The Use of 3-and 4-Factor Prothrombin Complex Concentrate in Patients With Elevated INR

Background: PCC (Kcentra (R)) is an Food and Drug Administration (FDA)-approved 4-factor PCC used for the treatment of warfarin-related coagulopathy (WRC), but it has also been used off-label to treat non-WRC. Three-factor PCC in the form of coagulation factor IX human (Bebulin (R)) has also been used for WRC and off-label to treat non-WRC. It is unclear whether the use of 3- or 4-factor PCCs is effective for the treatment of non-WRC,. Objective: Our aim is to characterize the use of 3- and 4-factor PCCs for patients identified with a non-WRC. Methods: A retrospective analysis of patients who received PCCs for both WRC and non-WRC between January 2012 and July 2015 was conducted. Results: A total of 187 patients with elevated international normalized ratio (INR) who received PCCs were analyzed; 53.9% of patients in the WRC group and 27.7% in the non-WRC group corrected to an INR of 1.3 or less after 3- or 4-factor PCC administration. In those patients with non-WRC and who had underlying liver disease, 3- and 4-factor PCCs reduced mean INR by 0.98 and 1.43, respectively. Conclusion: Three and 4-factor PCCs can reduce INR in patients with WRC and in those with non-WRC secondary to liver disease.