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Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo
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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

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)
Esperoct® Mechanism of Action
See how Esperoct® achieves hemostasis in patients with hemophilia A and uses PEGylation to extend half-life.
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Prescribing Information | Important Safety Information
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 

Review half-life data
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

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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


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Esperoct® was shown to provide effective prophylaxis.1

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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.
Rare Bleeding Disorders
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