The Unknowns of Anti-factor Xa Reversal: The Experts Weigh In
Aug 10th, 2021 by Vizient
The ability to chronically anticoagulate a patient has prevented significant morbidity and mortality from thromboembolic events. Over time, our anticoagulation choices for oral use have evolved, but the need for reversal agents still persist. Two Vizient pharmaceutical experts weigh in on the clinical implications and latest standings of reversal agents.
Stacy Lauderdale, PharmD, BCPS
Senior Director, Drug Information
David Reardon, PharmD, BCPS
Senior Director, Pharmacy Networks
Northeast Purchasing Coalition (NPC)
Pharmacy Member Services
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
[01:15] Warfarin has been the cornerstone of oral anticoagulant therapy since the 1950s but has many limitations including causing bleeding and thrombosis if not managed properly.
[01:45] In 2011, a new class of oral factor 10a inhibitors was approved which drastically changed the oral anticoagulant landscape.
[01:45] Most common: apixaban and rivaroxaban. They have fewer drug-drug interactions and fewer drug-food interactions than Warfarin.
[02:26] In May 2018, FDA approved andexanet alfa. It has an accelerated biologic license conditional approval based on some surrogate markers in the trials. Clinical trials are underway.
[03:41] In January 2021, Vizient published a consensus-based document regarding the expert task force’s findings on how to manage the pharmacological reversal agents for factor 10a inhibitor-related bleeding.
[05:27] What the literature says regarding the factor 10a inhibitors
[06:53] Task force compared the clinical effectiveness of andexanet versus pro-hemostatic agents using the ICER Evidence rating Matrix tool.
[08:37] Task force recommends that institutions have an anticoagulation reversal policy. The Joint Commission National Patient Safety Goal for anticoagulation therapy provides guidance for that organizations should have on hand.
[09:06] Policy should address standard of care, radiographical and laboratory studies, as well as appropriate pharmacological interventions. Anticoagulation reversal agents will not correct hemodynamic instability, so you’ll need to start other therapies.
[09:35] Pharmacists can drive the protocols and adoption of prothrombin complex concentrates
[10:43] Expert panel is in consensus that use of pro-hemostatic agents for reversal of a factor 10a inhibitor-related bleed is ethically and legally justified, despite the fact that andexanet is FDA approved for it.
[12:42] Budgetary considerations with the two agents, the prothrombin complex concentrates or PCCs and andexanet alfa
Links | Resources:
Consensus statement on use of reversal agents for factor Xa inhibitor – related bleeding, December 2020, Vizient Click here