![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo](/content/dam/novonordisk/novomedlink/logos/bleeding-disorders/esperoct.svg)
Keep them protected with one proven dose
Esperoct® is an extended half-life (EHL) rFVIII with a proven starting dose and the ability to individualize to less or more frequent dosing based on bleeding episodes.1
Keep them protected with one proven dose
Esperoct® is an extended half-life (EHL) rFVIII with a proven starting dose and the ability to individualize to less or more frequent dosing based on bleeding episodes.1
Routine prophylaxis:
50 IU/kg every 4 days—no dose adjustment needed and related PK testing required1,2
This regimen may be individually adjusted to less or more frequent dosing based on bleeding episodes.1
With the extended half-life of Esperoct®, your patients may need up to 50% fewer infusionsa per year compared to standard half-life rFVIII treatments.3
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 pathfinder 2 to 50 IU/kg twice weekly in pathfinder 8.4
cIn the subgroup analysis, 30 of the 71 patients had a mean ABR >1 coming from pathfinder 2. 90% of these patients demonstrated an improvement in ABR after transitioning to twice-weekly prophylaxis in pathfinder 8. 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.1
Pre-operative 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.1
Available in multiple vial sizes
Esperoct® is supplied in single-dose vials with color-coded caps to differentiate the dose strengths.1
Room temperature stable up to 104˚F for up to 3 months
Esperoct® is the only EHL rFVIII that can be stored up to 104˚F for up to 3 months.1,6-8
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.1
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.1
Storage after reconstitution:
Post-reconstitution, Esperoct® can be stored
for use within 4 hours at up to 86˚F.1
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.1
Study design
Lentz et al4 (2022)
pathfinder 8 phase 3 extension trial
Patients: Previously treated males (n=160) with severe hemophilia A (FVIII activity <1%) participating in pathfinder 2 (n=102) and pathfinder 5 (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
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.
- 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.
- Cafuir L and Kempton C. Current and emerging factor VIII replacement products for hemophilia A. Ther Adv Hem. 2017;8(10):303–313.
- 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, #241. New York, NY: National Hemophilia Foundation; 2016.
- Eloctate® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020.
- Adynovate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2021.
- Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.