KCENTRA Quick Guide vs PedsGuide

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.

In our commitment to creating a world of well-being for all children, Children’s Mercy Kansas City has created PedsGuide as a means for evidence-based pediatric clinical support guidelines to be available to health care providers. PedsGuide is a multi-module pediatric clinical support tool intended for use only by professional health care providers and emergency personnel for informational and educational purposes. *Each module provides users with a step-by-step interactive clinical decision support process, including reference material and/or contextually relevant information based on evidence-based practice and expert opinion routinely used in clinical practice, to assist in management of various acute illnesses in children. The modules have been designed and optimized by an interdisciplinary team of clinicians, pharmacists, medical librarians, Human Factors scientists, and innovations professionals. Human Factors methodology was leveraged to guide interfaces that provide rapid access to information and assessment tools, which facilitate an efficient aid for care management while decreasing cognitive load for the user. Additionally, for users who seek care for patients at The Children’s Mercy Hospital, PedsGuide features a quick-call feature to contact the Children’s Mercy Contact Center and Critical Care Transport Team in our service area. *While PedsGuide is a helpful tool, it is not intended to replace the independent judgment and evaluation of health care providers and emergency personnel. Healthcare providers and emergency personnel should not rely primarily on the tool to make a clinical diagnosis or treatment decision. Children's Mercy is not responsible for the correctness of any action you take based upon your use of PedsGuide.