A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)

Inclusion:

1. Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by
at least one of the following:

- Acute bleeding that is potentially life-threatening, OR

- Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR

- Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline
hemoglobin is available, OR

- Acute bleeding in a critical area or organ such as intraspinal, pericardial, or
intracranial.

2. If bleeding is intracranial or intraspinal, the patient must have undergone a head CT
or MRI scan demonstrating the bleeding.

3. Patient received or is believed to have received one of the following within 18 hours
prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin.

4. For patients with intracranial bleeding, there must be a reasonable expectation that
andexanet treatment will commence within 2 hours of the baseline imaging evaluation.

Exclusion:

1. The patient is scheduled to undergo surgery in less than 12 hours, with the exception
of minimally invasive surgery/procedures.

2. A patient with an intracerebral hemorrhage has any of the following:

- Glasgow coma score < 7, OR

- Intracerebral hematoma > 60 cc as assessed by CT or MRI

3. Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying
bleed.

4. Expected survival of less than 1 month

5. Recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows:
venous thromboembolism, myocardial infarction, disseminated intravascular coagulation
(DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris
hospitalization or severe peripheral vascular disease within 2 weeks prior to
screening.

6. Severe sepsis or septic shock at the time of Screening.

7. Pregnant or a lactating female.

8. Patient has received any of the following drugs or blood products within 7 days of
Screening:

- Vitamin K antagonist (VKA)

- Dabigatran

- Prothrombin Complex Concentrate products (PCC) or recombinant factor VIIa
(rfVIIa)

- Whole blood, plasma fractions

9. Treated with an investigational drug <30 days prior to Screening

10. Planned administration of PCC, fresh frozen plasma (FFP) or rfVIIa from Screening
until within 12 hours after the end of the andexanet infusion.