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Presentation Details
| Quantifying Inappropriate Andexanet Alfa Use Prior to Institutional Policy Revision: A Review of Fifty Consecutive Administrations Alifya Altaf Lokhandwala, Filip Sadurski, Rohit Sharma, Monika Onusseit, Ellen Arrington, Sarah Benmir, Moosa Alhoda, Abdulrahman Alyounes Alayoub, Mishel Papali, Matthew Basciotta. Department of Medicine, Salem Hospital, Mass General Brigham, Salem, MA, USA |
Abstract
Background: Andexanet alfa (Andexxa) is the only FDA-approved reversal agent for factor Xa inhibitors and is associated with a measurable risk of thrombotic events, especially when used outside recommended criteria. Its indication profile is narrow and dose selection depends on an accurate reconstruction of the last anticoagulant dose and timing. Deviations from these criteria can lead to avoidable complications and excess cost. Objective: Under the prior institutional policy, Andexxa could be ordered by ED, inpatient, or surgical attendings (or supervised trainees), with haematology consultation mandated only for selected scenarios such as subacute CNS bleeding, nonoperative trauma, urgent surgery, or reversal of non-apixaban/rivaroxaban agents. Given the variability this allowed, we evaluated all administrations to quantify inappropriate use, characterize common error patterns, and identify specific targets for policy redesign. Methods:
We performed a retrospective review of 50 consecutive Andexxa administrations between July 2024 and September 2025. Appropriateness was determined using institutional and guideline-based criteria: (1) documented factor Xa inhibitor ingestion within 18 hours, (2) presence of life-threatening or hemodynamically significant bleeding, (3) accurate low- vs high-dose selection according to agent, dose, and timing, (4) absence of recent 4-factor PCC, and (5) correct bolus and infusion administration parameters. Cases with incomplete last-dose data were classified as “questionable.” Pharmacist notes, ED/ICU documentation, and imaging were reviewed to identify discordant use and associated harm. Results:
Of the 50 administrations, 32 (64%) were appropriate, 14 (28%) inappropriate, and 4 (8%) questionable. Inappropriate cases most commonly involved incorrect dose selection (8, 57%) and administration outside the 18-hour window (4, 29%); additional errors included recent 4F-PCC exposure (1, 7%) and infusion-rate deviation (1, 7%). Failure to verify last-dose timing contributed to multiple questionable classifications. Three significant neurologic events occurred. One patient receiving an incorrect high-dose regimen developed splenic and renal infarcts. A second patient treated outside the 18-hour window developed acute neurologic deficits within one hour; imaging showed diffuse bilateral multifocal infarcts, leading to comfort-focused care. A third patient receiving an inappropriate high-dose regimen was later found to have multiple supratentorial acute infarcts, with left-sided weakness identified two days later. Conclusions:
More than one-third of pre-policy Andexxa administrations were questionable, driven largely by preventable dosing and timing deviations. These findings directly shaped the revised institutional policy, which now: (1) restricts Andexxa use to explicit life-threatening criteria with detailed critical-site and hemodynamic definitions; (2) requires pharmacist review and hematology attending approval for any non-criteria case, perioperative use, >18-hour timing, or prior PCC exposure; and (3) designates 4F-PCC as the preferred strategy in several scenarios, including pericardial tamponade and non-critical-site bleeding without hemodynamic compromise. The frequency of discordant use and the presence of multiple adverse events highlight the need for strict governance, real-time decision support, and continuous monitoring to ensure safe and evidence-based use of Andexxa.
No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.
We performed a retrospective review of 50 consecutive Andexxa administrations between July 2024 and September 2025. Appropriateness was determined using institutional and guideline-based criteria: (1) documented factor Xa inhibitor ingestion within 18 hours, (2) presence of life-threatening or hemodynamically significant bleeding, (3) accurate low- vs high-dose selection according to agent, dose, and timing, (4) absence of recent 4-factor PCC, and (5) correct bolus and infusion administration parameters. Cases with incomplete last-dose data were classified as “questionable.” Pharmacist notes, ED/ICU documentation, and imaging were reviewed to identify discordant use and associated harm. Results:
Of the 50 administrations, 32 (64%) were appropriate, 14 (28%) inappropriate, and 4 (8%) questionable. Inappropriate cases most commonly involved incorrect dose selection (8, 57%) and administration outside the 18-hour window (4, 29%); additional errors included recent 4F-PCC exposure (1, 7%) and infusion-rate deviation (1, 7%). Failure to verify last-dose timing contributed to multiple questionable classifications. Three significant neurologic events occurred. One patient receiving an incorrect high-dose regimen developed splenic and renal infarcts. A second patient treated outside the 18-hour window developed acute neurologic deficits within one hour; imaging showed diffuse bilateral multifocal infarcts, leading to comfort-focused care. A third patient receiving an inappropriate high-dose regimen was later found to have multiple supratentorial acute infarcts, with left-sided weakness identified two days later. Conclusions:
More than one-third of pre-policy Andexxa administrations were questionable, driven largely by preventable dosing and timing deviations. These findings directly shaped the revised institutional policy, which now: (1) restricts Andexxa use to explicit life-threatening criteria with detailed critical-site and hemodynamic definitions; (2) requires pharmacist review and hematology attending approval for any non-criteria case, perioperative use, >18-hour timing, or prior PCC exposure; and (3) designates 4F-PCC as the preferred strategy in several scenarios, including pericardial tamponade and non-critical-site bleeding without hemodynamic compromise. The frequency of discordant use and the presence of multiple adverse events highlight the need for strict governance, real-time decision support, and continuous monitoring to ensure safe and evidence-based use of Andexxa.
No part of this publication may be reproduced, distributed, or transmitted in any form or by any means, including photocopying, recording, or other electronic or mechanical methods, without the prior written permission of the author.