These highlights do not include all the information needed to use ANDEXXA safely and effectively. See Full Prescribing Information for ANDEXXA.
ANDEXXA � (coagulation factor Xa (recombinant), inactivated-zhzo)
Lyophilized Powder for Solution For Intravenous Injection
Initial U.S. Approval: 2018
WARNING: THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING
Treatment with ANDEXXA has been associated with serious and life-threatening adverse events, including: (5.1)
Arterial and venous thromboembolic events
Ischemic events, including myocardial infarction and ischemic stroke
Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
INDICATIONS AND USAGE
ANDEXXA, coagulation factor Xa (recombinant), inactivated-zhzo is a recombinant modified human Factor Xa (FXa) protein indicated for patients treated with rivaroxaban and apixaban, when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. (1)
This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. An improvement in hemostasis has not been established. Continued approval for this indication may be contingent upon the results of studies to demonstrate an improvement in hemostasis in patients. (1,14)
Limitation 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 and rivaroxaban. (1)
DOSAGE AND ADMINISTRATION
For intravenous use only.
Dose ANDEXXA based on the specific FXa inhibitor, dose of FXa inhibitor, and time since the patient's last dose of FXa inhibitor. (2)
Administer as an intravenous (IV) bolus, with a target rate of 30 mg/min, followed by continuous infusion for up to 120 minutes.
There are two dosing regimens:
Dose* Initial IV Bolus Follow-On IV Infusion
* The safety and effectiveness of more than one dose have not been evaluated.
Low Dose 400 mg at a target rate of 30 mg/min 4 mg/min for up to 120 minutes
High Dose 800 mg at a target rate of 30 mg/min 8 mg/min for up to 120 minutes
DOSAGE FORMS AND STRENGTHS
ANDEXXA is available as a lyophilized powder in single-use vials of 100 mg of coagulation factor Xa (recombinant), inactivated-zhzo. (3)
WARNINGS AND PRECAUTIONS
Arterial and venous thromboembolic events, ischemic events, and cardiac events, including sudden death, have occurred during treatment with ANDEXXA. Resume anticoagulant therapy as soon as medically appropriate following treatment with ANDEXXA. (5.1)
Re-elevation or incomplete reversal of anticoagulant activity can occur. (5.2)
The most common adverse reactions (? 5%) in patients receiving ANDEXXA were urinary tract infections and pneumonia. (6.1)
The most common adverse reactions (? 3%) in healthy volunteers treated with ANDEXXA were infusion-related reactions.
To report SUSPECTED ADVERSE REACTIONS, contact Portola Pharmaceuticals, Inc. at 1-866-777-5947 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.