Table 5.

Comparison of 4F-PCC and andexanet alfa for the reversal of direct factor Xa inhibitors

Reversal agent4F-PCCAndexanet alfa
Mechanism of action Reverses PT and endogenous thrombin generation; indirect, nonspecific pro-hemostatic Acts as a “decoy” via binding and sequestering the factor Xa inhibitors
Direct specific antidote 
Dose 50 U/kg for major bleeding or a fixed dose of 2000 U used for simplicity Dose depends on the dose and timing of the last dose of the FXa inhibitor*
Low dose: 400 mg intravenous bolus at 30 mg/min, followed by infusion of 480 mg at 4 mg/min for up to 2 h
High dose: 800 mg intravenous bolus at 30 mg/min, followed by infusion of 960 mg 8 mg/min for up to 2 h 
Availability Readily available at most hospitals Limited availability 
Rate of effective management of major bleeding (95% CI) With the ISTH criteria: 69% (61%-76%)
Not using the ISTH criteria: 75% (53%-97%)70  
83% (75%-89%)69  
Rate of thromboembolic complications (95% CI) 5% (1%-9%)70  11% (NA)69  
Cost $1.27 per unit71  For 2000 U 4F-PCC $2540 $3300 per vial of 100 mg72  Low dose (9 vials) $29 700, high dose (18 vials) $59 400 
Reversal agent4F-PCCAndexanet alfa
Mechanism of action Reverses PT and endogenous thrombin generation; indirect, nonspecific pro-hemostatic Acts as a “decoy” via binding and sequestering the factor Xa inhibitors
Direct specific antidote 
Dose 50 U/kg for major bleeding or a fixed dose of 2000 U used for simplicity Dose depends on the dose and timing of the last dose of the FXa inhibitor*
Low dose: 400 mg intravenous bolus at 30 mg/min, followed by infusion of 480 mg at 4 mg/min for up to 2 h
High dose: 800 mg intravenous bolus at 30 mg/min, followed by infusion of 960 mg 8 mg/min for up to 2 h 
Availability Readily available at most hospitals Limited availability 
Rate of effective management of major bleeding (95% CI) With the ISTH criteria: 69% (61%-76%)
Not using the ISTH criteria: 75% (53%-97%)70  
83% (75%-89%)69  
Rate of thromboembolic complications (95% CI) 5% (1%-9%)70  11% (NA)69  
Cost $1.27 per unit71  For 2000 U 4F-PCC $2540 $3300 per vial of 100 mg72  Low dose (9 vials) $29 700, high dose (18 vials) $59 400 

CI, confidence interval; NA, not available.

*

Low dose is used for all patients receiving apixaban and for those receiving rivaroxaban ≥8 h ago. High dose is used for those receiving rivaroxaban <8 h ago or at an unknown time.

Price is in USD. Cost of 4F-PCC is lower in Canada and Europe.

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