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Efficacy in surgical procedures
In a phase 3 study, Esperoct® was shown to provide effective perioperative bleed control.2,3
The hemostatic efficacy of Esperoct® was assessed in 35 adolescent and adult patients with hemophilia A who underwent 49 major surgeries.3
in
patients
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patients
across
major sugical
procedures3
Fixed dosing for all surgeries.2,b,c
No need to calculate desired FVIII activity levels to determine the appropriate dose.2
adults and adolescents
bPerioperative dosing recommendation for pediatric patients is 65 IU/kg.2
cFor 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.2
Trial prescription program
Esperoct® may be right for your patients with hemophilia A who are interested in switching from their current standard or extended half-life FVIII product. Qualifying patients can now receive a trial prescription.h
To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.
hPatients who have been prescribed a Novo Nordisk hemophilia and rare bleeding disorder product for an FDA-approved indication, and who have commercial insurance, may be eligible to receive a limited supply of free product. Eligibility criteria and restrictions apply.
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
Giangrande et al (2017 and 2020)
pathfinder2 phase 3 clinical trial: main phase and extension
Patients: Previously treated males aged 12–66 years with severe congenital hemophilia A (FVIII activity <1%) and at least 150 exposure days to any FVIII products.1
Study design: Multinational, open-label, non-randomized trial evaluating safety, pharmacokinetics, and clinical efficacy of Esperoct® when used for prophylaxis and treatment of bleeds. During the main phase, 175 patients received routine prophylaxis (50 IU/kg every 4 days), and 12 adults elected to be treated on-demand. A subset of patients (n=150) continued on in extension phase part 1; 139 continued into the non-randomized extension part 2, with 113 completing the trial.1,5
Co-primary endpoints: Incidence of FVIII inhibitors ≥0.6 BU (Bethesda units) and ABR (annualized bleeding rate) for patients on a prophylaxis regimen.1
Hampton et al (2017) and Tosetto et al (2020)
pathfinder3 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 any FVIII products.3
Study design: Open-label, nonrandomized trial including 49 major surgeries among 35 patients. Patients received a preoperative dose of Esperoct®, established at a screening visit 0-3 weeks prior to surgery, two hours prior to the start of 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.3,4
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.3
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
- Temporary decrease in Factor VIII incremental recovery (IR) has been observed after Esperoct® infusion, within the first 5 exposure days, in previously untreated patients (PUPs) <6 years of age. During the decreased IR period, these subjects may have an increased bleeding tendency. If bleeding is not controlled with the recommended dose of Esperoct® and/or the expected Factor VIII activity levels are not attained and Factor VIII inhibitors are not detected, consider adjusting the dose, dosing frequency, or discontinuing Esperoct®
Adverse Reactions
- The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions. Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity.
Please click here for Esperoct® Prescribing Information.
References:
- 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.
- Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Tosetto A, Neff A, Lentz S, et al. Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials. Haemophilia.2020;00:1-9.
- 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.
- Giangrande P, Karim F, Nemes L, et al. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: final results from pathfinder2. J Thromb Haemost. 2020;18(1):5-14