Prothrombin complex concentrates (PCCs) are frequently used off label for the management of factor Xa inhibitor-associated major bleeding.
In 2018, accelerated approval was granted for andexanet alfa, a specific factor Xa inhibitor reversal agent, for reversal of apixaban and rivaroxaban in the setting of life-threatening or uncontrolled bleeding.
Following accelerated approval, some clinical practice guidelines were updated to include recommendations for andexanet alfa preferentially over PCCs for reversal of life-threatening or uncontrolled bleeding due to rivaroxaban or apixaban. Other guidelines stated no preference of...
Prothrombin complex concentrates (PCCs) are frequently used off label for the management of factor Xa inhibitor-associated major bleeding.
In 2018, accelerated approval was granted for andexanet alfa, a specific factor Xa inhibitor reversal agent, for reversal of apixaban and rivaroxaban in the setting of life-threatening or uncontrolled bleeding.
Following accelerated approval, some clinical practice guidelines were updated to include recommendations for andexanet alfa preferentially over PCCs for reversal of life-threatening or uncontrolled bleeding due to rivaroxaban or apixaban. Other guidelines stated no preference of andexanet alfa over PCC.
In 2020, Vizient convened an expert panel to critically appraise the literature and provide consensus-based, expert opinions on the utilization of pharmacological reversal agents for factor Xa-related major bleeding. Since then, the body of literature evaluating these agents has expanded to include a randomized controlled trial, ANNEXa-I, the results of which were submitted to the US Food and Drug Administration to convert the approval of andexanet alfa from accelerated to full approval.
Dr. Lisa Baumann-Kreuziger, Associate Professor of Hematology and Oncology, Medical College of Wisconsin and medical director of the Antithrombotic Therapy Management Program at Froedtert Health discusses the current status of management of factor Xa inhibitor-associated major bleeding with Dr. Kerry Schwarz, Senior Clinical Manager of Evidence-Based Medicine and Outcomes with the Vizient Center for Pharmacy Practice Excellence, and your program host.
Guest speakers:
Liza Baumann-Kreuziger, MD, MS
Investigator, Blood Research Institute, Versiti
Associate Professor of Hematology and Oncology, Medical College of Wisconsin
Medical Director, Antithrombotic Therapy Management Program at Froedtert Health
Host:
Kerry Schwarz, Pharm.D, MPH
Senior Clinical Manager of Evidence-Based Medicine and Outcomes
Vizient Center for Pharmacy Practice Excellence
Show Notes:
[02:25-04:26] The current state of hemostatic management in the setting of factor Xa inhibitor-related major bleeding
[04:27- 05:35] Limitations of available evidence making clinical practice and formulary decision making so challenging
[05:35 – 10:52] Publication of the first randomized controlled trial, ANNEXa-I, comparing andexanet alfa to usual care
[10:52-14:49] Meeting of the FDA advisory committee and subsequent complete response letter
[14:50-16:45] How we can approach clinical management of patients and formulary decision-making in the current state
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