374
Views
9
CrossRef citations to date
0
Altmetric
Drug Profile

Four factor prothrombin complex concentrate (human): review of the pharmacology and clinical application for vitamin K antagonist reversal

&

References

  • Ansell J, Hirsh J, Hylek E, et al. Pharmacology and management of the vitamin K antagonists. American College of Chest Physicians evidence-based clinical practice guidelines (8th edition). Chest 2008;133:160s-98s
  • Pengo V, Pegoraro C, Cucchini U, IIiceto S. The management of oral anticoagulant therapy: the ISAM study. J Thromb Thrombolysis 2006;21:73-7
  • Schulman S, Beyth RJ, Kearon C, Levine MN. Hemorrhagic complications of anticoagulant and thrombolytic treatment: american college of chest physicians evidence-based clinical practice guidelines (8th edition). Chest 2008;13:257S-98S
  • Ageno W, Gallus AS, Wittkowsky A, et al. Oral anticoagulant therapy: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012;141:e44S-88S
  • Bechtel BF, Nunez TC, Lyon JA, et al. Treatments for reversing warfarin anticoagulation in patients with acute intracranial hemorrhage: a structured literature review. Int J Emerg Med 2011;4:40
  • Vang ML, Hvas AM, Ravn HB. Urgent reversal of vitamin K antagonist therapy. Acta Anaesthesiol Scand 2011;55:507-16
  • Yang L, Stanworth S, Hopewell S, et al. Is fresh-frozen plasma clinically effective? An update of a systematic review of randomized controlled trials. Transfusion 2012;52:1673-86
  • Hillyer CD, Shaz BH, Zimring JC, Abshire TC. Bleeding risks with vitamin K deficiency. In: Abshire TC, editors. Transfusion medicine and hemostasis. Clinical and laboratory aspects. 1st edition. Elsevier Publishers; Burlington, USA: 2009. p. 571-5
  • Murphy JE. Warfarin. In: Wittkowsky AK, editor. Clinical pharmacokinetics. 5th Edition. American Society of Health-System Pharmacists; Bethesda, USA: 2011. p. 351-72
  • Bennett ST, Lehman CM, Rodgers GM. Monitoring anticoagulant therapy. In: Bennett ST, editors. Laboratory hemostasis. A practical guide for pathologists. 1st edition. Springer Science + Business Media, LLC Publishers, New York, USA; 2007. p. 167-205
  • Link KP. The discovery of dicumarol and its sequels. Circulation 1959;19:97-107
  • Whitelon DS, Sadowwski JA, Suttie JW. Mechanisms of coumarin action: significance of vitamin K epoxide reductase inhibition. Biochemistry 1978;17:137-1377
  • Fasco MJ, Hildebrandt EF, Suttie JW. Evidence that warfarin anticoagulant action involved two distinct reductase activities. J Biol Chem 1982;257:11210-12
  • Choonara IA, Malia RG, Haynes BP, et al. The relationship between inhibition of vitamin K1 2,3-epoxide reductase and reduction of clotting factor activity with warfarin. Br J Clin Pharmacol 1988;25:1-7
  • Triveldi LS, Rhee M, Galivan JH, et al. Normal and warfarin-resistant rat hepatocyte metabolism of vitamin K 2,3 epoxide: evidence for multiple pathways of hydroxyvitamin K formation. Arch Biochem Biophys 1988;264:67-73
  • Stenflo J, Fernlund P, Eegan W, et al. Vitamin K dependent modifications of glutamic acid residues in prothrombin. Proc Natl Acad Sci USA 1974;71:2730-3
  • Stafford DW. The vitamin K cycle. J Thromb Haemost 2005;3:1873-8
  • Kumar S, Haight JRM, Tate G, et al. Effect of warfarin on plasma concentrations of vitamin K dependent coagulation factors in patients with stable control and monitored compliance. Br J Haematol 1990;72:82-5
  • Wittkowsky AK. Why warfarin and heparin need to overlap when treating acute venous thromboembolism. Dis Mon 2005;51:112-15
  • O’Reilly RA. Studies of the optical enantiomorphs of warfarin in man. Clin Pharmacol Ther 1974;16:348-54
  • Breckenridge A, Orme M, Wessling H, et al. Pharmacokinetics and pharmacodynamics of the enantiomers of warfarin in man. Clin Pharmacol Ther 1973;15:424-30
  • Hignite C, Uetriecht J, Tschanz C, et al. Kinetics of R and S warfarin enantiomers. Clin Pharmacol Ther 1980;28:99-105
  • Hewick DS, McEwen J. Plasma half-lives, plasma metabolites, and anticoagulant efficacies of the enantiomers of warfarin in man. J Pharm Pharmacol 1983;25:458-65
  • Paul B, Oxley A, Brigham K, et al. Factor II, VII, IX and X concentrations in patients receiving long term warfarin. J Clin Pathol 1987;40(1):94-8
