Postmarketing Experience The following adverse reactions have been identified during post-approval use of Arixtra. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In the postmarketing experience, epidural or spinal hematoma has been reported in association with the use of Arixtra by subcutaneous SC injection [see Warnings and Precautions 5. Occurrences of thrombocytopenia with thrombosis that manifested similar to heparin-induced thrombocytopenia have been reported in the postmarketing experience and cases of elevated aPTT temporally associated with bleeding events have been reported following administration of Arixtra with or without concomitant administration of other anticoagulants [see Warnings and Precautions 5. In addition, Arixtra neither influenced the pharmacodynamics of warfarin, acetylsalicylic acid, piroxicam, and digoxin, nor the pharmacokinetics of digoxin at steady state.
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This medicine is authorised for use in the European Union. It explains how the Committee for Medicinal Products for Human Use CHMP assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Arixtra. Expand section Collapse section What is Arixtra? Arixtra is a solution for injection in a prefilled syringe.
Arixtra contains the active substance fondaparinux sodium 1. What is Arixtra used for? Arixtra 1. 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. At higher strengths 5, 7. The 2. The medicine can only be obtained with a prescription.
How is Arixtra used? In the prevention of VTEs, the recommended dose of Arixtra is 2. 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. In the treatment of superficial-vein thrombosis, the recommended dose is 2. Treatment should be started as soon as possible following exclusion of DVT, and should be continued for between 30 and 45 days. The dose may be adjusted depending on body weight. For patients with unstable angina or myocardial infarction, the recommended dose is 2. 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.
For more information, see the summary of product characteristics also part of the EPAR. How does Arixtra work? 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.
How has Arixtra been studied? Arixtra has been studied for the prevention of and in the treatment of VTE. In the prevention studies, Arixtra was compared with other anticoagulants: enoxaparin in hip or knee surgery; over 8, patients or dalteparin in abdominal surgery; 2, patients. It was also compared with placebo a dummy treatment when looking at patients with an acute illness patients and patients treated for an additional 24 days following hip-fracture surgery patients.
In all studies, the main measure of effectiveness was the overall rate of thrombotic events problems caused by blood clots. In the treatment of superficial-vein thrombosis, Arixtra was compared with placebo in one study of 3, patients with superficial-vein thrombosis of the legs, without DVT. The main measure of effectiveness of this study was the overall occurrence of VTE or death. Arixtra has also been studied in two main studies of patients with unstable angina or myocardial infarction.
The first compared the effects of Arixtra with those of enoxaparin in over 20, patients with unstable angina or myocardial infarction without ST-segment elevation, and the second compared Arixtra with standard care unfractionated heparin in eligible patients, or placebo in over 12, patients with myocardial infarction with ST segment elevation. What benefit has Arixtra shown during the studies? The overall rate of thrombotic events in patients treated with Arixtra was significantly less than in patients treated with placebo or enoxaparin for patients undergoing leg surgery , and was similar to that seen with enoxaparin treatment of DVT , dalteparin or unfractionated heparin.
Arixtra was more effective than placebo in reducing the overall occurrence of VTE or death in patients with superficial-vein thrombosis. While there was one VTE or death for every patients taking Arixtra, there were six for every hundred taking placebo. However, these results were insufficient to show whether Arixtra was more effective than unfractionated heparin or not. What is the risk associated with Arixtra? As with other anticoagulant medicines, the most common side effect of Arixtra is bleeding.
For the full list of all side effects reported with Arixtra, see the package leaflet. Arixtra should not be used in people who may be hypersensitive allergic to fondaparinux sodium or any of the other ingredients, who might be bleeding already, who have acute bacterial endocarditis an infection of the heart or have severe kidney problems.
For the full list of restrictions, see the package leaflet. Why has Arixtra been approved? Other information about Arixtra The European Commission granted a marketing authorisation valid throughout the European Union for Arixtra on 21 March The marketing authorisation is valid for an unlimited period. The marketing-authorisation holder is Glaxo Group Ltd.
The activity of fondaparinux sodium is measured based on plasma drug concentrations quantified by anti-factor Informatino activity using fondaparinux as the calibrator. Bounameaux, H, Perneger T. Postoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: Anticoagulation results from rapid inhibition of factor Xa by antithrombin III bound to fondaparinux about fold greater than innate activity. A synthetic pentasaccharide for the ariixtra of deep- vein thrombosis. Binds selectively to antithrombin III; unable to inactivate thrombin. Bridgewater, NJ; Jul.