ASH Clinical News December 2014 | Page 72

NovoSeven® RT responds with speed to control their bleeds1-3,a Want to watch a movie at my house tonight? OK. Sounds fun! My mom says she’ll order pizza, too. Sweet! See you in a few hours. BRAXTON Braxton has congenital hemophilia with inhibitors pd-aPCC=plasma-derived activated prothrombin complex concentrate. In patients with hemophilia A or B with inhibitors. Individual doses are compared and based on a 22-kg patient receiving a single dose (90 mcg/kg of NovoSeven® RT or 75 U/kg of pd-aPCC) for a joint bleed. c Patients are cautioned that the maximum injection or infusion rate of pd-aPCC must not exceed 2 units per kg of body weight per minute. d Median of 2 doses. Print-only content e Data from a randomized, double-blind, parallel-group, multicenter study of patients with hemophilia A or B with and without an inhibitor. Patients were given NovoSeven® at dosing intervals of 2 to 3 hours. Efficacy reflects the number of patients reporting excellent, effective, or partially effective results. Response was rated as “excellent” if patient demonstrated definitive relief of pain/tenderness and/or if there was a measurable decrease in the size of the bleed (or arrest of bleeding) in 8 hours or less. An “effective” response was measured by any of these 3 events occurring from 8 to 14 hours; a “partially effective” response either occurred after 14 hours or indicated detectable relief of pain/tenderness or decrease in bleeding.3 a b Indications and Usage NovoSeven® RT (Coagulation Factor VIIa [Recombinant]) is a coagulation factor indicated for: • Treatment of bleeding episodes and peri-operative management in adults and children with hemophilia A or B with inhibitors, congenital Factor VII (FVII) deficiency, and Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets • Treatment of bleeding episodes and peri-operative management in adults with acquired hemophilia Important Safety Information WARNING: THROMBOSIS • Serious arterial and venous thrombotic events following administration of NovoSeven® RT have been reported. • Discuss the risks and explain the signs and symptoms of thrombotic and thromboembolic events to patients who will receive NovoSeven® RT. • Monitor patients for signs or symptoms of activation of the coagulation system and for thrombosis. Warnings and Precautions • Serious arterial and venous thrombotic events have been reported in clinical trials and postmarketing surveillance. Please see additional Important Safety Information on facing page.