Efficacy in surgical procedures
In a phase 3 study, Esperoct® was shown to provide effective perioperative bleed control.1

Simple perioperative dosing.1
No need to calculate desired FIX activity levels to determine the appropriate dose.
Pre-operative for all surgeriesa,b
aPerioperative dosing recommendation for pediatric patients is 65 IU/kg.1
bFor minor surgeries, additional dose(s) can be administered after 24 hours; for major surgeries, additional doses can be administered every 24 hours in the first week and then every 48 hours in the second week.1
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Study design
pathfinder 3 phase 3 clinical trial (Hampton, et al):
A phase 3, open-label, nonrandomized trial to assess the hemostatic efficacy of Esperoct® during major surgery in 33 previously treated adolescents and adults with hemophilia A who underwent 45 major surgeries, 41 of which were orthopedic (15 joint replacements, 9 arthroscopic orthopedic interventions, and 17 classified as “other” orthopedic interventions) based on interim data. The success rate in bleed control during surgery was evaluated on a 4-point scale of excellent, good, moderate, or poor. Treatment success was defined as excellent or good bleed control.1,2
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:
- Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
- Hampton K, Chowdary P, Dunkley S, et al. First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A. Haemophilia. 2017;23(5):689-696.