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Keep patients with hemophilia A protected from bleeds
Are they ready for a switch to an extended half-life rFVIII? Phase 3 pivotal trial results demonstrated the efficacy of Esperoct®, with a low median annual bleed rate for adolescents, adults, and children.1
Keep patients with hemophilia A protected from bleeds
Are they ready for a switch to an extended half-life rFVIII? Phase 3 pivotal trial results demonstrated the efficacy of Esperoct®, with a low median annual bleed rate for adolescents, adults, and children.1
In patients aged 12 to 70 years
Long-term trial results confirm effective prophylaxis in patients (aged 12 to 70 years) for up to 6.6 years.2
A lower overall median ABR in adult and adolescent patients compared with the main phase was achieved2
Overall bleeds per year
N = 177
Pivotal trial main phase data
Esperoct® provided effective prophylaxis with a low median ABR in all patients (aged 12 to 70 years).1
overall bleeds per year
spontaneous bleeds
traumatic bleeds
joint bleeds
ABR=annualized bleed rate.
In patients aged 0 to <12 years
Long-term trial results confirm effective prophylaxis in children (aged 0 to <12 years) for up to 5.4 years.4
A lower overall median ABR in pediatric patients compared with the main phase was achieved4
100% resolution of target joints.4
Overall bleeds per year
N = 68
Pivotal trial main phase data
Esperoct® achieved a low median ABR in children (aged 0 to <12 years).1
all bleeds
spontaneous bleeds
traumatic bleeds
joint bleeds
ABR=annualized bleed rate.
pathfinder™ was the longest and largest extended half-life clinical trial program, evaluating the efficacy and safety of Esperoct® in over 270 patients with hemophilia A worldwide.1
Trial prescription program
Esperoct® may be right for your hemophilia A patients who are interested in switching from their current standard or extended half-life FVIII product. Qualifying patients can now receive a trial prescription.a
To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoCare® Specialist.
Study designs
pathfinder 2 phase 3 clinical trial: main phase (Giangrande, et al. 2017) and extension phases (Giangrande, et al. 2020)
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. After the main phase, a subset of patients continued on in extension phase part 1. After 24 weeks, patients from extension phase part 1 continued into the non-randomized extension part 2 until the end of trial.2,3
Median annualized bleeding rate of 0.8 shown is from the main and extension phases of the pivotal clinical trial of previously treated people aged ≥12 years with severe hemophilia A who received Esperoct® 50 IU/kg every 4 days, for up to 6.6 years.2
pathfinder 5 phase 3 clinical trial: main phase (Meunier, et al)
Data shown are from a study of 68 previously treated children (34 aged 0-5 and 34 aged 6-11) who received an average dose of approximately 65 IU/kg twice weekly for 26 weeks. Median annualized bleeding rates are shown.5
pathfinder 5 phase 3 trial: extension phase (Trakymiene, et al)
In a phase 3 multinational, open-label, single-arm, non-randomized, non-controlled trial of 68 previously treated male patients aged <12 years old with severe congenital hemophilia A, comprising of a main phase and an extension phase.4
A target joint was defined as a single joint with ≥3 bleeding episodes in 6 consecutive months. All baseline target joints reached the per-protocol definition of target joint resolution in slightly over 2 years of treatment with Esperoct®. Per protocol, a target joint was no longer considered a target joint if there were no bleeding episodes for 12 consecutive months. Twelve patients with 16 documented target joints at the baseline participated in main and extension phase of pathfinder 5 clinical trial.4
Median annualized bleeding rate shown is from the main and extension phases of previously treated children with severe hemophilia A, who took Esperoct® 60 IU/kg (50-75 IU/kg) twice weekly for a median of 5 years.4,5
Count on the proven safety profile of Esperoct®.
PEGylation technology
Esperoct® extends half-life through PEGylation.1
aPatients who have been prescribed a Novo Nordisk hemophilia and rare bleeding disorder product for an FDA-approved indication, and who have commercial insurance, may be eligible to receive a limited supply of free product. Patients who participate in any government, state, or federally funded medical or prescription benefit program, including Medicare, Medicaid, Medigap, VA, DOD, and TRICARE, including patients who participate in a managed Medicaid program or have Medicaid as secondary insurance, are not eligible to receive product support. Product is provided at no cost to the patient or the HCP, is not contingent on any product purchase, and the patient and HCP must not: (1) bill any third party for the free product, or (2) resell the free product.
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:
- Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
- 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.
- 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.
- Trakymiene SŠ, Economou M, Kenet G, et al. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: Final results from pathfinder5. J Thromb Haemost. 2020;18(1):15-25.
- Meunier S, Alamelu J, Ehrenforth S, et al. Safety and efficacy of a glycoPEGylated rFVIII (turoctocog alpha pegol, N8-GP) in paediatric patients with severe haemophilia A. Thromb Haemost. 2017;117:1705-1713.