![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo](/content/dam/novonordisk/novomedlink/logos/bleeding-disorders/esperoct.svg)
Bleed protection across all ages1,2: Children
Esperoct® is an extended half-life (EHL) rFVIII with a proven starting dose and the ability to individualize prophylactic dosing frequency based on your patient’s bleeding episodes.3
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Routine prophylaxis:
65 IU/kg twice weekly—no dose adjustment needed or related PK testing required3,4,a
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.1,2,6
5 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 go3,7-9,e
You have the flexibility to store Esperoct® up to 104 °F for up to 3 months.3,e
ePrior 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 or up to 24 hours in the refrigerator.3
Please see Prescribing Information for complete storage instructions.
Count on the clinical trial experience of Esperoct®.
Reconstitute in just a few steps
With MixPro®, it’s as quick as attach, twist, and mix.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
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:
- 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; 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(02):252-261.
- National Hemophilia Foundation. MASAC recommendations concerning prophylaxis, #241. New York, NY: National Hemophilia Foundation; 2016.
- 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.
- Eloctate® [package insert]. Bioverativ Therapeutics Inc.; 2023.
- Adynovate® [package insert]. Lexington, MA: Baxalta US Inc.; 2023.
- Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.