![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo](/content/dam/novonordisk/novomedlink/logos/bleeding-disorders/esperoct.svg)
Esperoct® has been studied in:
- Observed inhibitor development in PTPs is consistent with the rate reported in epidemiologic studies (0.15 per 100 patient years)4
- One PTP with an intron 22 inversion developed a FVIII inhibitor1,3,a
aAn 18-year-old African-American male with an intron 22 inversion developed a low-titer inhibitor after 93 Esperoct® exposure days that subsequently rose to 13.5 Bethesda units, prompting withdrawal from the study. There was no change in efficacy, and the inhibitor eventually went away on its own (without use of ITI).3
Adverse reactions
In clinical trials, the most frequently reported adverse reactions in PTPs with incidence ≥1% were1:
Rash
5.2%
Injection site reactions
2.6%
Redness
1.9%
Itching (pruritus)
1.5%
• Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity
Recombinant manufacturing
Esperoct® is a recombinant factor VIII treatment made without human blood, plasma, or proteins.1
What are the latest recommendations?
The National Hemophilia Foundation’s Medical and Scientific Advisory Council (MASAC) names recombinant factor VIII products as the recommended treatment of choice for patients with hemophilia A.5,b
• Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity
bA possible exception is for newly diagnosed patients, which should be further discussed with the healthcare provider. Please refer to MASAC for full recommendations.
PTPs=previously treated patients
Long-term safety results—pathfinder82
- 160 patients were treated for ~1.9 years
- Most adverse events were mild or moderate and no safety issues observed with laboratory or vital sign parameters
- Longest exposure to Esperoct® was ~8.4 yearsc
cComprising 6.3 years in pathfinder2 and 2.1 years in pathfinder8.2
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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
- Temporary decrease in Factor VIII incremental recovery (IR) has been observed after Esperoct® infusion, within the first 5 exposure days, in previously untreated patients (PUPs) <6 years of age. During the decreased IR period, these subjects may have an increased bleeding tendency. If bleeding is not controlled with the recommended dose of Esperoct® and/or the expected Factor VIII activity levels are not attained and Factor VIII inhibitors are not detected, consider adjusting the dose, dosing frequency, or discontinuing Esperoct®
Adverse Reactions
- The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions. Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity.
Please click here for Esperoct® Prescribing Information.
- Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Lentz SR, Kavalki K, Klamroth R, et al. Turoctocog alpha pegol (NB-GP) in severe hemophilia A: long-term safety and efficacy in previously treated patients of all ages in the pathfinder8 study. Res Pract Thromb Haemost. 2022;6(2):e12674.
- 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(02):252-261.
- Fischer K, Lassila R, Peyvandi F, et al. Inhibitor development in haemophilia according to concentrate. Thromb Haemost. 2015;114(4):670-675.
- National Hemophilia Foundation. MASAC recommendations concerning products licensed for the treatment of hemophilia and other bleeding disorders, #284. New York, NY: National Hemophilia Foundation; 2020.