![]() ![]() Sustained normalization of thrombin generation for ≈2 hours and sustained decrease in unbound anticoagulant (maximum ≈80%) for up to ≈4 hours following completion of andexanet alfa administration, compared with placebo, were observed when andexanet was administered as a bolus or as a bolus followed by continuous infusion. The stoichiometric ratios of andexanet alfa:total anticoagulant at maximum reversal of anti-FXa activity ranged from 1:1 to 1.3:1 for rivaroxaban and 1.41:1 to 2.58:1 for edoxaban. 05), respectively, compared with placebo. Within 2 minutes after bolus, anti-FXa activity decreased significantly, with maximum decreases of ≈93% ( P <. Andexanet alfa rapidly and effectively reversed anticoagulation with both rivaroxaban and edoxaban. In two phase 2, randomized, double-blind, placebo-controlled, single-center studies, different regimens of andexanet alfa were administered to healthy volunteers after therapeutic anticoagulation with rivaroxaban or edoxaban, and multiple anticoagulation reversal and safety end points were evaluated. ![]() Andexanet alfa is a recombinant modified human FXa lacking enzymatic activity, developed for reversal of FXa inhibitor–induced anticoagulation. As with any anticoagulant, factor Xa (FXa) inhibitors are associated with a risk of major bleeding. ![]()
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