Drug Detail:Factor xa (recombinant), inactivated-zhzo (monograph) (Andexxa)
Drug Class:
Usual Adult Dose for Reversal of Anticoagulation
Reversal of Apixaban Anticoagulation:
Last apixaban dose was 5 mg or less: 400 mg IV bolus at a target rate of 30 mg/min, followed within 2 minutes later by 4 mg/min IV infusion for up to 120 minutes
Last apixaban dose was greater than 5 mg (or unknown) and was administered less than 8 hours (or unknown) ago: 800 mg IV bolus at a target rate of 30 mg/min, followed within 2 minutes later by 8 mg/min IV infusion for up to 120 minutes
Last apixaban dose was greater than 5 mg (or unknown) and was administered at least 8 hours ago: 400 mg IV bolus at a target rate of 30 mg/min, followed within 2 minutes later by 4 mg/min IV infusion for up to 120 minutes
Comments: Resume anticoagulant therapy as soon as medically appropriate following treatment with this drug.
Use: Reversal of anticoagulation in patients who have been treated with apixaban and are experiencing life-threatening or uncontrolled bleeding.
Reversal of Rivaroxaban Anticoagulation:
Last rivaroxaban dose was 10 mg or less: 400 mg IV bolus at a target rate of 30 mg/min, followed within 2 minutes later by 4 mg/min IV infusion for up to 120 minutes
Last rivaroxaban dose was greater than 10 mg (or unknown) and was administered less than 8 hours (or unknown) ago: 800 mg IV bolus at a target rate of 30 mg/min, followed within 2 minutes later by 8 mg/min IV infusion for up to 120 minutes
Last rivaroxaban dose was greater than 5 mg (or unknown) and was administered at least 8 hours ago: 400 mg IV bolus at a target rate of 30 mg/min, followed within 2 minutes later by 4 mg/min IV infusion for up to 120 minutes
Comments: Resume anticoagulant therapy as soon as medically appropriate following treatment with this drug.
Use: Reversal of anticoagulation in patients who have been treated with rivaroxaban and are experiencing life-threatening or uncontrolled bleeding.
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
US BOXED WARNING:
- THROMBOEMBOLIC RISKS, ISCHEMIC RISKS, CARDIAC ARREST, AND SUDDEN DEATHS: Treatment with this drug has been associated with serious and life-threatening adverse events, including: arterial and venous thromboembolic events; ischemic events, including myocardial infarction and ischemic stroke; cardiac arrest; sudden deaths. Monitor for thromboembolic events and initiate anticoagulation when medically appropriate. Monitor for symptoms and signs that precede cardiac arrest and provide treatment as needed.
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice: Administer IV using a 0.2 or 0.22 micron in-line polyethersulfone or equivalent low protein-binding filter.
Storage requirements:
- Unopened vials should be refrigerated at 2C to 8C (36F to 46F). Do not freeze.
- When reconstituted in vials, may be stored at room temperature for up to 8 hours, or at 2C to 8C for up to 24 hours.
- When reconstituted in IV bags, may be stored at room temperature for up to 8 hours, or at 2C to 8C for up to 16 hours.
Reconstitution/preparation techniques: The manufacturer product information should be consulted.
Monitoring:
- Cardiovascular: Signs and symptoms of arterial and venous thromboembolic events, ischemic events, and cardiac arrest.