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A Case for 4F-PCC: Mortality & Safety Data vs. Plasma

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A physician’s perspective on the risk of thromboembolic events and mortality and why choosing 4F-PCC over Plasma may benefit your patients.

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Important Safety Information

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  • Overview

    The largest study to date on 4F-PCC was conducted as an FDA postmarketing requirement in partnership between Kaiser Permanente and CSL Behring. The purpose of this long-term study was to compare the 45-day risk of thromboembolic events and all-cause mortality in adults with warfarin-associated major bleeding after treatment with KCENTRA®, Prothrombin Complex Concentrate (Human), or plasma. Take a deep dive into the data with Dr. Jennifer Caudle as she speaks with Dr. Michelle Kincaid, Trauma Surgeon and Director of Surgical Critical Care at Ohio Health Grant Medical Center in Columbus.

  • 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.

    KCENTRA is manufactured by CSL Behring GmbH and distributed by CSL Behring LLC.
    KCENTRA® is a registered trademark of CSL Behring GmbH.

    © 2023 CSL Behring
    USA-KCT-0212-JUL23

Schedule23 Apr 2024