Because he has high standards for his FVIII treatment, now there’s Novoeight®

Your patient demands a lot—from themselves, from you as their healthcare provider, and from their hemophilia treatment. That is why Novo Nordisk took such deliberate steps in manufacturing Novoeight®.

Man with hemophilia A walking on the beach


Malcolm, 18 years old,
lives with hemophilia A.


 



 

Designed for reliability with molecular precision

Novoeight® is precisely truncated to 21 amino acids in its B-domain for homogeneity.1,a

FVIII analyzed by SDS-PAGE

SDS-PAGE gel comparison adapted from Thim et al and Kristensen et al.1,2

HC=heavy chain; LC=light chain; SDS-PAGE=sodium dodecyl sulfate polyacrylamide gel electrophoresis.


 



 

D-domain of vWF and Novoeight®


vWF=von Willebrand factor.

Tyrosine sulfation supports high-affinity binding to vWF3,4

  • Binding to vWF has been shown to protect FVIII from premature clearance and degradation 3,4
  • Novoeight® is >99% sulfated at Tyr-16801,5,6
  • The clinical significance of the degree of tyrosine sulfation has not been established


 



 

Novoeight® working like FVIII he needs scheme

Novoeight® works like the FVIII he needs

  • Precise manufacturing process targets and selects molecules with fully intact A2 domains1
  • Similar to endogenous FVIII in its active form, ensuring effective physiologic activity1,7


 



 

Novoeight® hemophilia A medicine vials

Consistent from batch to batch6,7

  • Consistency is measurable by standard assays8,b


 



 

Novoeight Safety Profile

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.7


 

The Novoeight Start Guide

Getting him started

Connect to resources that can help him have a successful start with Novoeight®.


a
This study compared turoctocog alfa with commercially available recombinant FVIII products using SDS-PAGE and Western blotting.1
b
Standard assays can be used to reliably measure Novoeight® in plasma without the need for a separate standard.8

References: 1. Thim L, Vandahl B, Karlsson J, et al. Purification and characterization of a new recombinant factor VIII (N8). Haemophilia. 2010;16(2):349-359. 2. Kristensen AK, Kjalke M, Klausen NK, Ezban M, Vad K. Structural comparison of a new recombinant factor VIII molecule, turoctocog alfa, and commercially available FVIII products. Poster presented at: XXIV Congress of the International Society of Thrombosis and Haemostasis (ISTH); June 29-July 4, 2013; Amsterdam, The Netherlands. 3. Leyte A, van Schijndel HB, Niehrs C, et al. Sulfation of Tyr1680 of human blood coagulation factor VIII is essential for the interaction of factor VIII with von Willebrand factor. J Biol Chem. 1991;266(2):740-746. 4. Michnick DA, Pittman DD, Wise RJ, Kaufman RJ. Identification of individual tyrosine sulfation sites within factor VIII required for optimal activity and efficient thrombin cleavage. J Biol Chem. 1994;269(31):20095-20102. 5. Nielsen PF, Bak S, Vandahl B. Characterization of tyrosine sulphation in rFVIII (turoctocog alfa) expressed in CHO and HEK-293 cells. Haemophilia. 2012;18(5):e397-e398. 6. Christiansen ML, Balling KW, Persson E, et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia. 2010;16(6):878-887. 7. Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. 8. Viuff D, Barrowcliffe TW, Saugstrup T, et al. International comparative field study of N8 evaluating factor VIII assay performance. Haemophilia. 2011;17(4):695-702.


 



 

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.