For your patients with hemophilia A who value portability, reliability, and purity, Novoeight® offers all three.

Michael, 30 years old, lives with hemophilia A.


Michael,
30 years old, lives with hemophilia A. 

For your patients with hemophilia A who value portability, reliability, and purity, Novoeight® offers all three.


Novoeight® 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.1 Novoeight® is not indicated for the treatment of von Willebrand disease.


Novoeight® at a glance:

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Reliable

Effective bleed control, with a median of 3.1 bleeds per year1, on prophylaxis, in initial clinical trials.
Read the data

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Portable

To support his busy lifestyle, Novoeight® offers a higher degree of stability—it's the only rFVIII with stability up to 104°F for up to 3 months.1,a    
Learn about portability

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Safety

Proven safety profile, with 0 inhibitors confirmed in previously treated patients, in one of the largest clinical trial programs of a FVIII.2-4,b-d 
See the study results

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Access

Is he covered? Novo Nordisk is working to improve insurance access for your patients.
Find out about access

rFVIII=recombinant factor VIII.
aCompared with other recombinant FVIII products.5-14
bguardian™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).2
cguardian™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).3
d
guardian™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, 2013.4

Popular education for your patients.

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Do your patients want a portable treatment?

Novoeight® offers stability up to 104˚F for up to 3 months before reconstitution, plus the longest room temperature storage time after reconstitution.1,e It's the storage flexibility they need to help them stay on the go.


e
Compared with other recombinant FVIII products.5-14


Peter
lives with hemophilia A.
 

Featured professional education.

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  • Professional Brochure

    This brochure will help you understand the needs and challenges patients face as they transition through key life milestones.

  • Counsel the Switch

    This tool can help you educate patients about Novoeight®, with information about the product attributes, and guidance for addressing concerns.

  • Now on MedTalks

    Dr. Tarantino sits down with Team Novo8™ member Tammy Davenport to put women with hemophilia in the spotlight. Tune in to hear them discuss the need for better comprehensive care and treatment options for female patients and how they're raising awareness.

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 Prescribing Information.

References

  1. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2018.
  2. 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.
  3. 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.
  4. 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.
  5. Kogenate® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2016.
  6. Advate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2016.
  7. Eloctate™ [package insert]. Cambridge, MA: Biogen Idec Inc.; 2017.
  8. Adynovate® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2017.
  9. Helixate® [package insert]. Kankakee, IL: CSL Behring; 2016.
  10. Xyntha® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2014.
  11. Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2017.
  12. Nuwiq® [package insert]. Hoboken, NJ: Octapharma USA, Inc.; 2017.
  13. ReFacto® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2007.
  14. Kovaltry® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016.