Frequently Asked Questions

What is Kcentra and what is it indicated for?

Kcentra is a purified, heat-treated, nanofiltered, lyophilized, non-activated 4-factor prothrombin complex concentrate (4F-PCC) made from pooled human plasma. Kcentra contains all 4 Vitamin-K dependent coagulation factors (II, VII, IX and X), and the antithrombotic Proteins C and S.

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.

How is Kcentra made?

Kcentra is manufactured using the CSL Behring Integrated Safety System, a rigorously controlled manufacturing process that is continuously monitored. All plasma used in the manufacturing of Kcentra is obtained from pre-screened US donors, and is carefully tested. A multi-step pathogen inactivation and removal process, including heat treatment and virus filtration, is used to reduce the risk of transmission of infectious agents. The risk of virus transmission cannot be completely eliminated.

How does Kcentra work?

During VKA treatment, there is a dose-dependent acquired deficiency of the Vitamin K-dependent coagulation factors. The administration of Kcentra increases plasma levels of the Vitamin K-dependent coagulation Factors II, VII, IX, and X, as well as the antithrombotic Proteins C and S.

How is Kcentra dosed?

Kcentra is dosed based on units of Factor IX. The dose is determined by the patient’s pre-dose INR and body weight.

Kcentra dose is determined by patient’s pre-dose INR and body weight

What distinguishes Kcentra from plasma / coagulation products?

Coagulation factors in Kcentra are 25 times more concentrated than in plasma, enabling factor levels to be replenished rapidly without delivering a large intravascular volume load.1 Compared with plasma, Kcentra requires less infusion volume, allowing faster administration with comparable safety.

VKAs like warfarin act by inhibiting the synthesis of fully functional Vitamin K-dependent coagulation Factors II, VII, IX, and X. Warfarin also results in a functional deficit of the antithrombotic Proteins C and S, which results in a disruption of normal hemostasis.11 Currently available 3-factor PCCs contain low or variable levels of factor VII and do not include antithrombotic proteins C and S.6, 7 Kcentra contains all 4 Vitamin-K dependent coagulation factors (II, VII, IX and X), and the antithrombotic Proteins C and S.

Unlike 3F-PCCs that are only indicated for hemophilia, Kcentra (as a 4F-PCC) has an FDA indication for urgent warfarin reversal.6, 7

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

Can Kcentra be prepared and infused faster than plasma?

Unlike fresh frozen plasma (FFP), Kcentra does not require thawing or ABO typing. Kcentra can be stored at room temperature for up to 36 months.

In clinical trials, infusion with Kcentra is approximately 7 times faster than with plasma. In the Acute Major Bleeding Trial, mean infusion time was 24 minutes for Kcentra and 169 minutes for plasma. In the Urgent Surgery / Invasive Procedure Trial, mean infusion time was 21 minutes for Kcentra and 141 minutes for plasma.

How effective was Kcentra in clinical trials?

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

In a 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 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.

How is Kcentra administered?

Administer Kcentra by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min) up to a maximum rate of 8.4 mL/min (~210 units/min).

Administer Vitamin K concurrently to patients receiving Kcentra. Vitamin K is administered to maintain Vitamin K-dependent clotting factor levels once the effects of Kcentra have diminished.

Why must Vitamin K be used with Kcentra?

The administration of Vitamin K is expected to maintain factor levels once the effects of Kcentra have diminished.

The dose of Vitamin K is not specified in the prescribing information. Hospitals may have their own protocols; if not, they can contact 855-4KCENTRA or medinfona@cslbehring.com for information on Vitamin K doses used in the clinical trials for Kcentra.

How is Kcentra stored?

Prior to Reconstitution

  • Kcentra is for single use only and contains no preservatives.
  • Store Kcentra between 2 - 25°C (36 - 77°F), not to exceed 25°C (77°F). This allows room temperature storage. Do not freeze.
  • Kcentra is stable for 36 months from the date of manufacture, up to the expiration date on the carton and vial labels. Do not use beyond the expiration date on the vial label and carton.
  • Store the vial in the original carton to protect it from light.

After Reconstitution

  • The product must be used within 4 hours following reconstitution. Reconstituted product can be stored at 2 - 25°C. If cooled, the solution should be warmed to 20 - 25°C prior to administration.
  • Do not freeze the reconstituted product. Discard partially used vials.
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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