The company is seeking conditional approval in patients treated with a Factor Xa inhibitor such as Johnson & Johnson/Bayer’s Xarelto (rivaraxoban), when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery.Įurope’s CHMP has begun its standard 210-day review period. Use: Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients greater than 40 years old undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease.Portola has said European regulators are to review its anticoagulant antidote, IndexXa (andexanet alfa), just days after the US regulator rejected the drug.Ĭalifornia-based Portola said the European Medicines Agency had accepted its filing for the Factor Xa inhibitor antidote. Use: Low-dose regimen for prevention of postoperative deep venous thrombosis and pulmonary embolism in patients greater than 40 years old undergoing major abdominothoracic surgery or who, for other reasons, are at risk of developing thromboembolic disease. Usual Adult Dose for Prevention of Thromboembolism in Atrial Fibrillation
Usual Adult Dose for Deep Vein Thrombosis - Prophylaxis Administer by deep subcutaneous (intrafat, e.g., above the iliac crest or abdominal fat layer, arm, or thigh) injection with a fine (25 to 26 gauge) needle to minimize tissue trauma.Prophylaxis and treatment of peripheral arterial embolism.ĥ000 units subcutaneously 2 hours before surgery and 5000 units subcutaneously every 8 to 12 hours thereafter for 7 days or until the patient is ambulatory, whichever is longer.Treatment of acute and chronic consumption coagulopathies (disseminated intravascular coagulation).Prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation.Prophylaxis and treatment of venous thrombosis and pulmonary embolism.Dosage and administration must be individualized according to the results of suitable laboratory tests.Consult the latest guidelines regarding duration and intensity of anticoagulation for the indicated conditions.Recommended doses are based on a 68 kg patient.Maintenance dose: 5000 to 10,000 units IV every 4 to 6 hoursģ33 units/kg subcutaneously followed by 250 units/kg subcutaneously every 12 hours the following dosage regimen has also been recommended: 5000 units by IV injection followed by 10,000 to 20,000 units subcutaneously, and then 8000 to 10,000 units subcutaneously every 8 hours or 15,000 to 20,000 units subcutaneously every 12 hours.Maintenance dose: 20,000 to 40,000 units per 24 hours by continuous IV infusion.Initial dose: 5000 units by IV injection.The manufacturer provides the following dosing guidelines based on clinical experience: Usual Adult Dose for Deep Vein Thrombosis Patency Maintenance of Indwelling Intravenous Devices.Prevention of Thromboembolism in Atrial Fibrillation.
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