Prothrombin Complex Concentrate, human
FDA approved 4/29/2013
General information
Class/mechanism: Concentrate of vitamin K-dependent coagulation factors II (FII), VII (FVII), IX (FIX), X (FX), and protein C and protein S. Use of prothrombin complex concentrate can help control acute major bleeding that may result from acquired deficiency of vitamin K-dependent coagulation factors (supratherapeutic INR) in patients who are using vitamin K antagonists such as Warfarin (Coumadin).[1][2][3]
Route: IV
Extravasation: no information
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Patient drug information
- Brief patient counseling information can be found on page 7 of the Prothrombin Complex Concentrate, Human (Kcentra) package insert[1]
History of changes in FDA indication
- 4/29/2013: FDA approved "for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding."