What is Kcentra? Kcentra is the First and Only Non-Activated 4-Factor Prothrombin Complex Concentrate (4F-PCC) for Urgent Warfarin Reversal

Kcentra is indicated for the urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, such as warfarin) therapy in adult patients with:

  • acute major bleeding
  • need for urgent surgery or other invasive procedure

Kcentra is for intravenous use only.

Proven Effective Across a Broad Range of Patients Requiring Urgent Warfarin Reversal

  • Kcentra has been studied in approximately 200 patients with acute major bleeding and in approximately 170 patients needing urgent surgery or another invasive procedure.
  • Kcentra was non-inferior to plasma in achieving effective hemostasis in patients with acute major bleeding.
  • Kcentra was superior to plasma in achieving effective hemostasis in patients requiring urgent surgery or other invasive procedure.

Effective Hemostasis When It Matters Most

Acute Major Bleeding Trial
Urgent Surgery / Invasive Procedures Trial
72.4% of subjects in acute major bleeding trials achieved effective hemostasis, assessed over 24 hours
89.7% of subjects in urgent surgery / invasive procedure trials achieved effective hemostasis at the end of their procedure

In the trial of patients with acute major bleeding, Kcentra met the efficacy endpoint of non-inferiority vs plasma in achieving effective hemostasis.

In the trial of patients requiring an urgent surgery or other invasive procedure, significantly more patients (89.7%) achieved effective hemostasis at the end of the procedure with Kcentra than with plasma (75.3%).

Superior INR Reduction vs Plasma

Acute Major Bleeding Trial
Urgent Surgery / Invasive Procedures Trial
62.2% of subjects experienced a reduction of INR (≤1.3 at 30 minutes after end of infusion) in acute major bleeding trials
55.2% of subjects experienced a reduction of INR (≤1.3 at 30 minutes after end of infusion) in urgent surgery / invasive procedure trials

In both clinical trials, Kcentra demonstrated superiority to plasma in achieving early INR reduction (≤1.3 at 30 minutes after end of infusion).

The relationship between INR values and clinical hemostasis in patients has not been established.

Kcentra – Ready When You Need It

Easy Access to Kcentra Enables Fast Initation of Therapy.

  • No need for thawing or ABO typing
  • 36-month room temperature storage
  • Available in 2 vial sizes for added convenience
Kcentra’s infusion time is ∼7 times faster compared to plasma in both acute major bleeding and urgent surgery / invasive procedure trials

Rapid Administration with Low Infusion Volume

  • Infusion time with Kcentra is about 7 times faster than with plasma.
  • Mean infusion time was 24 minutes for Kcentra and 169 minutes for plasma in the Acute Major Bleeding Trial. Mean infusion time was 21 minutes for Kcentra and 141 minutes for plasma in the Urgent Surgery / Invasive Procedure Trial.


Kcentra requires ∼85% less volume compared to plasma in both acute major bleeding and urgent surgery / invasive procedure trials

Kcentra requires about 85% less volume than plasma.

  • Mean infusion volume was 105 mL for Kcentra and 865 mL for plasma in the Acute Major Bleeding Trial. Mean infusion volume was 90 mL for Kcentra and 819 mL for plasma in the Urgent Surgery / Invasive Procedure Trial.
  • Coagulation factors in Kcentra are about 25 times more concentrated than in plasma, meaning that significantly less volume is required to infuse the same concentration of factors.1

Kcentra has a Safety Profile Comparable With Plasma

Adverse reactions reported in more than 5 subjects (≥2.8%) following Kcentra or plasma administration in both randomized, controlled trials
Adverse reactions reported in more than 5 subjects (≥2.8%) following Kcentra or plasma administration in both randomized, controlled trials

State-of-the-art plasma collection and manufacturing processes help ensure a safe supply for meeting patients' needs.

Kcentra Offers Reliable Support

The Kcentra hotline (18554KCENTRA) is available 24 hours a day, 7 days a week for additional product information, medical inquiries, reimbursement support, and resources

The Kcentra Hotline is available 24 hours a day, 7 days a week. Speak with a Kcentra Hotline representative for:

  • Additional product information
  • Medical inquiries
  • Reimbursement support
  • Resources

Kcentra has over 15 years of clinical experience as Beriplex® outside the US.2

Home About Kcentra
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Important Safety Information

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—eg, warfarin) therapy in adult patients with acute major bleeding or the need for urgent surgery or other invasive procedure. Kcentra is for intravenous use only.

WARNING: ARTERIAL AND VENOUS THROMBOEMBOLIC COMPLICATIONS

Patients being treated with Vitamin K antagonist therapy have underlying disease states that predispose them to thromboembolic events. Potential benefits of reversing VKA should be weighed against the risk of thromboembolic events, especially in patients with history of such events. Resumption of anticoagulation therapy should be carefully considered once the risk of thromboembolic events outweighs the risk of acute bleeding. Both fatal and nonfatal arterial and venous thromboembolic complications have been reported in clinical trials and postmarketing surveillance. Monitor patients receiving Kcentra, and inform them of signs and symptoms of thromboembolic events. Kcentra was not studied in subjects who had a thromboembolic event, myocardial infarction, disseminated intravascular coagulation, cerebral vascular accident, transient ischemic attack, unstable angina pectoris, or severe peripheral vascular disease within the prior 3 months. Kcentra might not be suitable for patients with thromboembolic events in the prior 3 months.

Kcentra is contraindicated in patients with known anaphylactic or severe systemic reactions to Kcentra or any of its components (including heparin, Factors II, VII, IX, X, Proteins C and S, Antithrombin III and human albumin). Kcentra is also contraindicated in patients with disseminated intravascular coagulation. Because Kcentra contains heparin, it is contraindicated in patients with heparin-induced thrombocytopenia (HIT).

Hypersensitivity reactions to Kcentra may occur. If patient experiences severe allergic or anaphylactic type reactions, discontinue administration and institute appropriate treatment.

In clinical trials, the most frequent (≥2.8%) adverse reactions observed in subjects receiving Kcentra were headache, nausea/vomiting, hypotension, and anemia. The most serious adverse reactions were thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

Kcentra is derived from human plasma. The risk of transmission of infectious agents, including viruses and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent, cannot be completely eliminated.

The safety and efficacy of Kcentra in pediatric use have not been studied, and Kcentra should be used in women who are pregnant or nursing only if clearly needed.

Please see full prescribing information for Kcentra.

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CSL Behring
Kcentra is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
Kcentra® and Beriplex® are registered trademarks of CSL Behring GmbH.
Biotherapies for Life® is a registered trademark of CSL Behring LLC
All other products mentioned are trademarks or registered trademarks of their respective companies.
© 2017 CSL Behring. The product information presented on this site is intended for US residents only.
KCT15-11-0051 12/2015