Explore diabetes
Explore obesity
Explore rare bleeding disorders
Explore growth-related disorders
Explore hormone replacement therapy
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

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

97%

of

532

bleeds controlled
with 1-2 infusions1

Dosing that keeps things simple

Simple starting dosing 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 additional dose can be administered every 24 hours for major or life-threatening bleeding.

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

Study design

pathfinder 2 phase 3 clinical trial (main phase, Giangrande, et al. 2017):

In a phase 3, open-label study, safety, pharmacokinetics, and efficacy of Esperoct® were evaluated in PTPs aged ≥12 years with severe hemophilia A; 175 received routine prophylaxis (50 IU/kg every 4 days) and 12 adults elected to be treated on demand during the main phase. Treatment-requiring bleeds were reported by patients through diaries. 12 patients treated on demand reported 532 of 968 bleeds in the main phase.1

Efficacy in surgery

Esperoct® was shown to provide effective perioperative bleed control.

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.