![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo](/content/dam/novonordisk/novomedlink/logos/bleeding-disorders/esperoct.svg)
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
Have questions about efficacy or looking for patient resources?
Support for your patients.
Novo Nordisk provides resources to help your patients start on Esperoct®.
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.