Speed and less volume with Kcentra

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Shorter time to surgery with Kcentra vs plasma

The median time to surgery was ~5 hours faster with Kcentra (3.6 hours) vs plasma (8.5 hours).2
The median time to surgery was ~5 hours faster with Kcentra (3.6 hours) vs plasma (8.5 hours)2
Median time to surgery was 5 hours faster with Kcentra than for plasma

*ITT-E population.

Faster mean infusion time with Kcentra vs plasma

Less than 25 minutes mean infusion time for Kcentra vs over 2 hours for plasma.
Less than 25 minutes mean infusion time for Kcentra vs over 2 hours for plasma
Mean infusion time was 7 times faster with Kcentra than with plasma
Mean infusion time was 7 times faster with Kcentra than with plasma

*Mean infusion time was 21 min (±14 min) for Kcentra and 141 min (±113 min) for plasma.

Mean infusion time was 24 min (±32 min) for Kcentra and 169 min (±143 min) for plasma.

  • No need for thawing or ABO typing

Kcentra uses less volume and is more concentrated than plasma

Kcentra requires ~85% less volume and is ~25x more concentrated than plasma.8
Kcentra requires ~85% less volume than plasma
Mean infusion volume was 85% less for Kcentra than for plasma
Mean infusion volume was 85% less for Kcentra than for plasma

*Mean infusion volume was 90 mL (±32 mL) for Kcentra and 819 mL (±231 mL) for plasma.

Mean infusion volume was 105 mL (±37 mL) for Kcentra and 865 mL (±269 mL) for plasma.

Kcentra is ~25x more concentrated than plasma8
  • 3 vials of Kcentra (an average volume of 2500 IU administered as a single dose) are equal to 10–12 units of plasma
Kcentra 100mL
Kcentra
100 mL
10-12 units of plasma, 250mL per bag
Plasma
250 mL/bag
Top of Page Important Safety Information
Important Safety Information & Indications

Important Safety Information

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 and its variant (vCJD), cannot be completely eliminated.

Indications

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.

Please see full prescribing information for Kcentra.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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