Arixtra

Product Overview

About Arixtra

Arixtra is a solution for injection in a prefilled syringe. Arixtra contains the active substance fondaparinux sodium (1.5, 2.5, 5, 7.5 or 10 mg per syringe).

What it is used for

Arixtra (1.5 and 2.5 mg strengths) is used to prevent venous thromboembolic events (VTEs, problems due to the formation of blood clots in the veins) in adults (aged 18 years or over) who are having major surgery to their legs, such as a hip or knee surgery. It can also be used in adults at high risk (because of their age or disease) when they are having abdominal surgery or are forced to stay in bed because of an acute illness. Arixtra (1.5 and 2.5 mg strengths) is also used to treat adults who have blood clots in the superficial veins of the legs (superficial venous thrombosis) but not in their deep veins (deep-vein thrombosis, DVT). At higher strengths (5, 7.5 and 10 mg), Arixtra is used to treat DVT or pulmonary embolism (PE, clot in a blood vessel supplying the lungs). The 2.5 mg strength is also used to treat adults with unstable angina (a type of chest pain that changes in severity due to reduced blood flow to the heart) or who are having a myocardial infarction (heart attack) with or without ‘ST-segment elevation’ (an abnormal reading on the electrocardiogram or ECG). The medicine can only be obtained with a prescription.

How it is used

In the prevention of VTEs, the recommended dose of Arixtra is 2.5 mg once a day by subcutaneous injection (under the skin). For patients having surgery, the first dose should be given six hours after the end of the operation. Treatment should be continued until the risk of VTE has been reduced, usually at least five to nine days after surgery. For patients who have kidney problems, Arixtra may not be suitable, or the 1.5-mg dose may be used. In the treatment of superficial-vein thrombosis, the recommended dose is 2.5 mg once a day by subcutaneous injection. Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days. In the treatment of DVT or PE, the recommended dose is 7.5 mg once a day by subcutaneous injection, usually for seven days. The dose may be adjusted depending on body weight. For patients with unstable angina or myocardial infarction, the recommended dose is 2.5 mg once daily by subcutaneous injection, but the first dose is given intravenously (into a vein) through an existing line or as an infusion (drip) in patients with ST-segment elevation. Treatment should be started as soon as possible after diagnosis and continued for up to eight days or until the patient is discharged from hospital. Arixtra is not recommended in patients who are about to undergo certain types of operations to unblock the heart’s blood vessels.

How it works

Blood clotting can be a problem when blood flow is disturbed in any way. Arixtra is an anticoagulant: it prevents the blood from coagulating (clotting). The active ingredient in Arixtra, fondaparinux sodium, stops one of the substances (factors) that are involved in the clotting of blood, factor Xa. When this is blocked, no thrombin (another factor) can be produced, and no clot can be formed. By using Arixtra after surgery, the risk of a blood clot forming is greatly reduced. By reducing blood clots, Arixtra can also help the flow of blood to the heart to be maintained in patients with angina or who are having a heart attack.

Active substance: fondaparinux sodium

Source: EMA EPAR