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Important Safety Information | | | Prescribing Information
Esperoct® is indicated for on-demand treatment and control of bleeding episodes, perioperative bleed management, and routine prophylaxis in adults and children with hemophilia A.
Put your patients on a path to treatment success they can trust.
Explore Trial Results
Esperoct® was studied in the largest and longest extended half-life clinical trial program for hemophilia A1
The multi-year clinical trial—known as pathfinder™—demonstrated that extended half-life Esperoct® could help patients of all ages maintain high factor levels and longer protection against bleeds.1-4,a,b
Put your patients on a path to treatment success they can trust.
Explore Trial Results
Esperoct® was studied in the largest and longest hemophilia A trial1
The multi-year clinical trial—known as pathfinder™—demonstrated that extended half-life Esperoct® could help patients of all ages maintain high factor levels and longer protection against bleeds.1-3,a-c
Scroll for a closer look at the pathfinder™ study.
a A phase 1, open-label study evaluated the safety and pharmacokinetic properties of Esperoct® in 26 PTPs. Patients received a single dose of 25, 50, or 75 IU/kg of their previous SHL product (pdFVIII or rFVIII), followed by the same dose of Esperoct®. To allow for comparison, all results were adjusted to a 50 IU/kg dose of each product.4
b Esperoct® achieved a low median annual bleed rate in adolescents, adults, and children. In a phase 3, open-label study, PTPs aged ≥12 years with severe hemophilia A were studied. 175 received routine prophylaxis (50 IU/kg every 4 days) and 12 adults elected to be treated on demand during the main phase. Esperoct® achieved factor levels ≥3% for the entire dosing interval (50 IU/kg Q4D) in adolescents and adults ≥12 years. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL. In another study, 68 PTPs (34 aged 0-5 and 34 aged 6-11) received an average dose of approximately 65 IU/kg twice weekly for 26 weeks. Esperoct® achieved factor levels ≥2% for the entire dosing interval for children aged 6 to 11 years.2,3
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
Please click here or scroll below for additional Important Safety Information.
Pathfinder™ clinical trial program
The pathfinder™ clinical trial program was comprised of >80,000 exposure days, in 270 previously treated patients, across 5 prospective, multi-center clinical trials.1
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Pathfinder™ results
There were no thrombotic events, neutralizing anti-PEG antibodies, or hypersensitivity to PEG in the pathfinder™ studies.1,3,c
Discover how Esperoct® works>
• | The observed inhibitor development was consistent with the rate reported in epidemiologic studies (0.15 per 100 patient years)5
• | One PTP with an intron 22 inversion developed a FVIII inhibitor1,3,d
A trusted partner
Esperoct® was developed by Novo Nordisk—a trusted partner of the bleeding disorder community for decades.
Explore high factor levels
Pathfinder™ clinical trial program
The pathfinder™ clinical trial program was comprised of >80,000 exposure days, in 270 previously treated patients, across 5 prospective, multi-center clinical trials.1
Review efficacy>
Pathfinder™ results
There were no thrombotic events, neutralizing anti-PEG antibodies, or hypersensitivity to PEG in the pathfinder™ studies.1,3,c
Discover how Esperoct® works>
• | The observed inhibitor development was consistent with the rate reported in epidemiologic studies (0.15 per 100 patient years)5
• | One PTP with an intron 22 inversion developed a FVIII inhibitor1,3,d
A trusted partner
Esperoct® was developed by Novo Nordisk—a trusted partner of the bleeding disorder community for decades.
Explore high factor levels
c Anti-PEG antibodies of no clinical consequence were detected in 45 subjects, 32 of whom had preexisting anti-PEG antibodies.1
d An 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
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 (cont’d)
Warnings and Precautions
| • | 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.
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References:
1. | Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
2. | Meunier S, Alamelu J, Ehrenforth S et al. Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in pediatric patients with severe haemophilia A. Thromb Haemost. 2017;117:1705-1713.
3. | 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.
4. | Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: First-inhuman trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. Thromb Haemost. 2013;11(4):670-678.
5. | Fischer K, Lassila R, Peyvandi F, et al. Inhibitor development in haemophilia according to concentrate. Thromb Haemost. 2015;114(4):670-675.
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Esperoct® is a registered trademark of Novo Nordisk Health Care AG. Novo Nordisk is a registered trademark of Novo Nordisk A/S. © 2020 Novo Nordisk All rights reserved. US20ESP00054 December 2020 |