Skip to main content

EFFICACY IN SURGICAL PROCEDURES

EFFICACY IN SURGICAL PROCEDURES

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

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

EFFICACY IN MAJOR SURGERIES

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

Esperoct® surgical efficacy rate
Esperoct® surgical efficacy rate

aA phase 3, open-label, nonrandomized trial to assess the hemostatic efficacy of Esperoct® during major surgery in 33 patients 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). 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

SIMPLE PERIOPERATIVE DOSING.1

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

Esperoct® dosing for all surgeries
Esperoct® dosing for all surgeries

bPerioperative dosing recommendation for pediatric patients is 65 IU/kg.1

cFor 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

Questions about Esperoct®? We’re here to help.

Enter your zip code to find a Novo Nordisk Representative.

Support for your patients.

Esperoct® patient brochure

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

Register to get the latest updates about Esperoct®

Register to get the latest updates about Esperoct®

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. 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.