M.It is given by injection just under the skin or into a vein.Journal of thrombosis and haemostasis : JTH.Cochrane Central Register of Controlled Trials (CENTRAL).Information DOI of original publication: Copy DOI Database: AnXa is well‐tolerated and is a promising, universal antidote for both direct and indirect fXa inhibitors. Conclusion: In conclusion, results from this ongoing study demonstrate that AnXa is able to rapidly reverse the anticoagulant effects of the ATIII‐dependent fXa inhibitor enoxaparin, as assessed by PD markers. One subject discontinued prior to receiving AnXa due to rash from enoxaparin. Adverse events related to AnXa or placebo occurring in > 10% of subjects were infusion‐related reactions (n = 4, all mild). AnXa was well tolerated (no thrombotic events, serious, or severe adverse events). The nearly complete reversal of anti‐FXa activity and restoration of normal thrombin generation was maintained for 2‐3 h after bolus administration of AnXa. Immediately after bolus administration (2 min), anti‐FXa activity was reduced to 0.12‐0.13 IU mL‐1 (below the established enoxaparin therapeutic anticoagulation threshold) and inhibition of thrombin generation was reversed to normal baseline levels.

Results: From two dose cohorts (210 and 420 mg), mean anti‐FXa activity at 3 h after the last enoxaparin dose (Ĭmax: just prior to AnXa administration) on day 6 was 0.36 +/‐ 0.08 IU mL‐1 (mean +/‐ SD). Methods: Enoxaparin was administered at 40 mg SQ QD for 6 days to steady state and AnXa or vehicle was administered as an IV bolus (30 mg min‐1) utilizing a 6:3 ratio of AnXa to placebo‐treated subjects. Here we report the first demonstration in healthy subjects that AnXa can rapidly reverse enoxaparin‐induced anti‐FXa activity and restore normal hemostatic mechanisms. AnXa is catalytically inactive but retains high‐affinity binding to direct FXa inhibitors as well as ATIII‐dependent inhibitors such as enoxaparin. Objectives: Andexanet‐alfa (AnXa) is a modified, recombinant human factor Xa (FXa) molecule developed as a specific antidote to reverse the anticoagulant activity of FXa inhibitors during epiodes of serious uncontrolled bleeding or before urgent/emergent surgery.

Enoxaparin antidote