing authorisation Post-authorisation.

Xarelto RSS. Table of contents Overview Authorisation details Product information Assessment history. Patient safety. Patient safety information. Xarelto is an anticoagulant medicine a medicine that prevents blood clotting used: 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 reccuring in adults; to prevent venous thromboembolism VTE, the formation of blood clots in the veins in adults who are undergoing surgery to replace a hip or knee; to treat VTE and prevent VTE from recurring in children and adolescents aged less than 18 years; to prevent stroke caused by a blood clot in the brain and systemic embolism a blood clot in another organ in adults with non-valvular atrial fibrillation irregular rapid contractions of the upper chambers of the heart ; to prevent atherothrombotic events such as heart attack, stroke or death from heart disease in adults: after an acute coronary syndrome, when it is used with an antiplatelet medicine which prevents the formation of blood clots.

Acute coronary syndrome consists of conditions such as unstable angina a severe type of chest pain and heart attack; at high risk of ischaemic events problems caused by restricted blood supply who have coronary artery disease disease caused by obstructed blood supply to the heart muscle or peripheral artery disease disease caused by defective blood flow in the arteries.