ANDEXANET ALFA

Other

Brand names: ANDEXXA

Intravenous

Mechanism of Action

12.1 Mechanism of Action Coagulation factor Xa (recombinant), inactivated-zhzo exerts its procoagulant effect by binding and sequestering the FXa inhibitors, rivaroxaban and apixaban. Another observed procoagulant effect of the ANDEXXA protein is its ability to bind to, and inhibit the activity of, Tissue Factor Pathway Inhibitor (TFPI). Inhibition of TFPI activity can increase tissue factor (TF)-initiated thrombin generation.

Indications

1 INDICATIONS AND USAGE ANDEXXA is indicated for patients treated with rivaroxaban or apixaban

inactivated-zhzo) is a recombinant modified human factor Xa (FXa) protein indicated for patients treated with rivaroxaban or apixaban

14 ) 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 ) Limitations of Use ANDEXXA has not been shown to be effective for

and is not indicated for

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS • Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA
1 Thromboembolic and Ischemic Risks The thromboembolic and ischemic risks were assessed in 419 bleeding -patients in the ANNEXA-4 study who received ANDEXXA and were treated with apixaban or rivaroxaban
To reduce thromboembolic risk, resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA [ see Dosage and Administration (2
2 Unresponsiveness to Unfractionated Heparin Unresponsiveness to unfractionated heparin leading to non-prolongation of activated clotting times and serious thrombotic events has occurred following ANDEXXA administration

Known Side Effects

0 documented side effects by frequency

No structured side effect data available.

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Formulations

Dosage Forms

Tablet

Route

Intravenous