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Keep your patients protected with one simple dose
Esperoct® is an extended half-life (EHL) rFVIII that keeps dosing simple.1
Keep your patients protected with one simple dose
Esperoct® is an extended half-life (EHL) rFVIII that keeps dosing simple.1
One simple dose:
65 IU/kg twice weekly—no dose adjustment needed and related PK testing required1,2
This regimen may be individually adjusted to less or more frequent dosing1
With the extended half-life of Esperoct®, your pediatric patients may need up to 43% fewer infusionsa per year compared to standard half-life dosing regimens3
Because the clearance of FVIII products may be higher in children <12 years compared to adolescents/adults, higher and more frequent dosing may be required1
a43% fewer if previously dosed every other day; 33% 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
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.4
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.1
Dosing for treatment of bleeding episodes:
Minor/moderate bleeds
Major bleeds
bAdditional dose(s) can be administered every 24 hours for major or life-threatening bleeding.1
Dosing for perioperative management
For patients <12 years of age
The recommended dose of Esperoct® for perioperative management in children is 65 IU/kg.1
Pre-operative for all surgeries
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.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.1,5-7
Storage temperature:
Esperoct® requires no refrigeration and can
be stored at temperatures up to 104˚F
for up to 3 months or 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 proven safety profile of Esperoct®.
Reconstitute in just a few steps
With MixPro®, it’s as quick as attach, twist, and mix.1
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.
- 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.