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KEEP THEM PROTECTED WITH ONE SIMPLE DOSE

KEEP THEM PROTECTED WITH ONE SIMPLE DOSE

Esperoct® is an extended half-life (EHL) rFVIII that keeps dosing simple.1

ROUTINE PROPHYLAXIS: 4 DAYS TO THE NEXT DOSE

For patients ≥12 years of age

The recommended dose of Esperoct® is 50 IU/kg every 4 days.

With the extended half-life of Esperoct®, your patients may need up to 50% fewer infusionsb per year compared to standard half-life rFVIII treatments.

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

aBased on bleeding episodes.
b50% 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

With the extended half-life of Esperoct®, your patients may need up to 50% fewer infusionsb per year compared to standard half-life rFVIII treatments.

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 or <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.2

MASAC=Medical and Scientific Advisory Council, National Hemophilia Foundation

DOSING FOR TREATMENT OF BLEEDING EPISODES

For patients ≥12 years of age

Esperoct® provides effective bleed control with 1 simple dose.1

cAdditional dose can be administered every 24 hours for major or life-threatening bleeding.1

DOSING FOR PERIOPERATIVE MANAGEMENT

For patients ≥12 years of age

Esperoct® provides effective perioperative control with 1 simple dose.1

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.1

DOSING FOR ROUTINE PROPHYLAXIS

For patients <12 years of age

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

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 regimens.3

  • 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

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 regimens.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 or <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.2

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

bAdditional dose 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

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

FACTOR VIII MONITORING

Factor VIII activity assay results may be significantly affected by the type of aPTT reagent, which can result in over- or under-estimation of FVIII activity. Esperoct® FVIII activity levels and inhibitor testing is available through the Novo Nordisk Lab Program, using validated assays in compliance with CAP/CLIA regulations.

To activate your Labcorp account and participate in the program, download and complete the form, then email it to fixsupport@labcorp.com.

Please see Prescribing Information for complete monitoring information.

AVAILABLE IN MULTIPLE VIAL SIZES

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

Esperoct® multiple vial sizes
Esperoct® multiple vial sizes

ROOM TEMPERATURE STABLE UP TO 104˚F FOR UP TO 3 MONTHS

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

Post-reconstitution, Esperoct® can be stored for use within 4 hours at up to 86˚F or within 24 hours when stored in the refrigerator.1,d

dDo not store post-reconstitution at temperatures above 86˚F.

Please see Prescribing Information for complete storage instructions.

Count on the proven safety profile of Esperoct®.

Reconstitute in just a few steps.

Esperoct® attach, twist, mix

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

Register to get the latest updates about Esperoct®

Register to get the latest updates about Esperoct®

Selected 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

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 Prescribing Information

References:

  1. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  2. National Hemophilia Foundation. MASAC recommendations concerning prophylaxis, #241. New York, NY: National Hemophilia Foundation; 2016.
  3. Cafuir L and Kempton C. Current and emerging factor VIII replacement products for hemophilia A. Ther Adv Hem. 2017;8(10):303–313.