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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo

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.

Prescribing Information
Important Safety Information | Patient Site

Count on a proven safety profile

The safety of Esperoct® has been studied across 5 prospective, multi-center clinical trials.1  

Count on a proven safety profile

The safety of Esperoct® has been studied across 5 prospective, multi-center clinical trials.1  

Esperoct® adult walking outside

Esperoct® has been studied in:

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Esperoct® study design
  • Observed inhibitor development is consistent with the rate reported in epidemiologic studies (0.15 per 100 patient years)3
    • One PTP with an intron 22 inversion developed a FVIII inhibitor1,2,a  
  • No development of neutralizing anti-PEG antibodies nor hypersensitivity to PEG1,b

aAn 18-year-old African-American male with an intron 22 inversion developed a low titer inhibitor after 93 Esperoct® exposure days that subsequently rose to 13.5 Bethesda units, prompting withdrawal from the study. There was no change in efficacy, and the inhibitor eventually went away on its own (without use of ITI).2
bAnti-PEG antibodies of no clinical consequence were detected in 45 subjects, 32 of whom had preexisting anti-PEG antibodies.1  

Adverse reactions

In clinical trials, the most frequently reported adverse reactions with incidence ≥1% were1:

Rash

5.2%

Injection site reactions

2.6%

Redness

1.9%

Itching (pruritus)

1.5%

Recombinant manufacturing

Esperoct® is a recombinant factor VIII treatment made without human blood, plasma, or proteins.1

What are the latest recommendations?

The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) names recombinant factor VIII products as the recommended treatment of choice for patients with hemophilia A.4,c

cA possible exception is for newly diagnosed patients, which should be further discussed with the healthcare provider. Please refer to MASAC for full recommendations.

Long-term safety results—pathfinder 84

  • 160 patients were treated for ~1.9 years
  • Most adverse events were mild or moderate and no safety issues observed with laboratory or vital signs parameters 
  • Longest exposure to Esperoct® was ~8.4 yearsd        

dComprising 6.3 years in pathfinder 2 and 2.1 years in pathfinder 8.4

Reconstitute in just a few steps

Esperoct® attach, twist, mix

With MixPro®, it’s as quick as attach, twist, and mix.1  

Starting patients on Esperoct®

Esperoct® package

Novo Nordisk offers support programs to help qualifying patients get started.

Selected Important Safety Information for Esperoct®

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 Esperoct® Prescribing Information.

References:
  1. Esperoct® Summary of Product Characteristics, Novo Nordisk, 2019.
  2. 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(02):252-261.
  3. Fischer K, Lassila R, Peyvandi F, et al. Inhibitor development in haemophilia according to concentrate. Thromb Haemost. 2015;114(4):670-675.
  4. Lentz SR, Kavalki K, Klamroth R, et al. Turoctocog alpha pegol (NB-GP) in severe hemophilia A: long-term safety and efficacy in previously treated patients of all ages in the pathfinder8 study. Res Pract Thromb Haemost. 2022;6(2):e12674.
  5. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #263. New York, NY: National Hemophilia Foundation; 2020.