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Novoeight®–proven reliability in treating bleeds.

Data from one of the largest clinical trial programs of a recombinant FVIII showed Novoeight® to be effective in adults, adolescents, and children. The guardian™ clinical trial program included 238 previously treated patients and more than 130,000 exposure days.1-3

Proven effective in adults, adolescents, and children.

Novoeight® demonstrated effective, long-term prophylaxis by continuing to reduce bleeds.5,a
 

Median ABR

All patients

(0–65 years old)

3.1 (N=213)

median bleeds per year4,a


Children

(≤11 years old)

3.0 (N=63)

median bleeds per year2,b


Results of an initial clinical trial studying the effectiveness and safety in children


Long-term safety trial

1.6 (N=197)

median bleeds per year4,a


The majority of patients continued in a safety extension trial
 

ABR=annualized bleed rate.
 

Results from guardian™1 and guardian™3 pivotal trials1,2,6,b,c,d

Bleeds controlled with 1 or 2 infusions

Adolescents and adults

Aged 12-65 | N=150

Children

Aged 0-11 | N=63

Hemostatic success rate in major and minor surgeriesd

All patients

Bleeds controlled with 1 or 2 infusions

Adolescents and adults

Aged 12-65 | N=150

Children

Aged 0-11 | N=63


Hemostatic success rate in major and minor surgeriesd

All patients

aguardian™2: a phase 3b, non-randomized, open-label extension trial investigating the long-term safety and efficacy of turoctocog alfa in 213 previously treated males of all ages with severe hemophilia A. Of the 207 patients on prophylaxis, accumulated patient-years on prophylaxis was 730.8.5
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™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
d
A 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.6

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 program included 238 previously treated patients (PTPs) and more than 130,000 exposure days.1-3

 

fPTPs who participated in the guardian 1, 2 and 3 clinical trials.1-3

Designed with molecular precision.

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


Novoeight® offers consistency from batch to batch.7,8


Dosing guidelines for Novoeight®.

Novoeight® prefilled syringe


Refer to our dosing tables for recommendations.
 


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Selected Important Safety Information

Contraindications

  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins

Warnings and Precautions

  • 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 on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.

  • Novoeight® is not indicated for the treatment of von Willebrand disease

Important Safety Information

Contraindications

  • Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins

Warnings and Precautions

  • 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. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors

Adverse Reactions

  • The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia.

Please click here for Prescribing Information

References

  1. 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.
  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 S, Janic D, Ozelo MC, et al. End-of-trial results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Poster presented at: International Society on Thrombosis and Haemostasis 26th Biennial Congress Meeting; July 8-13, 2017; Berlin, Germany.
  4. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  5. Lentz SR, Janic D, Kavakli K, et al. Long-term safety and efficacy of turoctocog alfa in prophylaxis and treatment of bleeding episodes in severe haemophilia A: Final results from the guard™2 extension trial. Haemophilia. 2018 Nov;24(6):e391-e394.
  6. 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.
  7. Christiansen ML, Balling KW, Persson E, Hilden I, et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia. 2010;16:878-887.
  8. 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.