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A New Option for Reversing the Anticoagulant Effect of Factor Xa Inhibitors: Andexanet alfa (Andexxa®).

著者 Rogers KC , Finks SW
Am J Med.2018 Jul 24 ; ():.
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The use of direct oral anticoagulants over traditional warfarin has increased in the United States over the past 10 years due to advantages such as ease of use, predictable pharmacokinetic response, and safety. In 2015, the FDA approved idarucizumab (Praxbind) for the reversal of the direct thrombin inhibitor, dabigatran but no reversal agent was available for oral Factor Xa (FXa) inhibitors until recently. Andexanet alfa was approved in May 2018, under the brand name Andexxa, for the reversal of two of the FXa inhibitors, apixaban and rivaroxaban, when life-threatening or uncontrolled bleeding occurs. This accelerated approval was based on change in anti FXa activity from baseline, which indicates a reversal of the anticoagulant effect. Any expanded FDA indication will be contingent on results demonstrating improved hemostasis and efficacy for reversibility of other FXa inhibitors.
PMID: 30053385 [PubMed - as supplied by publisher]
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