  • Kitchen S, Preston FE. Standardization of prothrombin time for laboratory control of oral anticoagulation therapy. Semin Thromb Hemost 1999;25:17-25
  • Holbrook A, Schulman S, Witt DM, et al. Evidence-based management of anticoagulant therapy: antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence based clinical practice guidelines. Chest 2012;141:e152s-84s
  • Keeling D, Baglin T, Tait C, et al. Guidelines on oral anticoagulation with warfarin- fourth edition. Br J Haematol 2011;154:311-24
  • Hylek EM, Change YC, Skates SJ, et al. Prospective study of the outcomes of ambulatory patients with excessive warfarin anticoagulation. Arch Intern Med 2000;160:1612-17
  • Hylek EM, Singer DE. Risk factors for intracranial hemorrhage in outpatients taking warfarin. Ann Intern Med 1994;120:897-902
  • Fihn SD, McDonell M, Martin D, et al. Risk factors for complications of chronic anticoagulation. A multicenter study. Warfarin optimized outpatient follow-up study group. Ann Intern Med 1993;188:511-20
  • Hanke AA, Joch C, Gorlinger K. Long-term safety and efficacy of a pasteurized nanofiltrated prothrombin complex concentrate (Beriplex P/N): a pharmacovigilance study. Br J Anaesth 2013;110:764-72
  • Spahn DR, Bouillon B, Cerny V, et al. Management of bleeding following major trauma: an updated European guideline. Crit Care 2013;17:R76
  • Cartmill M, Dolan G, Byrne JL, Pyrne PO. Prothrombin complex concentrate for oral anticoagulant reversal in neurosurgical emergencies. Br J Neurosurg 2000;14:458-61
  • Evans G, Luddington R, Baglin T. Beriplex P/N reverses severe warfarin –induced overanticoagulation immediately and completely in patients presenting with major bleeding. Br J Haematol 2001;115:998-1001
  • Huttner HB, Schellinger PD, Hartmann M, et al. Hematoma growth and outcome in treated neurocritical care patients with intracerebral hemorrhage related to oral anticoagulant therapy: comparison of acute treatment strategies using vitamin K, fresh frozen plasma, and prothrombin complex concentrates. Stroke 2006;37:1465-70
  • Lubetsky A, Hoffman R, Zimlichman R, et al. Efficacy and safety of prothrombin complex concentrate (Octaplex) for rapid reversal of oral anticoagulant. Thromb Res 2004;113:371-8
  • Makris M, Greaves M, Phillips WS, et al. Emergency oral anticoagulant reversal: the relative efficacy of infusions of fresh frozen plasma and clotting factor concentrate on correction of the coagulopathy. Thromb Haemost 1997;77:477-80
  • Pabinger I, Brenner B, Kalina U, et al. Prothrombin complex concentrate (Beriplex P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J thromb Haemost 2008;6:622-31
  • Pabinger I, Tiede A, Kalin U, et al. Impact of infusion speed on the safety and effectiveness of prothrombin complex concentrate: a prospective clinical trial of emergency anticoagulation reversal. Ann Hematol 2010;89:309-16
  • Preston FE, Laidlaw ST, Sampson B, Kitchen S. Rapid reversal of oral anticoagulation with warfarin by a prothrombin complex concentrate (Beriplex): efficacy and safety in 42 patients. Br J Haematol 2002;116:619-24
  • Riess HB, Meier-Hellmann A, Motsch J, et al. Prothrombin complex concentrate (Octaplex) in patients requiring immediate reversal of oral anticoagulation. Thromb Res 2007;121:9-16
  • Vigue B, Ract C, Tremey B, et al. Ultra-rapid management of oral anticoagulant therapy-related surgical intracranial hemorrhage. Intensive Care Med 2007;33:721-5
  • Yasaka M, Sakata T, Minematsu K, Maritomi H. Correction of INR by prothrombin comoplex concentrate and vitamin K in patients with warfarin related hemorrhagic complication. Thromb Res 2003;108:25-30
  • Dentali F, Marchesi C, Pierfranceschi MG, et al. Safety of prothrombin complex concentrates for rapid anticoagulation reversal of vitamin K antagonists. A meta-analysis. Thromb Haemost 2011;106:429-38
  • Holland L, Warkentin TE, Refaai M, et al. Suboptimal effect of a three factor prothrombin complex concentrate (Profilnine-SD) in correcting supratherapeutic international normalized ratio due to warfarin overdose. Transfusion 2009;49:1171-7
