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Efficacy in surgical procedures
In a phase 3 study, Esperoct® was shown to provide effective perioperative bleed control.1
Fixed dosing for all surgeries.1,a,b
No need to calculate desired FIX activity levels to determine the appropriate dose.
adults and adolescents
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
Hampton et al (2017)
pathfinder 3 phase 3 surgery trial
Patients: Previously treated males aged ≥12 years with severe hemophilia A (FVIII activity level <1%) who were scheduled for major surgery and had at least 150 exposure days to FVIII products other than Esperoct®.2
Study design: Open-label, nonrandomized trial including 45 major surgeries among 33 patients. Patients received a preoperative dose of Esperoct®, established at a screening visit 0-3 weeks prior to surgery. Intraoperative and postsurgery dosing was at the investigators’ discretion. Monitoring for FVIII activity was daily during postoperative days 1–6, at least once during days 7–14 and once weekly beyond day 14, with Esperoct® dosage adjusted to follow World Federation of Hemophilia guidelines for FVIII activity levels for major surgery.1,2
Primary endpoint: Evaluating the hemostatic effect of Esperoct® following surgery, using a four-point scale (none, moderate, good, and excellent). Treatment success was defined as excellent or good bleed control.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.