Emergent Warfarin Reversal With Fixed-Dose 4-Factor Prothrombin Complex Concentrate

Area of Science:

• Pharmacology
• Critical Care Medicine
• Hematology

Background:

• Dosing of four-factor prothrombin complex concentrate (4FPCC) for emergent warfarin reversal is not standardized.
• Previous studies suggest lower, fixed-dose regimens may be effective and cost-saving.
• Further research is needed to establish optimal fixed-dose 4FPCC protocols.

Purpose of the Study:

• To evaluate the efficacy, safety, and cost-effectiveness of a fixed-dose 4FPCC regimen.
• To assess the achievement of target International Normalized Ratio (INR) levels post-administration.
• To analyze the incidence of thrombotic events and survival rates.

Main Methods:

• Retrospective chart review of 64 adult patients requiring emergent warfarin reversal with 4FPCC.
• Utilized a fixed-dose regimen of 1500 units of 4FPCC.
• Primary outcomes included post-4FPCC INR ≤1.5 and ≤2.0; secondary outcomes were thrombotic events and survival.

Main Results:

• 68.8% of patients achieved a post-4FPCC INR ≤1.5, and 95.3% achieved ≤2.0.
• No thrombotic events were reported within 7 days of 4FPCC administration.
• The fixed-dose protocol resulted in cost savings exceeding $1000 per patient.

Conclusions:

• A fixed dose of 1500 units of 4FPCC is effective in achieving target INR for emergent warfarin reversal.
• This dosing strategy appears safe, with no reported thrombotic events.
• Findings support the use of fixed-dose 4FPCC regimens as an alternative to package insert dosing.