Rare Bleeding Disorders
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
Medical Information | Non-US Health Care Professionals
Account Settings
Communication Preferences
Sign Out
Sign In | Create Account
  • Rare Bleeding Disorders Home
    • Products
      Our Treatments How to Order Trial Prescriptions Recombinant Manufacturing
    • Professional Resources
      Product Resources Library Contact Your Representative
    • Disease Education
      Clinical Education Library Congenital Hemophilia with Inhibitors Acquired Hemophilia Glanzmann's Thrombasthenia Interactive Joint Bleed Model
    • Treatment Guidelines
      MASAC Guidelines WFH Guidelines
    • Additional Resources
      Organizations & Conferences
    • Product Education
      Product Education Materials
    • Disease Education
      Disease Education Resources
    • Access & Affordability
      Prescription Savings & Insurance Support
  • Sign In
    Create Account
    • Account Settings
    • Communication Preferences
    • Sign Out
    Medical Information
    Non-US Health Care Professionals
Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo
Important Safety Information | Patient Site
Prescribing Information
    • Pharmacology
    • Mechanism of Action
    • Prophylaxis
    • On Demand
    • Perioperative
    • Safety Profile
    • Adults & Adolescents
    • Children
    • Reconstitution & Administration
  • Costs & Coverage
    • Patient Education
    • Education for You
    • How to Order
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

Efficacy in surgical procedures

In a phase 3 study, Esperoct® was shown to provide effective perioperative bleed control.1

MixPro® syringe

Efficacy in major surgeries

The hemostatic efficacy of Esperoct® was assessed in 33 adolescent and adult patients with hemophilia A who underwent 45 major surgeries.1

See study design
Esperoct® surgical efficacy rate

Simple perioperative dosing.1

No need to calculate desired FIX activity levels to determine the appropriate dose.

Pre-operative for all surgeriesa,b  

50 IU/kg dosing for all surgeries

aPerioperative dosing recommendation for pediatric patients is 65 IU/kg.1  
bFor 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 and adolescents

Have questions about efficacy or looking for patient resources?

Support for your patients.  

Novo Nordisk provides resources to help your patients start on Esperoct®.

See how we can help

Study design

pathfinder 3 phase 3 clinical trial (Hampton, et al):

A phase 3, open-label, nonrandomized trial to assess the hemostatic efficacy of Esperoct® during major surgery in 33 previously treated adolescents and adults with hemophilia A who underwent 45 major surgeries, 41 of which were orthopedic (15 joint replacements, 9 arthroscopic orthopedic interventions, and 17 classified as “other” orthopedic interventions) based on interim data. The success rate in bleed control during surgery was evaluated on a 4-point scale of excellent, good, moderate, or poor. Treatment success was defined as excellent or good bleed control.1,2  

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. Hampton K, Chowdary P, Dunkley S, et al. First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A. Haemophilia. 2017;23(5):689-696.
Rare Bleeding Disorders
Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
  • Rare Bleeding Disorders Home
  • Product Information
    Products
    • Our Treatments
      How to Order
      Trial Prescriptions
      Recombinant Manufacturing
    Professional Resources
    • Product Resources Library
      Contact Your Representative
  • Professional Education
    Disease Education
    • Clinical Education Library
      Congenital Hemophilia with Inhibitors
      Acquired Hemophilia
      Glanzmann's Thrombasthenia
      Interactive Joint Bleed Model
    Treatment Guidelines
    • MASAC Guidelines
      WFH Guidelines
    Additional Resources
    • Organizations & Conferences
  • Patient Support
    Product Education
    • Product Education Materials
    Disease Education
    • Disease Education Resources
    Access & Affordability
    • Prescription Savings & Insurance Support

Esperoct® is a registered trademark and novoMEDLINK™ is a trademark of Novo Nordisk A/S.
Novo Nordisk is a registered trademark of Novo Nordisk A/S.
All other trademarks, registered or unregistered, are the property of their respective owners.
Non-US Health Care Professionals, please go to www.novonordiskpro.com.

Legal Notice | Privacy Policy | Cookie Policy | Contact Us |
novonordisk-us.com    
© 2021 Novo Nordisk All rights reserved.  US21ESP00013 October 2021

Quick links

Trial prescription programs

Patient access and affordability options

MASAC treatment guidelines

Patient educational materials