The molecular precision of Novoeight® was designed to offer what he needs1,2

Novo Nordisk continues to support the bleeding disorders community with Novoeight®.

13-year old boy with hemophilia A


Julian, 13 years old, lives with hemophilia A.


 



 

D-domain of vWF and Novoeight®


vWF=von Willebrand factor.

Tyrosine sulfation supports high-affinity binding to vWF1,2

  • Binding to vWF has been shown to protect FVIII from premature clearance and degradation2,3
  • Novoeight® is >99% sulfated at Tyr-16801,4,5
  • The clinical significance of the degree of tyrosine sulfation has not been established


 



 

Novoeight medicine vials

Consistent from batch to batch5,6

  • Consistency is measurable by standard assays7,a


 



 

Novoeight Patient conversation guide

Talk with us

Connect with a local Novo Nordisk Representative to learn more about Novoeight®.

Novoeight start guide

Getting him started

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


aStandard assays can be used to reliably measure Novoeight® in plasma without the need for a separate standard.7

References: 1. 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. 2. 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. 3. 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. 4. Thim L, Vandahl B, Karlsson J, et al. Purification and characterization of a new recombinant factor VIII (N8). Haemophilia. 2010;16(2):349-359. 5. Christiansen ML, Balling KW, Persson E, et al. Functional characteristics of N8, a new recombinant FVIII. Haemophilia. 2010;16(6):878-887. 6. Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. . 7. Viuff D, Barrowcliffe TW, Saugstrup T, Ezban M, Lillicrap D. 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.