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Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo
Important Safety Information | Patient Site
Prescribing Information
    • Pharmacology
    • Mechanism of Action
    • Prophylaxis
    • On Demand
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Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo

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.

Prescribing Information
Important Safety Information | Patient Site

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  

Dosing for routine prophylaxis

For patients <12 years of age

The recommended starting dose of Esperoct® is 65 IU/kg twice weekly.

One simple dose:

65 IU/kg twice weekly—no dose adjustment needed and related PK testing required1,2  

65 IU/kg twice weekly routine prophylaxis in children

This regimen may be individually adjusted to less or more frequent dosing1   

43% fewer infusions

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

NHF’s Medical and Scientific Advisory Council

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

Dosing for minor/moderate bleeds in children

Major bleeds

Dosing for major bleeds in children

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

Dosing for perioperative management in children

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  

See dosing for adults & adolescents

Available in multiple vial sizes

Esperoct® is supplied in single-dose vials with color-coded caps to differentiate the dose strengths.1  

Available vial sizes
Esperoct® multiple vials

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® storage

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 storage

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.

Safety data icon

Count on the proven safety profile of Esperoct®.

View safety data

Reconstitute in just a few steps

Esperoct® attach, twist, mix

With MixPro®, it’s as quick as attach, twist, and mix.1  

See the steps

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:

  1. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  2. 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.
  3. Cafuir L and Kempton C. Current and emerging factor VIII replacement products for hemophilia A. Ther Adv Hem. 2017;8(10):303–313.
  4. National Hemophilia Foundation. MASAC recommendations concerning prophylaxis, #241. New York, NY: National Hemophilia Foundation; 2016.
  5. Eloctate® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020.
  6. Adynovate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2021.
  7. Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
Rare Bleeding Disorders
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