Novoeight ® — designed to support an active lifestyle
Is it time to reconsider your treatment for hemophilia A ?
MORE PATIENTS HAVE SWITCHED TO NOVOEIGHT ®
THAN TO ANY STANDARD
HALF-LIFE rFVIII SINCE LAUNCH a a
Based on data for Q2 2015-Q1 2016 ; accounts for net gains and losses of patients switching to and from standard half-life rFVIII available for at least one year . 1
Novoeight ® — designed to support an active lifestyle
0 inhibitors confirmedb , c
One of the largest clinical trials with no inhibitors confirmed in
225 previously treated patients b , d receiving
88,000 infusionsb
, c
Whether planning a trip or being active at home , Novoeight ® offers reliability .
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Please see Prescribing Information for complete storage instructions .
b guardian ™ 1 : a multicenter , multinational , open-label , single-arm efficacy 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 , efficacy , 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 efficacy 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
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 . Data on file . Novo Nordisk Inc ; Plainsboro , NJ . 2 . Lentz SR , Misgav M , Ozelo M , et al . Results from a large multinational clinical trial ( guardian ™ 1 ) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A : safety and efficacy . Haemophilia . 2013 ; 19 ( 5 ): 691-697 . 3 . Kulkarni R , Karim FA , Glamocanin S , et al . Results from a large multinational clinical trial ( guardian ™ 3 ) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A : safety , efficacy and pharmacokinetics . Haemophilia . 2013 ; 19 ( 5 ): 698-705 . 4 . Lentz SR , Cerqueira M , Janic D , et al . Interim results from a large multinational extension trial ( guardian™ 2 ) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A . Haemophilia . 2016 ; 22 ( 5 ): 1-5 . 5 . Novoeight [ package insert ]. Plainsboro , NJ : Novo Nordisk Inc ; 2015 .
Novo Nordisk Inc ., 800 Scudders Mill Road , Plainsboro , New Jersey 08536 U . S . A .
Novoeight ® is a registered trademark of Novo Nordisk Health Care AG . Novo Nordisk is a registered trademark of Novo Nordisk A / S . © 2016 Novo Nordisk All rights reserved . USA16HDM01372 November 2016