Coagulation Factor Xa Dosage
Medically reviewed by Drugs.com. Last updated on Aug 16, 2023.
Applies to the following strengths: recombinant, inactivated-zhzo 200 mg; recombinant, inactivated-zhzo 100 mg
Usual Adult Dose for:
Additional dosage information:
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
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 10 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:
- The safety and efficacy of an additional dose has not been established.
- Anticoagulant therapy should be resumed as soon as medically appropriate following treatment with this drug.
- This indication is approved under accelerated approval based on the change from baseline in anti-FXa activity in healthy volunteers. Continued approval may depend on the results of studies that demonstrate an improvement in hemostasis.
Use: Reversal of anticoagulation in patients who have been treated with apixaban or 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, and 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:
- Prior to administration, carefully inspect for particulate matter and discoloration.
- Administer IV using a 0.2 or 0.22 micron in-line polyether sulfone or equivalent low protein-binding filter.
Storage requirements:
- Unopened vials should be refrigerated at 2 C to 8 C (36 F to 46 F). Do not freeze.
- When reconstituted in vials, may be stored at room temperature for up to 8 hours, or at 2 C to 8 C for up to 24 hours.
- When reconstituted in IV bags, may be stored at room temperature for up to 8 hours, or at 2 C to 8 C for up to 16 hours.
Reconstitution/preparation techniques: The manufacturer product information should be consulted.
General:
- This drug is not effective or indicated for treating bleeding related to any FXa inhibitors other than apixaban or rivaroxaban.
Monitoring:
- Cardiovascular: Arterial and venous thromboembolic events, ischemic events, and cardiac arrest
Patient Advice:
- Arterial and venous thromboembolic events, ischemic events, cardiac events, and sudden death were observed within 30 days after administration of this drug.
- Reversing FXa inhibitor therapy may increase the risk of thromboembolic events.
More about coagulation factor Xa
- Check interactions
- Compare alternatives
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- During pregnancy
- Drug class: anticoagulant reversal agents
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- Coagulation factor Xa drug information
- Coagulation factor xa recombinant, inactivated-zhzo (Advanced Reading)
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