  • Ageno W, Garcia D, Aguilar MI, et al. Prevention and treatment of bleeding complications in patients receiving vitamin K antagonists, part 2: treatment. Am J Hematol 2009;84:584-8
  • Kalina U, Bickhard H, Schulte S. Biochemical comparison of seven commercially available prothrombin complex concentrates. Int J Clin Pract 2008;62:1614-22
  • Sarode R, Milling TJ, Refaai MA, et al. Efficacy and safety of four-factor prothrombin complex concentrate (4F-PCC) in patients on vitamin K antagonists presenting with major bleeding: a randomized, plasma controlled, phase IIIb study. Circulation 2013;128:1234-43
  • Ostermann H, Haertel S, Knaub S, et al. Pharmacokinetics of Beriplex P/N prothrombin complex concentrate in healthy volunteers. Thromb Haemost 2007;98:790-7
  • Refaai MA, Goldstein JN, Milling TJ Jr, et al. Randomized phase IIIb study of rapid vitamin K antagonist reversal In patients requiring an urgent surgical procedure: four-factor prothrombin complex concentrate is superior to plasma. Proceedings of the 55th American Society of Hematology. New Orleans, LA, USA, 3588 (2013). 2013 Annual meeting abstracts. Blood 2013;122:423
  • CSL Behring. Kcentra™ Prescribing Information. 2013. Available from: http://www.kcentra.com/prescribing-information.aspx [Last accessed 23 December 2013]
  • Staudinger T, Frass M, Rintelen C, et al. Influence of prothrombin complex concentrates on plasma coagulation in critically ill patients. Intensive Care Med 1999;25:1105-10
  • Sorensen B, Spahn DR, Innerhofer P, et al. Clinical review: prothrombin complex concentrates- evaluation of safety and thrombogenicity. Crit Care 2011;15:201
  • Kohler M. Thrombogenicity of prothrombin complex concentrates. Thromb Res 1999;95:S13-17
  • Kohler M, Hellstern P, Lechler E, et al. Thromboembolic complications associated with the use of prothrombin complex and factor IX concentrates. Thromb Haemost 1998;80:399-402
  • Key NS, Negreir C. Coagulation factor concentrates: past, present, and future. Lancet 2007;370:439-48
  • Kcentra™ US FDA Biologic license application. Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM350239.pdf [Last accessed 23 December 2013]
  • Petrides M, Stack G, Cooling L, Maes LY. Indications for transfusion. In: Petrides M, editor. Practical guide to transfusion medicine. AABB Press; Bethesda, USA: 2007. p. 203-26
  • Patanwala AE, Acquisto NM, Erstad BL. Prothrombin complex concentrate for critical bleeding. Ann Pharmacother 2011;45:990-1000
  • Lisman T, Bakhtiari K, Adelmeijer J, et al. Intact thrombin generation and decreased fibrinolytic capacity in patients with acute liver injury or acute liver failure. J Thromb Haemost 2012;10:1312-19
  • Lisman T, Leebeek FW, de Groot PG. Haemostatic abnormalities in patients with liver disease. J Hepatol 2002;37:280-7
  • Lisman T, Porte RJ. Rebalanced hemostasis in patients with liver disease: evidence and clinical consequences. Blood 2010;116:878-85
  • Tripodi A, Salerno F, Chantarangkul V, et al. Evidence of normal thrombin generation in cirrhosis despite abnormal conventional coagulation tests. Hepatology 2005;41:553–8
  • Hess JR, Hauser CJ, Mackway Jones J, Rizoli SB. The coagulopathy of trauma: a review of mechanisms. J Trauma 2005;65:748-54
  • Griffee MJ, Deloughery TG, Thorborg PA. Coagulation management in massive bleeding. Curr Opin Anaesthesiol 2010;23:263-8
  • Brohi K, Cohen MJ, Ganter MT, et al. Acute coagulopathy of trauma: hypoperfusion induces systemic anticoagulation and hyperfibrinolysis. J Trauma 2008;64:1211-17
  • Johansson PI, Stissing T, Bochsen L, Ostrowski SR. Thromboelastography and thromboelastometry in assessing coagulopathy of trauma. Scand J Trauma Resusc Emerg Med 2009;17:45
  • Connolly SJ, Ezebowitz MD, Yusuf S, et al. Dabigatran versus warfarin in patients with atrial fibrillation. NEJM 2009;361:1139-51
  • Patel MR, Mahaffey KW, Garg J, et al. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. NEJM 2011;365:883-91
  • Granger CB, Alexander JH, McMurrar JJ, et al. Apixaban versus warfarin in patients with atrial fibrillation. NEJM 2011;365:981-92
  • Agnelli G, Buller HR, Cohen A, et al. Oral apixaban for the treatment of acute venous thromboembolism. NEJM 2013;369:800-8

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.