following bolus and sustained throughout the 2-hour IV infusion*1

ANDEXXA® is the first and only FDA-approved specific reversal agent for ELIQUIS® (apixaban) or XARELTO® (rivaroxaban) related life-threatening or uncontrolled bleeding.1

*ANNEXA-A and ANNEXA-R were two Phase 3 studies designed to establish the efficacy and safety of ANDEXXA for the reversal of anticoagulation with apixaban or rivaroxaban in older, healthy volunteers vs placebo. The primary endpoint of both studies was mean percent change in anti-FXa activity, from baseline to nadir, for the low-dose and high-dose regimens of bolus followed by continuous infusion. In ANNEXA-A and ANNEXA-R, 23/31 and 26/39 patients received ANDEXXA respectively.1

ANDEXXA (coagulation factor Xa (recombinant), inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.1

This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients.1

Limitations of Use: ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.1

FXa inhibitor–related major bleeds can occur in several sites2-4


Intracranial Hemorrhage
intracerebral, subdural, subarachnoid


Bleeding at a Critical Site
intraocular, pericardial, intraspinal, intra-articular


Major Trauma
blunt or penetrating injury


Major Bleeding with Hemodynamic Instability
gastrointestinal, retroperitoneal, genitourinary tract bleed

Facts about life-threatening bleeding events

There is an urgent need for a specific reversal agent for FXa inhibitor-treated patients hospitalized with a major bleed.5,6

Bleeding admissions rise as oral FXa inhibitor use grows7-9†



patients each day were hospitalized with an apixaban- or rivaroxaban-related bleed in 20189


patients die each day following hospitalization from apixaban- or rivaroxaban-related bleeds9-11

Rolling 12-month data calculation.
From December 31, 2017 to December 31, 2018.

1. Andexxa (prescribing information). Boston, MA: Alexion Pharmaceuticals, Inc.; 2021. 2. Tomaselli GF, Mahaffey KW, Cuker A, et al. 2017 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Task Force on expert consensus decision pathways. J Am Coll Cardiol. 2017;70(24):3042-3067. 3. Steffel J, Verhamme P, Potpara TS, et al; for the ESC Scientific Document Group. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. Eur Heart J. 2018;39(16):1330-1393. 4. Raval AN, Cigarroa JE, Chung MK, et al. Management of patients on non-vitamin K antagonist oral anticoagulants in the acute care and periprocedural setting: a scientific statement from the American Heart Association. Circulation. 2017;135(10):e604-e633. 5. Milling TJ Jr, Clark CL, Feronti C, et al. Management of factor Xa inhibitor-associated life-threatening major hemorrhage: a retrospective multi-center analysis. Am J Emerg Med. 2018;36(3):396-402. 6. Kaatz S, Bhansali H, Gibbs J, Lavender R, Mahan CE, Paje DG. Reversing factor Xa inhibitors–clinical utility of andexanet alfa. J Blood Med. 2017;8:141-149. 7. Truven Bleeding Events Report: Commercial, Medicare, & Medicaid Populations. August 16, 2016. 8. Truven Health Analytics, DOAC Market Data Report. Data month ending November 2018. 9. Truven Health Analytics, DOAC Market Data Report. Data month ending September 2019. 10. Piccini JP, Garg J, Patel MR, et al; for the ROCKET AF Investigators. Management of major bleeding events in patients treated with rivaroxaban vs. warfarin: results from the ROCKET AF trial. Eur Heart J. 2014;35(28):1873-1880. 11. Held C, Hylek EM, Alexander JH, et al. Clinical outcomes and management associated with major bleeding in patients with atrial fibrillation treated with apixaban or warfarin: insights from the ARISTOTLE trial. Eur Heart J. 2015;36(20):1264-1272.