The United States Food and Drug Administration (FDA) recently approved coagulation factor Xa (Andexxa) for the reversal of rivaroxaban (Xarelto) or apixaban (Eliquis) when needed due to life-threatening or uncontrolled bleeding. The drug carries a boxed warning of thromboembolic risks, ischemic risks, cardiac arrest, and sudden deaths.
The Englewood Health Pharmacy is making its limited supply available to the most critical patients in need of urgent reversal of rivaroxaban (Xarelto) or apixaban (Eliquis) related coagulopathy. The Pharmacy & Therapeutics Committee approved the addition of coagulation factor Xa (Andexxa) to the formulary with the following criteria (below). For patients presenting with rivaroxaban (Xarelto) or apixaban (Eliquis) associated GI Bleed, please consider 4-factor prothrombin complex concentrate per policy 700.51 (4F PCC, Kcentra).
Criteria for Use
Restricted to the following units:
Emergency Department, Intensive Care Unit (MSICU & CVICU), and OR.
Physicians eligible to order include:
Critical Care/Anesthesia, Emergency Medicine, and Hematology
Englewood Health approved uses:
- Spontaneous or traumatic life-threatening intracranial hemorrhage in a patient receiving apixaban or rivaroxaban in the past 24 hours.
- Exceptions may be made for the following:
- Intra-operative hemorrhage in patients who are receiving apixaban or rivaroxaban in the past 24 hours (cardiovascular / neuro surgical cases only)
- Patients with severe uncontrollable hemorrhages who were receiving apixaban or rivaroxaban in the past 24 hours and where PRBC transfusion is not an option
Englewood Health exclusions:
- Intracranial hemorrhage with GCS <7
- Major thrombotic or ischemic event within prior 2 weeks
- Exception may be made for patients with intracranial hemorrhages (Risk vs. Benefit)
- Vitamin K antagonist, prothrombin complex concentrate, or fresh frozen plasma in the past 7 days
- Dabigatran, enoxaparin, or edoxaban in the past 24 hours
If you have any questions, contact Jeffrey Nemeth, PharmD, MPA, Director of Pharmacy, or GaEun Joung, PharmD, BCPS.