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For your patients with hemophilia A who are looking for a product that’s ready to go, proven effective, and has an established safety profile, 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 are looking for a product that’s ready to go, proven effective, and has an established safety profile, 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 1.4 bleeds in the long-term safety trial.1
Read the data

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Portable

To support a patient's busy lifestyle, Novoeight® offers a higher degree of stability—it's the only SHL 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 for PTPs and over 9 years of clinical experience.2,b
See the study results

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Access

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

rFVIII=recombinant factor VIII.
PTP=previously treated patient.
aCompared with other selected rFVIII SHL and EHL products.3-12
b
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).2

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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 for any standard half-life treatment.1,c It's the storage flexibility they need to help them stay on the go.


cCompared with other standard half-life recombinant FVIII products.3-8


Peter
lives with hemophilia A.
 

Do you have patients who could benefit from a rFVIII with an extended half-life? 

If so, consider Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei]. With one simple 50 IU/kg dose every 4 days,d Esperoct® can deliver high trough levelse,f and a low median ABRe for adolescent and adult prophylaxis patients.13 Next time you see a hemophilia A patient, consider Esperoct®. It might be right for them.

Please click here for Esperoct® Prescribing Information and see Important Safety Information at the bottom of the page.

ABR=annualized bleed rate.
dRegimen can be individually tailored to less or more frequent dosing based on bleeding episodes.13
e
In a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct® were evaluated in PTPs aged ≥12 years with severe hemophilia A. Single-dose PK studies were performed in 42 adults after receiving Esperoct® 50 IU/kg; 175 PTPs received routine prophylaxis (50 IU/kg Q4D) for 76 weeks and 12 adults elected to be treated on demand during the main phase. Treatment-requiring bleeds were reported by patients through diaries. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL.13, 14
f
Steady-state FVIII activity profiles were estimated in 143 patients using a one-compartment model with first-order elimination with PK parameters of clearance and volume of distribution.13

Novoeight® 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

 

 

Esperoct® Selected Important Safety Information

Contraindications
  • Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins
Warnings and Precautions
  • Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment

Indications and Usage

Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.

  • Esperoct® is not indicated for the treatment of von Willebrand disease

Important Safety Information

Contraindications
  • Do not use in patients who have known hypersensitivity to Esperoct® or its components, including hamster proteins
Warnings and Precautions
  • Hypersensitivity reactions, including anaphylaxis, may occur. Should hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate treatment
  • Development of neutralizing antibodies (inhibitors) has occurred. Perform an assay that measures Factor VIII inhibitor concentration if bleeding is not controlled with the recommended dose of Esperoct® or if the expected plasma Factor VIII activity levels are not attained
Adverse Reactions
  • The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions

Please click here for Prescribing Information

References

  1. Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
  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. Kogenate® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2019.
  4. Advate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
  5. Eloctate™ [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020.
  6. Adynovate® [package insert]. Westlake Village, CA: Baxalta US Inc., 2021.
  7. Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
  8. Xyntha® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2020.
  9. Nuwiq® [package insert]. Hoboken, NJ: Octapharma USA, Inc.; 2017.
  10. Kovaltry® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2016.
  11. Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2020.
  12. ReFacto® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2007.
  13. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  14. Giangrande P, Andreeva T, Chowdary P, et al. Clinical evaluation of glycoPEGylated recombinant FVIII: efficacy and safety in severe haemophilia A. Thromb Haemost. 2017;117(2):252-261.