Rare Bleeding Disorders
Other Therapy Areas
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
    Other Therapy Areas
    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

Bleed treatment when they need it

Prepare your adult and adolescent hemophilia A patients for the unexpected with effective control of bleeding episodes.

Esperoct® adult exercising outside

Bleed control they can count on

In a Phase 3 pivotal trial, Esperoct® was shown to be effective in controlling 97% of bleeds with 1-2 infusions.1

See study design
97%

of

532

bleeds controlled
with 1-2 infusions1


Fixed dosing for adults and adolescents

Treating bleeds with Esperoct® means there’s no need to calculate desired FIX activity levels.2

Minor/moderate bleeds

40 IU/kg

Major bleeds

50 IU/kg

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

See dosing for adults and adolescents

Study design

Giangrande et al (2017 and 2020)
pathfinder 2 phase 3 clinical trial: main phase and extension

Patients: Previously treated males aged 12–66 years with severe congenital hemophilia A (FVIII activity <1%) and at least 150 exposure days to any FVIII products.3

Study design: Multinational, open-label, non-randomized trial evaluating safety, pharmacokinetics, and clinical efficacy of Esperoct® when used for prophylaxis and treatment of bleeds. During the main phase, 175 patients received routine prophylaxis (50 IU/kg every 4 days), and 12 adults elected to be treated on-demand. A subset of patients (n=150) continued on in extension phase part 1; 139 continued into the non-randomized extension part 2, with 113 completing the trial.1,3

Co-primary endpoints: Incidence of FVIII inhibitors ≥0.6 BU (Bethesda units) and ABR (annualized bleeding rate) for patients on a prophylaxis regimen.1

Efficacy in surgery

Esperoct® was shown to provide effective perioperative bleed control.

See the data

Trial prescription program

Esperoct® vial

Qualifying patients can receive a trial prescription for Esperoct®.

To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.

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. 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(2):252-261. 
  2. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019. 
  3. Giangrande P, Karim F, Nemes L, et al. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: final results from pathfinder2. J Thromb Haemost. 2020;18(1):5-14.
Rare Bleeding Disorders
Other Therapy Areas
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® and NovoCare® are registered trademarks 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    
© 2022 Novo Nordisk All rights reserved. US22ESP00061 November 2022

Quick links

Trial prescription programs

Patient access and affordability options

MASAC treatment guidelines

Patient educational materials