Factor IX Complex (Prothrombin Complex Concentrate)

Kcentra (aka Beriplex)

  • Source/Preparation: human plasma-derived
  • Content
    • Coagulant factors II, VII, IX, and X (all of which are vitamin K-dependent): approximaely 25x more concentrated than are present in plasma
    • Anticoagulant proteins C and protein S (both of which are vitamin K-dependent)
  • Pharmacology
    • A single Kcentra infusion produces a rapid and sustained increase in plasma concentration of factors II, VII, IX, and X within 30 min
  • Indications
    • Reversal of Coumadin-Associated Coagulopathy (see Coumadin, [[Coumadin]])
    • Hemorrhage in Patients with Critical Illnesses or Severe Liver Disease Involving Deficiency of Vitamin K-Dependent Coagulation Factors (see End-Stage Liver Disease, [[End-Stage Liver Disease]])
  • Contraindications
    • Hx of Heparin-Induced Thrombocytopenia (HIT): Kcentra contains heparin
    • Disseminated intravascular coagulation (DIC)
  • Adverse Effects: headache, nausea/vomiting, arthralgia, hypotension, thromboembolic events (stroke, pulmonary embolism, and deep venous thrombosis)
    • As Kcentra is derived from human plasma, the risk of transmission of infectious agents (including viruses and Creutzfeldt-Jakob disease agent) cannot be completely eliminated
  • Dosing: IV
    • Mean infusion time with Kcentra is 7x faster than with fresh frozen plasma (mean duration 24 min vs almost 3 hrs)
    • Requires 87% less volume than fresh frozen plasma
    • Does not require thawing or blood-type matching

Profilnine SD

  • Source/Preparation: human plasma-derived
  • Content: lyophilized powder of factors IX, II, X, and low amount of VII (human)
  • Indications
    • Control and Prevention of Hemorrhage in Patients with Factor IX Deficiency (Hemophilia B, Christmas Disease) (see Hemophilia B, [[Hemophilia B]])
    • Reversal of Coumadin-Associated Coagulopathy (see Coumadin, [[Coumadin]])
    • Reversal of Dabigatran-Associated Coagulopathy (see Dabigatran, [[Dabigatran]])
    • Reversal of Rivaroxaban-Associated Coagulopathy (see Rivaroxaban, [[Rivaroxaban]])
  • Contraindications
    • xxx
  • Adverse Effects: xxx
  • Dosing: 30 IU/kg IV Push (not to exceed 10 ml/min)

Bebulin VH

  • Source/Preparation: heat-treated
  • Content: lyophilized powder for solution of purified freeze-dried concentrate of coagulation factors IX, II, X, and low amounts of VII (human)
  • Indications
    • Control and prevention of hemorrhagic episodes in patients with factor IX deficiency (hemophilia B, Christmas disease)
  • Contraindications
    • xxx
  • Adverse Effects: xxx
  • Dosing: 1.2 international units/kg x body wt (kg) x desired increase (% of normal) IV

Proplex T

  • Content
    • xxx
  • Indications
    • Treatment of Factor VII deficiency in patients undergoing surgery; Hemophilia A

References

  • Influence of prothrombin complex concentrates on plasma coagulation in critically ill patients. Intensive Care Med. 1999 Oct;25(10):1105-10 [MEDLINE]
  • Efficacy and safety of a prothrombin complex concentrate with two virus-inactivation steps in patients with severe liver damage. Eur J Gastroenterol Hepatol. 2003 Jan;15(1):15-20 [MEDLINE]
  • Prophylactic use of factor IX concentrate in a Jehovah’s Witness patient. Ann Thorac Surg. 2009 Nov;88(5):1666-8
  • Prothrombin complex concentrates: an update. Blood Transfus. 2010;8(3):149-154 [MEDLINE]
  • Beriplex┬« P/N Anticoagulation Reversal Study Group. Prothrombin complex concentrate (Beriplex┬« P/N) for emergency anticoagulation reversal: a prospective multinational clinical trial. J Thromb Haemost. 2008;6(4):622-631