KCENTRA Quick Guide vs CredibleMeds Mobile

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.

This CredibleMeds Mobile App supports the CredibleMeds.org website which maintains and posts lists of drugs in categories that reflect their ability to prolong the QT interval on the electrocardiogram and/or cause the life-threatening heart arrhythmia, torsades de pointes (TdP). The CredibleMeds Mobile App was developed for patients with Congenital Long QT Syndrome, healthcare professionals and research scientists in order to provide them with ready access to the most up-to-date version of the CredibleMeds lists of drugs. The App also provides background information on the categories of drug risk and explains the relationship between QT prolongation and TdP. For healthcare professionals and research scientists, the QTdrugs Lists can be used to identify which drugs can cause QT prolongation or TdP. For patients with Congenital Long QT Syndrome, the drugs and risk categories are described and presented separately as the Drugs to Avoid in cLQTS.