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Routine prophylaxis: 4 days to the next dose
For patients ≥12 years of age
The recommended starting dose of Esperoct® is 50 IU/kg every 4 days.
Routine prophylaxis:
50 IU/kg every 4 days—no dose adjustment needed or related PK testing required1,3
This regimen may be individually adjusted to less or more frequent dosing based on bleeding episodes.3
In adults and adolescents:
a50% fewer if previously dosed every other day; 40% fewer if previously dosed 3x/week.
Esperoct® also may be dosed to achieve a specific target Factor VIII activity level, depending on the severity of hemophilia, for on-demand treatment/control of bleeding episodes, or perioperative management.
To achieve a specific target Factor VIII activity level, use the following formula:
Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5
Individualized prophylaxis frequency based on bleeding episodes
Esperoct® 50 IU/kg every 4 days offers effective prophylaxis, but patients with an ABR >1 could benefit from dose and dosing interval individualization.4
Mean ABR reduction4,b,c
when switched from Q4D to twice-weekly dosing, in patients with an ABR >1 (n=30)b
bA subgroup analysis was performed in 71 patients who switched from Esperoct® 50 IU/kg every 4 days (Q4D) in pathfinder2 to 50 IU/kg twice weekly in pathfinder8.4
cIn the subgroup analysis, 30 of the 71 patients had a mean ABR >1 coming from pathfinder2. 90% of these patients demonstrated an improvement in ABR after transitioning to twice-weekly prophylaxis in pathfinder8. Three of these patients demonstrated an increase in ABR after transitioning to the new regimen, with a mean (SD) change in ABR of 2.67 (2.4).4
MASAC recommends prophylaxis for patients with severe hemophilia A.
MASAC recommends that prophylaxis be considered optimal therapy for individuals with severe hemophilia A (factor VIII <1%).
Prophylactic therapy should be instituted early (prior to the onset of frequent bleeding), with the aim of keeping the trough FVIII level above 1% between doses.5
MASAC=Medical and Scientific Advisory Council, National Hemophilia Foundation
Dosing for treatment of bleeding episodes
For patients ≥12 years of age
Minor/moderate bleeds
Major bleeds
dAdditional dose(s) may be administered after 24 hours for moderate bleeding and every 24 hours for major or life-threatening bleeding.3
Dosing for perioperative management
For patients ≥ 12 years of age
For all surgeries
eFor minor surgeries, additional dose(s) can be administered after 24 hours; for major surgeries, additional doses can be administered every 24 hours for the first week and then approximately every 48 hours until wound healing has occurred.3
Protection across all age groups with individualized prophylaxis frequency based on bleeding episodes.1,2,4
Dosing for routine prophylaxis
For patients <12 years of age
The recommended starting dose of Esperoct® is 65 IU/kg twice weekly.
Routine prophylaxis:
65 IU/kg twice weekly3,a
PK testing not required when starting therapy
This regimen may be individually adjusted to less or more frequent dosing based on bleeding episodes3
In children <12 years:
Because the clearance of FVIII products may be higher in children <12 years compared to adolescents/adults, higher and more frequent dosing may be required3
aEsperoct® also may be dosed to achieve a specific target Factor VIII activity level, depending on the severity of hemophilia, for on-demand treatment/control of bleeding episodes, or perioperative management. To achieve a specific target Factor VIII activity level, use the following formula: Dosage (IU) = Body Weight (kg) × Desired Factor VIII Increase (IU/dL or % normal) × 0.5
b43% fewer if previously dosed every other day; 33% fewer if previously dosed 3x/week.3
MASAC recommends prophylaxis for patients with severe hemophilia A.
MASAC recommends that prophylaxis be considered optimal therapy for individuals with severe hemophilia A (factor VIII <1%).
Prophylactic therapy should be instituted early (prior to the onset of frequent bleeding), with the aim of keeping the trough FVIII level above 1% between doses.5
MASAC=Medical and Scientific Advisory Council, National Hemophilia Foundation
Dosing for treatment of bleeding episodes
For patients <12 years of age
The recommended dose of Esperoct® to control bleeding episodes in children is 65 IU/kg.3
Minor/moderate bleeds
Major bleeds
cAdditional dose(s) may be administered after 24 hours for moderate bleeding and every 24 hours for major or life-threatening bleeding.3
Dosing for perioperative management
For patients <12 years of age
The recommended dose of Esperoct® for perioperative management in children is 65 IU/kg.3
Pre-operative for all surgeries
dFor 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 until wound healing has occurred.3
Bleed protection across all age groups with individualized prophylaxis frequency based on bleeding episodes.1,2,4
6 vial sizes for personalized treatment
Esperoct® is supplied in single-dose vials with color-coded caps to differentiate the dose strengths.3
Flexible storage for patients on the go3,6‑10,g
You have the flexibility to store Esperoct® up to 104 °F for up to 3 months.3,g
gPrior to reconstitution, Esperoct® can be stored from 36 °F to 46 °F for up to 30 months, at room temperature up to 86 °F for up to 12 months, or up to 104 °F for up to 3 months.3 See Prescribing Information for complete product storage information.
Storage temperature:
Esperoct® requires no refrigeration and can be stored at temperatures up to 104 °F for up to 3 months or up to 86 °F for up to 12 months.3
Storage after reconstitution:
Post-reconstitution, Esperoct® can be stored for use within 4 hours at up to 86 °F and up to 24 hours in the refrigerator.3
Please see Prescribing Information for complete product storage information.
Count on the clinical trial experience of Esperoct®.
Reconstitute in just a few steps
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Study design
Lentz et al4 (2022)
pathfinder8 phase 3 extension trial
Patients: Previously treated males (n=160) with severe hemophilia A (FVIII activity <1%) participating in pathfinder2 (n=102) and pathfinder5 (n=58) trials.
Study design: Multicenter, multinational, open-label, nonrandomized, interventional trial. Patients received Esperoct® prophylaxis dosed every 7 days (Q7D), twice weekly (BIW), or three times weekly (TIW), with dosing interval based on previous regimen and bleeding tendency. All patients on the Q7D regimen were aged ≥12 years, and the dose was 75 IU/kg. Dosing for BIW was 50 IU/kg (patients aged ≥12 years) or 60 IU/kg (patients aged <12 years). TIW dosing was 50 IU/kg (all ages).
Primary endpoint: Number of reported adverse events.
Secondary endpoints: Efficacy endpoints included number of treated bleeds on prophylaxis, pre-dose FVIII activity levels on prophylaxis, and treatment satisfaction. A secondary safety endpoint was the incidence of FVIII inhibitors.
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, Abdul 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(suppl 1):5-14.
- Šaulytė Trakymiene S, Economou M, Kenet G, Landorph A, Shen C, Kearney S. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: final results from pathfinder5. J Thromb Haemost. 2020;18(suppl 1):15-25.
- Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- 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.
- National Hemophilia Foundation. MASAC recommendations concerning prophylaxis for hemophilia A and B with and without inhibitors, #267. New York, NY: National Hemophilia Foundation; 2022.
- 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.
- Adynovate® [package insert]. Lexington, MA: Baxalta US Inc; 2023.
- Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2023.
- Altuviiio® [package insert]. Waltham, MA: Bioverativ Therapeutics Inc; 2023.
- Eloctate® [package insert]. Waltham, MA: Bioverativ Therapeutics Inc; 2023.
- Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.