Prothrombin Complex Concentrate, human

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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 (VKA) such as Warfarin (Coumadin).[1][2][3]

Route: IV
Extravasation: no information

For conciseness and simplicity, 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]

Diseases for which it is used

Patient drug information

History of changes in FDA indication

  • 2013-04-29: Kcentra approved for the urgent reversal of vitamin K antagonist (VKA) anticoagulation in adults with acute major bleeding.
  • 2023-07-25: Balfaxar approved for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures. (Based on LEX-209)

Also known as

  • Generic names: 4-factor prothrombin complex concentrate, factor IX complex, PCC, prothrombin complex concentrate human-lans
  • Brand names: Balfaxar, Beriplex, Confidex, Kcentra, Octaplex, Profilnine