Because he’s looking ahead, Novoeight® delivers the reliability he needs

Your patient wants a treatment he can count on—and so do you. Review data from a pivotal trial that demonstrates the efficacy of Novoeight®.1

Boy with hemophilia A


Julian, 13 years old, lives with hemophilia A.


 



 

Proven safe in one of the largest clinical trials of a recombinant FVIII to date1

 Novoeight clinical trial results showing 0 inhibitors in 213 treated patients.


 



 

Delivers reliable bleed control

Novoeight® is indicated for the control and prevention of bleeding, perioperative management, and routine prophylaxis in patients with hemophilia A.1 It has been proven effective in adults, adolescents, and children in clinical trials.1-3
  

Charts illustrating bleeds controlled rate for Novoeight patients. Homeostatic success rate is 100%


 



 

Offers efficacy he can count on

Novoeight® has been proven to control bleeds in patients taking prophylactic treatment.1

Novoeight clinical trials results.


In initial clinical trials, patients who took Novoeight® had a median of 3.1 bleeds per year.1

Novoeight clinical trials results.


The majority of patients continued in a safety extension trial. Results from an interim analysis showed that patients had a median of 1.6 bleeds per year.4,5,c

ABR=annualized bleeding rate.

aguardian™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
b
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, 2013.4,5
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.1
e
A hemostatic response rated as “excellent” or “good” was considered treatment success. A hemostatic response rated as “moderate” or “none” was considered treatment failure. Missing data were included in the treatment failure category.1-3


 



 

Novoeight clinical trials results.

Supporting the conversation

Get useful tools and information that can help you talk with your patient about Novoeight®, and discuss all the ways it may fit into his world. 


 



 

Novoeight clinical trials results.

Safety first

The safety profile of Novoeight® is supported by data from one of the largest pivotal trials of a recombinant FVIII to date, which included 213 previously treated patients.1

Novoeight clinical trials results.

Getting him started

Connect to resources that can help make his start a successful one.


References: 1.
Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. 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. Data on file, Novo Nordisk Inc.; Plainsboro, NJ. Common technical document summaries (NN001444774), Mar 2013. 5. Lentz, S. R., 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 22.5 (2016).


 



 

Selected 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.

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 click here for Novoeight® Prescribing Information.