ASH Clinical News May 2015 | Page 17

A recombinant FVIII to prevent and control bleeding in people with hemophilia A1 Novoeight —designed to fit into his world ® Your patients are on their way to their next milestone, and they want more from their treatment.2 Introduce them to Novoeight®, an evolution in treatment that delivers reliability, purity, and portability.1,3 Michael, 30 years old, lives with hemophilia A. Visit NovoeightPro.com to learn how Novoeight® can fit into his world. Indications and Usage Novoeight® (Antihemophilic Factor [Recombinant]) is indicated for use in adults and children with hemophilia A for control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes. Novoeight® is not indicated for the treatment of von Willebrand disease. Important Safety Information Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins. Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment. Development of activity-neutralizing antibodies (inhibitors) may occur. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform an assay that measures factor VIII inhibitor concentration. The most frequently reported adverse reactions (≥0.5%) were injection site reactions, increased hepatic enzymes, and pyrexia. Please see brief summary of Prescribing Information on following page. References: 1. Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. 2. DiBenedetti DB, Coles TM, Sharma T, Pericleous L, Kulkarni R. Assessing patients’ and caregivers’ perspectives on stability of factor VIII products for haemophilia