Why Use Kcentra? Kcentra Provides an Effective Response with Efficiency, Safety, and Reliability

Kcentra is the first non-activated, FDA-approved 4-Factor Prothrombin Complex Concentrate (4F-PCC) for urgent warfarin reversal in adult patients with:

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

Count On An Effective Response

In the trial of patients with acute major bleeding, Kcentra met the efficacy endpoint of non-inferiority versus 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%).

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

Proteins Warfarin
Depletes5
Kcentra 4F-PCC
replaces
3F-PCC6, 7, *
replaces
FFP8, 9
replaces
Fibrinogen       X
Factor II X X X X
Factor V       X
Factor VII X X Low levels X
Factor VIII       X
Factor IX X X X X
Factor X X X X X
Factor XI       X
Factor XII       X
Factor XIII       X
Protein C X X   X
Protein S X X   X

Count On Appropriate Factor Replacement

Unlike fresh frozen plasma (FFP), Kcentra replaces only those clotting factors needed for urgent warfarin reversal.

FFP = fresh frozen plasma.

*Profilnine SD is indicated for the prevention and control of bleeding in patients with Factor IX
 deficiency due to hemophilia B.

Count On Faster Restoration of Factor Levels

In the acute bleeding study, Kcentra restored depleted factor concentrations significantly faster than plasma. Results were similar in the surgical study.

Kcentra restores depleted factor concentrations significantly faster than plasma for all factors from 0.5 to 3 hours
Kcentra and Plasma Legend

Graphics reflect results in the Acute Major Bleeding Trial. Mean factor levels over time in the Urgent Surgery / Invasive Procedure Trial showed similar profiles.

Differences between treatment groups were statistically significant for all factors from 0.5 to 3 hours.

Kcentra’s infusion time is ∼7 times faster compared to plasma in both acute major bleeding and urgent surgery / invasive procedure trials

Infusion time with Kcentra is about 7x 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.

Count On Rapid Administration With Low Volume

Easy Access to Kcentra Enables Fast Initiation of Therapy

  • No need for thawing or ABO typing
  • 36-month room temperature storage
  • Available in 2 vial sizes for added convenience

Kcentra requires about 85% less infusion volume than plasma.

Count On Ample, Safe Supply

Kcentra has a safety profile comparable to plasma.

Factor IX is the lead factor for the potency of the preparation as stated on the vial label. However, Kcentra also includes small quantities of antithrombin III (ATIII) and heparin, as well as human albumin, sodium chloride, and sodium citrate.

Kcentra has a multi-step approach to quality and safety.

CSL Behring’s integrated safety system helps ensure that Kcentra meets high quality and safety standards for virus inactivation and reduction.

The risk of infectious agent transmission is reduced by:

From donor selection to pharmacovigilance, CSL Behring’s integrated safety system helps ensure that Kcentra meets high quality and safety standards
  • Screening and selection of US plasma donors
  • Virus testing
  • A multi-step approach to virus inactivation/removal, including dual nanofiltration of both enveloped and nonenveloped viruses

No causal relationship to Kcentra administration has been established for any report of suspected virus transmission since introduction of a virus filtration step in 1996. The risk of virus transmission cannot be totally eliminated.

Count On Reliable Support

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

Kcentra has over 15 years of clinical experience worldwide as Beriplex® outside the US, with approximately 650,000 doses administered.2

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
Home Why Use 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