Year 2021
September 2021


Abstract Title
Drug Use Evaluation of 4-Factor Prothrombin Complex Concentrate (4-FPCC Octaplex®) in Khoo Teck Puat Hospital



Khoo Teck Puat Hospital1

Background & Hypothesis

4-FPCC is indicated for reversal of Warfarin in life-threatening bleeds or for urgent procedures. It is also commonly used for off-label reversal of Direct Oral Anticoagulants (DOACs). This drug use evaluation aims to review the appropriateness of 4-FPCC use in Khoo Teck Puat Hospital (KTPH) based on a in-house protocol, and to evaluate its efficacy and safety.


A retrospective review of KTPH medical records in 2019 was performed. Patients with at least 1 dose of 4-FPCC administered in the emergency department and in all wards were included. Fifty incidences of 4-FPCC use from 47 patients were collected.


88% of 4-FPCC were used for appropriate indications while the remaining 12% had no underlying anticoagulant to be reversed. 70% of 4-FPCC were dosed appropriately. Inappropriate dosing mostly occurred when INR was less than 2 for Warfarin or when scheduled doses of DOACs had not been taken. Overall haemostatic efficacy was 61%, and was significantly lower when used inappropriately (40% vs 71%, P=0.04). Efficacy was comparable between Warfarin and DOAC reversals. Overall rate of thromboembolic events was 4%. Overall mortality was 24%. Mortality (40% vs 17%, P=0.07) and length of stay (37.9 days vs 16.1 days, P=0.05) were greater when used inappropriately.

Discussion & Conclusion

4-FPCC was appropriately indicated in all Warfarin and DOAC reversals in KTPH during the study period. Efficacy and safety were compromised when 4-FPCC was used without an underlying anticoagulant or at off-label doses. More guidance on 4-FPCC dosing is required in cases where patients are suspected to be under-anticoagulated (e.g. INR<2).