A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

Inclusion Criteria:

• The patient requires, in the opinion of the Investigator, urgent surgery orprocedure and requires reversal of direct oral FXa inhibition.

• The patient requires urgent surgery or procedure within 12 hours of informedconsent.

• The patient requires urgent surgery or procedure that is expected to be associatedwith a high risk of bleeding or bleeding to occur into a critical organ.

• The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, oredoxaban) within 15 hours or more, prior to start of surgery or procedure.

• Female patients of childbearing potential must have a negative pregnancy test atScreening.

• Willingness to use highly effective methods of contraception (for male and femalepatients who are fertile).

Exclusion Criteria:

• The patient requires surgeries or procedures that have a very low chance of causingsignificant, uncontrollable bleeding, such as small skin procedures, cataractsurgery, and minor dental procedures.

• The patient has acute life-threatening bleeding at the time of Screening.

• The patient will undergo a surgery or procedure which will require the use ofheparin.

• Patient who is not expected to live for more than three months due to other healthproblems or has specifically requested not to be resuscitated if their heart stopsbeating.

• Prior to screening, the patient had either experienced low platelet count due toheparin use with or without blood clots or had a genetic condition that affectsblood clotting.

• Patient has acute decompensated heart failure, cardiogenic shock, sepsis, or septicshock at the time of Screening.

• Patient has history of heparin-induced thrombocytopenia (with or without thrombosis)or inherited coagulopathy (eg, anti-thrombin III deficiency, anti-phospholipidantibody syndrome, protein C/S deficiency, Factor V Leiden) at the time ofScreening.

• Previously diagnosed with a bleeding disorder (eg, platelet function disorder,hemophilia, Von Willebrand disease, or coagulation factor deficiency).

• Prior known hypersensitivity to andexanet alfa.

• Use of andexanet alfa 30 days prior to Screening.

• Patient diagnosed with dementia.

• Any prohibited medication as determined in the study.