5 These results largely echo the preliminary trial findings, demonstrating that andexanet alfa produces a significant reduction in anti-factor Xa activity. Since the previous FAQ, the final results from ANNEXA-4 have been released (Table). However, andexanet alfa’s ability to improve hemostasis remains to be established, according to the prescribing information. 4 Most patients also achieved excellent or good hemostasis after receiving andexanet alfa. 3 Preliminary results from a single-arm trial in factor Xa inhibitor-associated acute major bleeding (ANNEXA-4) showed that andexanet alfa decreases anti-factor Xa activity in this patient population. It is currently approved for the reversal of anticoagulation in patients treated with rivaroxaban or apixaban when reversal is necessary due to life-threatening or uncontrolled bleeding.Īndexanet alfa was approved through an accelerated approval pathway based on its demonstrated ability to produce changes in anti-factor Xa activity in healthy volunteers. 3 It has also been shown to inhibit tissue factor pathway inhibitor activity, which increases thrombin generation and further promotes coagulation. Andexanet alfa is a recombinant modified human coagulation factor Xa protein that binds and sequesters apixaban and rivaroxaban, exerting a procoagulant effect. Before the approval of andexanet alfa, no specific reversal agents were available for factor Xa inhibitors instead, inactivated prothrombin complex concentrates (PCCs) were used off-label as first-line agents for factor Xa inhibitor reversal.
2 Like all anticoagulants, these medications carry a risk of bleeding. The purpose of this article is to describe the updated literature for andexanet alfa in the setting of factor Xa inhibitor reversal.įactor Xa inhibitors (rivaroxaban, apixaban, edoxaban, and betrixaban) are commonly used for anticoagulation. Since the publication of this review, additional studies and recommendations for andexanet alfa use have been published. In August 2018, the UIC Drug Information Group reviewed the literature related to the use of andexanet alfa for the reversal of factor Xa inhibitors.
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