KCENTRA Quick Guide vs IDSA Practice Guidelines

Please see the Kcentra® app information below. 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 made from human blood and may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 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. ------------------------------------ The Kcentra App provides fast access to helpful tools and information from the Kcentra website without the need for an internet connection. APP FEATURES: • Dosing calculator and guidelines • Reconstitution instructional video and step-by-step guide • Administration guidelines • Patient monitoring information • Customer support information • Product reimbursement information • Product overview • Notification center • Personal bookmarking system Please see full Prescribing Information and Important Safety Information, including boxed warning at www.Kcentra.com.

Access the Infectious Diseases Society of America (IDSA) guidelines app anytime, anywhere! Download the app today and stay up-to-date on IDSA clinical guidelines, interactive tools, and new resources. The app contains features to search through guidelines, bookmark important pages and take notes on key information. Visit the IDSA app for new guidelines that are released throughout the year and new updates to existing guidelines. Disclaimer: The Infectious Diseases Society of America (IDSA) provides this app (“App)” for health care professionals only, and not the general public. The App is provided for informational purposes only, and it is not intended to provide medical or treatment advice and may not be treated as such by the user. As such, this App may not be relied upon for the purposes of medical diagnosis or as a recommendation for medical care or treatment. The information on this App is not a substitute for professional medical advice, diagnosis or treatment. All content, including text, graphics, images and information, contained on or available through this App is for general information purposes only.