What are the uses of Andexanet alfa (Andexxa)?

From the Guidelines

Andexanet alfa (Andexxa) is primarily used for the urgent reversal of anticoagulation in patients taking apixaban and rivaroxaban who have acute major bleeding.

Uses of Andexanet Alfa

• Andexanet alfa is a specific reversal agent for direct Factor Xa inhibitors, including apixaban and rivaroxaban, as well as indirect Factor Xa inhibitors, such as low-molecular-weight heparin and fondaparinux 1.
• It is used to reverse anticoagulation in patients with acute major bleeding who are taking Factor Xa inhibitors, including those with gastrointestinal bleeding and intracranial hemorrhage 1.
• Andexanet alfa has also been shown to be effective in reducing anti-FXa activity in patients taking edoxaban, although this use is currently off-label 1.

Dosing and Administration

• The dosing of andexanet alfa depends on the specific Factor Xa inhibitor and the time since last dose 1.
• For rivaroxaban or apixaban, a 400 mg bolus is administered followed by a 480 mg infusion (4 mg/min) if the last intake was > 7 hours before reversal 1.
• For rivaroxaban with last intake < 7 hours before reversal or unknown recent intake, edoxaban, or enoxaparin, an 800 mg bolus is followed by a 960 mg infusion (8 mg/min) 1.

Efficacy and Safety

• Andexanet alfa has been shown to rapidly reverse the anticoagulant effect of Factor Xa inhibitors, with a high rate of hemostatic efficacy and a low rate of thrombotic events 1.
• However, larger studies are needed to confirm the safety and efficacy of andexanet alfa, particularly in comparison to other reversal agents such as prothrombin complex concentrates (PCC) 1.

From the FDA Drug Label

ANDEXXA is indicated for patients treated with rivaroxaban or apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. The uses of Andexanet alfa (Andexxa) are:

• Reversal of anticoagulation in patients treated with rivaroxaban or apixaban due to life-threatening or uncontrolled bleeding. 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 2.

From the Research

Uses of Andexanet Alfa (Andexxa)

Andexanet alfa is a specific reversal agent for factor Xa inhibitors, used to reverse the anticoagulant effect of these medications in patients with life-threatening or uncontrolled bleeding. The uses of andexanet alfa include:

• Reversal of anticoagulation in patients treated with rivaroxaban and apixaban who have life-threatening or uncontrolled bleeding 3, 4, 5
• Treatment of acute major bleeding related to apixaban and rivaroxaban 5
• Potential use in patients with life-threatening conditions, such as those requiring urgent surgery, especially neurosurgical interventions 3
• Use in patients with bleeding on edoxaban, with studies showing significant decrease in antifactor Xa activity and hemostatic efficacy similar to that observed in patients with bleeding on rivaroxaban or apixaban 6

Clinical Scenarios

Andexanet alfa may be beneficial in various clinical scenarios, including:

• Pre-treatment of urgent surgery, especially neurosurgical interventions 3
• Concomitant use of andexanet alfa and prothrombin complex concentrate 3
• Onset of bleeding more than 6 hours prior to admission 3
• Management of patients at high risk of thrombosis or recent arterial/venous thrombotic events 3

Administration and Monitoring

Andexanet alfa is administered intravenously, and its use requires close monitoring for signs and symptoms of thromboembolic events, ischemic events, and cardiac arrest 4, 5. Anticoagulation therapy should be resumed as soon as medically appropriate after andexanet alfa treatment 4, 5.