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Medical Information | Non-US Health Care Professionals
Important Safety Information | Patient Site
Prescribing Information
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

Talk to us about Esperoct®.

Extended half-life for fewer infusionsa

With Esperoct®, your patients with hemophilia A may need up to 50% fewer infusions per yeara compared to standard half-life (SHL) dosing regimens.

a50% fewer for adults and adolescents if previously dosed every other day; 40% fewer if previously dosed 3x/week.

Bradley has
hemophilia A
and uses
Esperoct®.

Bradley has
hemophilia A
and uses
Esperoct®.

How does Esperoct® achieve hemostasis in patients with hemophilia A and extend half-life using PEGylation?

Prescribing Information | Important Safety Information
Esperoct® Mechanism of Action
(6:15)
PEGylation technology

Extending half-life through PEGylation

Esperoct® extends half-life by conjugating a 40-kDa polyethylene glycol residue to an O-linked glycan in the truncated B-domain of rFVIII.1-3 

Esperoct® multiple vials

Esperoct® is a recombinant factor VIII treatment

Esperoct® is made without human blood, plasma, or proteins. According to MASAC, recombinant factor VIII products are a recommended treatment of choice for patients with hemophilia A.1,4,b

bA possible exception is for newly diagnosed patients, which should be further discussed with the healthcare provider. Please refer to MASAC for full recommendations.4

Prophylaxis icon

Esperoct® was shown to provide effective prophylaxis.1

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Esperoct® package

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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
  • Temporary decrease in Factor VIII incremental recovery (IR) has been observed after Esperoct® infusion, within the first 5 exposure days, in previously untreated patients (PUPs) <6 years of age. During the decreased IR period, these subjects may have an increased bleeding tendency. If bleeding is not controlled with the recommended dose of Esperoct® and/or the expected Factor VIII activity levels are not attained and Factor VIII inhibitors are not detected, consider adjusting the dose, dosing frequency, or discontinuing Esperoct®

Adverse Reactions

  • The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions. Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity.

Please click here for Esperoct® Prescribing Information.

References:

  1. Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc. 
  2. Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013;11(4):670-678. 
  3. 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. 
  4. National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and selected disorders of the coagulation system, #284. New York, NY: National Hemophilia Foundation; 2024.