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EXTENDED HALF-LIFE FOR FEWER INFUSIONSa

EXTENDED HALF-LIFE FOR FEWER INFUSIONSa

With Esperoct®, your hemophilia A patients 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.

ESPEROCT® MECHANISM OF ACTION

Esperoct®, a glycoPEGylated form of recombinant Factor VIII, temporarily replaces the missing coagulation Factor VIII needed for effective hemostasis in congenital hemophilia A patients.1,2

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.1,2,3

Esperoct® is a recombinant Factor VIII treatment.

Esperoct® is made without human blood, plasma, or proteins. Recombinant factor VIII products are a recommended treatment of choice for patients with hemophilia A.4

Esperoct® was shown to provide effective prophylaxis.5

Starting patients on Esperoct®.

Novo Nordisk provides resources to help your patient get started on Esperoct®.

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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. Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: First-inhuman trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013;11(4):670-678.
  2. Esperoct® Summary of Product Characteristics, Novo Nordisk, 2019.
  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 other bleeding disorders, #253. New York, NY: National Hemophilia Foundation; 2018.
  5. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.