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All About Bleeding

Prothrombin Complex Concentrates (PCCs)

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Kcentra® Phase III Data Published in the Lancet

Study Finds Kcentra® is Superior to Plasma in Patients Needing Warfarin Reversal for Urgent Surgical or Invasive Procedures

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Kcentra® Receives FDA Approval for Use in Warfarin Reversal in Patients Undergoing Surgery

13 Dec 2013 - New Kcentra label includes urgent reversal of warfarin in an emergency surgery setting

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Kcentra® Study Demonstrates Positive Efficacy and Safety Profiles

Study shows Kcentra superior to plasma for warfarin reversal in patients requiring an urgent surgical procedure

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13 Dec 2013 - Kcentra Approved by FDA for Urgent Warfarin Reversal

Kcentra is the first FDA-Approved 4-Factor Prothrombin Complex Concentrate for warfarin reversal in the U.S.

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Prothrombin complex concentrates (PCCs)

Prothrombin complex concentrates (PCCs) are pooled, virus-inactivated human plasma products that conveniently and rapidly provide coagulation factors. The majority of PCCs contain the vitamin K-dependent coagulation factors (II [prothrombin], VII, IX and X), as well as therapeutically effective concentrations of thromboinhibitors (protein C and S).

PCCs are most commonly indicated and used in vitamin K antagonist reversal (oral anticoagulant reversal). In Europe they are also indicated for treatment and perioperative prophylaxis of bleeds in acquired deficiency of the prothrombin complex coagulation factors (II, VII, IX and X).4-5

Beriplex® P/N is indicated for:
  • Treatment and perioperative prophylaxis of bleedings in acquired deficiency of the prothrombin complex coagulation factors, such as deficiency caused by treatment with vitamin K antagonists, or in case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required.
  • Treatment and perioperative prophylaxis of bleedings in congenital deficiency of any of the vitamin K dependent coagulation factors when purified specific coagulation factor products are not available.
Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with:
  • acute major bleeding or
  • need for an urgent surgery/invasive procedure

Although larger randomized trial data are not yet available, several retrospective studies on the efficacy and safety of treatment with PCCs in perioperative bleeding and in patients with liver disease do exist.6-9

In one example PCCs were also used for treatment of bleeding in trauma patients in combination with fibrinogen concentrate.10 They offer a rapid means to stabilize coagulation without volume overload or pathogen transmission.11 They are the treatment of choice in several recently published warfarin reversal guidelines when maximum plasma levels of vitamin K-dependent coagulation factors are rapidly needed in a severe, emergency bleeding episode.5, 12

If you would like to learn more about perioperative bleeding and recent advances to treatment, please visit perioperativebleeding.org.

CSL Behring Products

Package Inserts

CSL Behring freeze-dried prothrombin complex concentrate (PCC) products include:

Product Websites

Beriplex.co.uk (United Kingdom)
Kcentra.com (United States)

Registration status and indications vary from country to country. Please contact your local CSL Behring representative and review the respective prescribing information.

Last Updated: 2/12/2015 5:04 PM
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