Novoeight®–proven reliability in treating bleeds.

Data from one of the largest clinical trial programs of a recombinant FVIII to date showed Novoeight® to be effective in adults, adolescents, and children. The guardian™ Clinical Trial program included 225 previously treated patients with a total of 88,000 exposure days.1-3,a-d

Proven effective in adults, adolescents, and children.

Novoeight® demonstrated effective, long-term prophylaxis by continuing to reduce bleeds.3
 

Median ABR

All patients

(0–65 years old)

3.1 (N=213)


In initial clinical trials, patients who took Novoeight® had a median of 3.1 bleeds per year.4


Children

(≤11 years old)

3.0 (N=63)


In an initial clinical trial, children who took Novoeight® had a median of 3.0 bleeds per year.2


Safety extension trial

1.6 (N=197)


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.3,c


ABR=annualized bleed rate.
 

Results from guardian™1 and guardian™3 pivotal trials

Bleeds controlled with 1 or 2 infusions1,2,a,b

Adolescents and adults

Aged 12-65 | N=150

Children

Aged 0-11 | N=63

Hemostatic success rate in major and minor surgeries5,e

All patients

Bleeds controlled with 1 or 2 infusions1,2, a,b

Adolescents and adults

Aged 12-65 | N=150

Children

Aged 0-11 | N=63


Hemostatic success rate in major and minor surgeries5,e

All patients

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).1
bguardian™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).2
cguardian™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, 2013.3
dPatients with previous inhibitors were excluded from the trials. Individuals with hemophilia A may develop inhibitors to FVIII. Monitor patients taking Novoeight® for inhibitor formation.4
eA hemostatic response rated as “excellent” or “good” was considered treatment success. If hemostatic response was rated as “moderate” or “none,” the treatment was considered treatment failure. Missing data were included in the treatment failure category.5
 

What About Safety?

The guardian™ clinical trial program also studied the safety of Novoeight®, an important consideration when choosing a treatment for your patients. The guardian™ Clinical Trial program included 225 previously treated patients with a total of 88,000 exposure days.1-3,a-d

Designed with molecular precision.

Green (Novoeight®) and Blue (D-domain of vWF) molecules


Novoeight® offers consistency from batch to batch.6,7


Dosing guidelines for Novoeight®.

Novoeight® prefilled syringe


Refer to our dosing tables for recommendations.
 


Have a question? We’re here to help.

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Talk to a Novo Nordisk Representative about the services and resources available to you.
 

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 Prescribing Information.

References

  1. Lentz SR, Cerqueira M, Janie 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-e44.
  2. 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.
  3. 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.
  4. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2016.
  5. Santagostino E, Lentz SR, Misgav M, et al. Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials. Haemophilia. 2015;21(1):34-40.
  6. Christiansen ML, Balling KW, Persson E, Hilden I, et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia. 2010;16:878-887.
  7. Viuff D, Barrowcliffe T, Saugstrup T, Ezban M, Lillicrap D. International comparative field study of N8 evaluating factor VIII assay performance. Haemophilia. 2011; 17(4):695-702.