![]() ![]() Safety 11% of patients experienced one or more thromboembolic events and the mortality rate was 18%. Haemostatic efficacy achieved in 80% (n=342 95% CI:75-84) of patients with major bleeding at 12 hours 4,5. Efficacy Reversal of anti-FXa activity by >90% within 2-5 minutes following bolus administration in healthy volunteers (n=101), and anti-FXa activity maintained at or above placebo levels throughout the 2-hour infusion. Administration Lyophilised powder for solution, administered as an intravenous bolus followed by continuous infusion. ![]() Indication Adult patients treated with a direct FXa inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. ![]() The growing adoption of FXa inhibitors naturally leads to a corresponding need to urgently address FXa inhibitor-related bleeding. Despite their clinical benefits, FXa inhibitors are associated with major bleeding events, some of which are life-threatening 4,5.įXa inhibitor-related related major bleeds affect 2% and 4% of patients per year who have been administered apixaban and rivaroxaban 6,7, respectively and may present as an infrequent but serious complication at one or more of several organ sites including the brain, abdomen, ocular and genitourinary system 8,9.įurther, FXa inhibitor-related major bleeds are associated with an ICH-related 30-day mortality range of 45-48% 10,11. This recommendation (Class I, level of evidence A) is based on the overall clinical benefit of DOACs 3. The European Society of Cardiology (ESC) guidelines 3 have expressed a preference for direct oral anticoagulants (DOACs) over vitamin K antagonist (VKA, warfarin) in stroke prevention in patients with atrial fibrillation, especially if newly initiated. ![]()
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