ASH Clinical News July 2017 V2 - Page 35

Is it time to reconsider your treatment for hemophilia A? Novoeight ® —designed to support an active lifestyle 0 225 inhibitors confirmed b,c S T N E I T A P E MOR ED H C T I W S E HAV GHT D I E O V O N TO O ANY STANDAR H a ® THAN T C INCE LAUN S I II V F r E HALF-LIF One of the largest clinical trials with no inhibitors confi rmed in previously treated patients b,d receiving c a Based on on data for for Q2 Q2 2015-Q1 2016; accounts for net and and losses of patients Based data 2015-Q1 2016; accounts for gains net gains switching to patients and from switching standard to half-life rFVIII standard available half-life for at least 1 year. 1 losses of and from rFVIII available for at one Nordisk year. Inc; Plainsboro, NJ. Reference: 1. Data on least file. Novo 1 88,000 Whether planning a trip or being active at home, Novoeight ® offers reliability. infusions b,c Visit today to learn more. Please see Prescribing Information for complete storage instructions. guardian ™ 1: a multicenter, multinational, open-label, single-arm effi cacy and safety trial in 150 patients (aged 12 to 65 years) with severe hemophilia A on a prophylactic treatment regimen who were exposed to turoctocog alfa for a mean of 85 exposure days (ranging from 11 to 172 exposure days). 2 guardian ™ 3: a multicenter, multinational, noncontrolled, open-label safety, effi cacy, and pharmacokinetic trial in 63 previously treated pediatric patients (aged 0 to 11 years) with hemophilia A in which patients were exposed to turoctocog alfa for a mean of 60 exposure days (ranging from 20 to 104 exposure days). 3 c guardian ™ 2: a prospective, open-label, uncontrolled extension trial investigating the safety and effi cacy of turoctocog alfa in 55 pediatric, 23 adolescent, and 122 adult patients with severe hemophilia A for a mean of 361.6 exposure days. The data cutoff date was December 31, 2013. 4 d Patients with previous inhibitors were excluded from the trials. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight ® for inhibitor formation. 5 b 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 B