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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

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.

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.

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.