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prothrombin complex concentrate (Autoplex-T, Kcentra)

Contains vitamin K-dependent clotting factors: - factor IX - factor VII - factor X - protein C - protein S - prothrombin Prepared from pooled human plasma. Variable in content. * 4 factor prothrombin complex concentrate can restore clotting activity in ~100% of patients * 3 factor prothrombin complex concentrate lacks factor VII & requires supplemental fresh frozen plasma or recombinant factor VIIa [4] Indications: - prothrombin deficiency - reversal of vitamin K antagonist (warfarin) anticoagulation in adults with major bleeding [3,4,5] (treatment of choice) [4] - reversal of rivaroxaban anticoagulation [2] Contraindications: - does not reverse dabigatran anticoagulation [2] - coagulopathy of liver disease [4] Dosage: - start with 25-50 U/kg of factor IX content or factor VIII correctional unit equivalent, IV infusion - QD or QOD dosing * small volume; stored at room temp; no need for ABO typing

General

hematologic agent

References

  1. Hagstrom SJ and Harper JL eMedicine: Hypoprothrombinemia http://emedicine.medscape.com/article/956030-overview
  2. Eerenberg ES et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: A randomized, placebo-controlled, crossover study in healthy subjects. Circulation 2011 Oct 4; 124:1573. PMID: 21900088 - Battinelli EM. Reversal of new oral anticoagulants. Circulation 2011 Oct 4; 124:1508. PMID: 21969317
  3. FDA News Release: April 29, 2013 FDA approves Kcentra for the urgent reversal of anticoagulation in adults with major bleeding. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm350026.htm - Prescriber's Letter 20(10): 2013 ALGORITHM: How to Manage High INRs in Warfarin Patients CHART: Clotting Factors for Reversing Anticoagulants Detail-Document#: 291012 (subscription needed) http://www.prescribersletter.com
  4. Medical Knowledge Self Assessment Program (MKSAP) 17, 18, 19. American College of Physicians, Philadelphia 2015, 2018, 2022.
  5. Sarode R, Milling TJ Jr, Refaai MA et al Efficacy and safety of a 4-factor prothrombin complex concentrate in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma-controlled, phase IIIb study. Circulation. 2013 Sep 10;128(11):1234-43 PMID: 23935011
  6. Goldstein JN, Refaai MA, Milling TJ Jr, et al Four-factor prothrombin complex concentrate versus plasma for rapid vitamin K antagonist reversal in patients needing urgent surgical or invasive interventions: a phase 3b, open-label, non-inferiority, randomised trial. Lancet. 2015 May 23;385(9982):2077-87. Epub 2015 Feb 27. PMID: 25728933

Component-of

factor ix/factor vii/factor x/protein c/protein s/prothrombin/prothrombin complex concentrate

Components

coagulation factor IX; Christmas factor; plasma thromboplastin component; PTC; contains: coagulation factor IXa light chain; coagulation factor IXa heavy chain (F9) coagulation factor VII; proconvertin; serum prothrombin conversion accelerator; SPCA; Eptacog alfa; contains: factor VII light chain; factor VII heavy chain (F7) coagulation factor X; Stuart factor; Stuart-Prower factor; contains: factor X light chain; factor X heavy chain; activated factor Xa heavy chain (F10) protein C; vitamin K-dependent protein C; anticoagulant protein C; autoprothrombin IIA; blood coagulation factor XIV; contains: vitamin K-dependent protein C light chain; vitamin K-dependent protein C heavy chain; activation peptide (PROC) protein S; vitamin K-dependent protein S (PROS1, PROS) prothrombin; coagulation factor II; contains: activation peptide fragment 1; activation peptide fragment 2; thrombin light chain; thrombin heavy chain (F2)