9. Centers for Medicare & Medicaid Services (CMS). Full study report of andexanet alfa for bleeding associated with factor Xa inhibitors. Connolly SJ, Crowther M, Eikelboom JW, et al. Emergence of new oral antithrombotics: a critical appraisal of their clinical potential. Direct thrombin inhibitors and factor Xa inhibitors in patients with cerebrovascular disease. Morales-Vidal S, Schneck MJ, Flaster M, Biller J. Andexanet alfa for the reversal of factor Xa inhibitor activity. 5. Siegal DM, Curnutte JT, Connolly SJ, 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. The 2018 European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist oral anticoagulants in patients with atrial fibrillation. 3. Steffel J, Verhamme P, Potpara TS, et al. 2020 ACC expert consensus decision pathway on management of bleeding in patients on oral anticoagulants: a report of the American College of Cardiology Solution Set Oversight Committee. Tomaselli GF, Mahaffey KW, Cuker A, et al. Boston, MA: Alexion Pharmaceuticals, Inc.

Major bleeding with hemodynamic instability-gastrointestinal, retroperitoneal, genitourinary tract bleedġ. ANDEXXA ® (coagulation factor Xa (recombinant), inactivated-zhzo).Major trauma-blunt or penetrating injury.Bleeding at a critical site-intraocular, pericardial, intraspinal, intra-articular.Intracranial hemorrhage-intracerebral, subdural, subarachnoid.Life-threatening or uncontrolled factor Xa (FXa) inhibitor–related bleeds can occur in several sites 2-4: *ANDEXXA has not been shown to be effective for, and is not indicated for, the treatment of bleeding related to any factor Xa (FXa) inhibitors other than apixaban or rivaroxaban. Continued approval for this indication may be contingent upon the results of studies that demonstrate an improvement in hemostasis in patients. An improvement in hemostasis has not been established. This indication is approved under accelerated approval based on the change from baseline in anti-factor Xa (FXa) activity in healthy volunteers. 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.

Andexxa mechanism of action