0 INHIBITORS
CONFIRMED 1
20 -NM
FILTERS 3
FOR 12 MONTHS1
A recombinant factor VIII for today ’ s generation of people living with hemophilia A 1
Novoeight ® —
Reliable treatment made portable
years of clinical experience with Novoeight ® in PTPs 2 , a
a
PTP = previously treated patients .
Michael , 30 years old , lives with hemophilia A .
RELIABILITY
0 INHIBITORS
CONFIRMED 1
One of the largest clinical trials with 225 PTPs receiving 88,000 infusions b , c , d
TWO
PURITY
20 -NM
FILTERS 3
Employs state-of-the-art double nanofiltration
UP TO
PORTABILITY
86 o F
FOR 12 MONTHS1
Highest storage temperature for the longest duration e
Please see Prescribing Information for complete storage instructions . Visit Novoeightpro . com today to learn more .
b
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 . 1 c 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 ). 4
d 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 . 5 e
Compared with other recombinant FVIII products . 6-14
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 ; 2016 . 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 ; 19:691-697 . 3 . Data on file . Novo Nordisk Inc ; Plainsboro , NJ . 4 . 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 . 5 . Lentz SR , Cerqueira M , Janic D , Kempton C , 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 : e445-e449 . 6 . Kogenate ® [ package insert ]. Tarrytown , NY : Bayer HealthCare LLC ; 2014 . 7 . Advate ® [ package insert ]. Westlake Village , CA : Baxter Healthcare Corporation ; 2015 . 8 . Eloctate™ [ package insert ]. Cambridge , MA : Biogen Idec Inc .; 2016 . 9 . Adynovate ® [ package insert ]. Westlake Village , CA : Baxalta US Inc .; 2016 . 10 . Recombinate ® [ package insert ]. Westlake Village , CA : Baxter Healthcare Corporation ; 2010 . 11 . Xyntha ® [ package insert ]. Philadelphia , PA : Wyeth Pharmaceuticals Inc .; 2014 . 12 . Afstyla ® [ package insert ]. Kankakee , IL : CSL Behring LLC ; 2016 . 13 . Nuwiq ® [ package insert ]. Hoboken , NJ : Octapharma USA , Inc .; 2015 . 14 . ReFacto ® [ package insert ]. Philadelphia , PA : Wyeth Pharmaceuticals Inc .; 2007 .
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 . © 2018 Novo Nordisk Printed in the U . S . A . USA17BIO03711 January 2018