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Novoeight® is designed for safety and purity.

Novoeight® has been shown to be safe and effective in pivotal trials.1

0 inhibitors were confirmed in a pivotal trial program with 242 previously treated patientsa-c receiving over 119,000 infusions

In a clinical trial of PUPs, 42.9% developed inhibitors.4,e

Novoeight® offers an established safety profile.

0 inhibitors were confirmed in a pivotal trial program with 242 previously treated patientsa-c receiving over 119,000 infusions.1,2,4,5,a-d

Results from guardian™1 and guardian™3 pivotal trials:a,b

  • Safety results consistent among adults, adolescents, and children1,2
  • No thromboembolic events occurred during the trials1,2
  • The most frequently reported adverse reactions in previously treated patients were injection site reactions (2.3%), increased hepatic enzymes (1.4%),1,f and pyrexia (0.9%)4
  • Adverse reactions reported during postmarketing period were similar to those observed during clinical trials.4


PUP=previously untreated patient
a
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).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
e59 PUPs with severe hemophilia A (factor VIII level ≤1%) received at least one dose of Novoeight® as part of either routine prophylaxis or on-demand treatment of bleeding episodes. Patients developed inhibitors with a mean of 14.1 exposure days at the time of the first positive inhibitor test. High risk genetic mutations were identified in 91.7% of the overall inhibitors and 93.3% of the high titer inhibitors.4
f
All patients who reported increased hepatic enzymes had hepatitis C at screening.1

Designed with purity in mind.

Novoeight® is manufactured without the addition of any human- or animal-derived protein in the cell culture process, purification, or final formulation.4,6,e It is the first recombinant FVIII to employ double nanofiltration as part of a 5-part purity process, which minimizes the risk of viral and protein contamination.7-9

Molecular-level detergent inactivation graphic


Detergent Inactivation
Helps eliminate enveloped viruses

Immunoaffinity chromatrography graphic


Immunoaffinity Chromatography

Uniquely selects intact molecules

Molecular-level anion-exchange chromatography graphic


Anion-exchange Chromatography
Separates molecules from impurities, based on their charge

Molecular-level double nanofiltration graphic


Double Nanofiltration
Removes small pathogens, reducing nonenveloped viruses

Molecular-level gel-filtration graphic


Gel Filtration

Reduces FVIII multimers


g
Produced by recombinant DNA technology in Chinese hamster ovary cells.

What are the latest recommendations?

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) recommends recombinant products as a first-line therapy.10

MASAC recommendations for patients

Patient: Rare Bleeding Disorder
MASAC Recommendation: Recombinant Product if Available


Patient: Previously Treated Patient with Hemophilia A or B
MASAC Recommendation: Recombinant Product


Patient: Previously Untreated patient with Hemophilia A
MASAC Recommendation: Recombinant FVlll Product or Plasma-Derived VIII Product Containing von Willebrand Factor

Designed with molecular precision.

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


Novoeight® offers consistency from batch to batch.11,12
 


Dosing guidelines for Novoeight®.

Novoeight® prefilled syringe


Refer to our dosing tables for recommendations.
 


Have a question? We’re here to help.

Five standing human silhouettes


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

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 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-e449.
  4. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2018.
  5. Lejniece S, Martín-Salces M, Matytsina I, et al. Safety of turoctocog alfa for prevention and treatment of bleeds in patients with severe haemophilia A: final results from the guardian™2 trial. Poster presented at: 10th Annual Congress of the European Association of Hemophilia and Allied Disorders; February 1-3, 2017; Paris, France.
  6. Iorio A, Puccetti P, Makris M. Clotting factor concentrate switching and inhibitor development in hemophilia A. Blood. 2012; 120(4):720-727.
  7. Santagostino E. A new recombinant factor VIII: from genetics to clinical use. Drug Des Devel Ther. 2014;8:2507-2515.
  8. Tiede A, Klamroth R, Oldenburg J. Turoctocog alfa (recombinant factor VIII). Hamostaseologie. 2015;35(4):364-371.
  9. Data on file Novo Nordisk Inc; Plainsboro, NJ.
  10. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders. https://www.hemophilia.org/sites/default/files/document/files/masac253.pdf
  11. Christiansen ML, Balling KW, Persson E, Hilden I, et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia. 2010;16:878-887.
  12. 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.