Dosing and Administration

Dosing Guidelines

Kcentra is dosed based on units of Factor IX.

When calculating the Kcentra dose, it is important to check each vial for Factor IX units, since each lot can vary in potency. The Factor IX content in each vial can range from 400–620 units for the 500 U kit and 800-1240 units for the 1000 U kit. When reconstituted, the final concentration of drug product in Factor IX units will be in a range from 20-31 units/mL. The actual content of Factor IX as measured in units of potency is stated on the vial.

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

The safety and effectiveness of repeat dosing have not been established and it is not recommended.

Dose ranging within pre-treatment INR groups has not been studied in randomized clinical trials of Kcentra.

Kcentra Dosing Calculator

Use the Dosing Calculator to help determine the recommended Kcentra dose for your patients by using your patient's predose INR and body weight.

Administration Overview

Reconstitution Before Administration

Reconstitute using aseptic technique with 20 mL (500 U kit) or 40 mL (1000 U kit) of diluent provided with the kit.

When reconstituted, the final concentration of drug product in Factor IX units will be in a range from 20-31 units/mL. The actual content of Factor IX, as measured in units of potency, is stated on the vial.

Co-administration of Kcentra and Vitamin K

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.

Home Dosing & Administration
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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