Because he wants to feel protected, Novoeight® takes deliberate steps toward purity

To offer pathogen safety for your patient, Novoeight®:

  • Undergoes an extensive 5-step purification process that employs state-of-the-art double nanofiltration1-3
  • Is manufactured without any animal- or human-derived components 2
     
Friends living with hemophilia A walking on the beach.


David, 22 years old; Dylan, 24 years old; and Malcolm, 18 years old, live with hemophilia A.

The first recombinant FVIII to use state-of-the-art double nanofiltration

Novoeight® is the first recombinant FVIII to employ two 20-nm filters.3

Novoeight is the first recombinant FVIII to employ double 20-nm filters


 



 

Novoeight safety results

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.2

Novoeight conversation guide

Supporting the conversation

Get useful tools and information that can help you talk with your patient about Novoeight®, and discuss all the ways it may fit into his world.


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. Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.; 2014. 3. Data on file, at Novo Nordisk Inc.; Plainsboro, NJ. Nov 2012.


 



 

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.