![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo](/content/dam/novonordisk/novomedlink/logos/bleeding-disorders/esperoct.svg)
Move beyond the thresholda
Esperoct® is an extended half-life (EHL) rFVIII treatment for your patients with hemophilia A.1
aOf 1% trough levels for standard half-life (SHL) products in adults and adolescents.1,2
Stable trough levels and decreased ABR from long-term prophylaxis
In a post hoc analysis, long-term prophylaxis (≥6 years) showed a stabilization in mean FVIII trough levels and decrease in ABR over time in adults and adolescents taking Esperoct®.3,b
bPost hoc analyses were performed on data from the pathfinder 2 trial of patients aged >12 years with severe hemophilia A. Exploratory descriptive analyses of the data were used to evaluate long-term annual bleed rates and mean factor VIII trough levels which were assessed over time in 61 patients who received ≥6 years of prophylaxis, every 4 days. Limitations of the analyses include the lack of baseline joint status data, which is clinically relevant for phenotypic assessment prior to treatment initiation. The absence limits the ability to draw conclusions regarding improvement in joint status over time. Several trough-level data were excluded if it was believed that they were elevated due to dosing to treat a recent bleed.3
Stable trough levels and decreased ABR from long-term prophylaxis
In a post hoc analysis, long-term prophylaxis (≥6 years) showed a stabilization in mean FVIII trough levels and decrease in ABR over time in adults and adolescents taking Esperoct®.3,b
bPost hoc analyses were performed on data from the pathfinder 2 trial of patients aged >12 years with severe hemophilia A. Exploratory descriptive analyses of the data were used to evaluate long-term annual bleed rates and mean factor VIII trough levels which were assessed over time in 61 patients who received ≥6 years of prophylaxis, every 4 days. Limitations of the analyses include the lack of baseline joint status data, which is clinically relevant for phenotypic assessment prior to treatment initiation. The absence limits the ability to draw conclusions regarding improvement in joint status over time. Several trough-level data were excluded if it was believed that they were elevated due to dosing to treat a recent bleed.3
Esperoct® provides your adult and adolescent prophylaxis patients:
Low Median ABR
Long-term trial results up to 6.6 years confirm effective
prophylaxis in patients ≥12 years
Based on a post hoc analysis, the majority of adults/adolescents who completed the entire trial experienced no annual bleeds after year 1.4,c
cBased on a post hoc analysis of patients who completed the entire pathfinder 2 trial (n=110) who took Esperoct® 50 IU/kg every 4 days for up to 6.6 years. Patients evaluated at year 2 (n=103), year 3 (n=66), year 4 (n=62), year 5 (n=62), year 6 (n=59).4
High Trough Levels
In a phase 3, open-label study of PTPs >12 years
for the entire dosing interval1
for 90% of the dosing interval1,d
mean trough levels maintained (N=61) as seen in 6+ years post hoc analysis3,e
dSteady-state FVIII activity profiles were estimated in 143 patients using a one-compartment model with first-order elimination with PK parameters of clearance and volume of distribution.1
eExploratory descriptive analyses of the data were used to evaluate long-term annual bleed rates and mean factor VIII trough levels which were assessed over time in 61 patients who received ≥6 years of prophylaxis, every 4 days. Limitations of the analyses include the lack of baseline joint status data, which is clinically relevant for phenotypic assessment prior to treatment initiation. The absence limits the ability to draw conclusions regarding improvement in joint status over time. Several trough-level data were excluded if it was believed that they were elevated due to dosing to treat a recent bleed.3
Vial shown contains 1000 IU.
One Proven Starting Dose
for routine prophylaxis (adults and adolescents)
- No dose adjustment needed and related PK testing required1,5
- Regimen can be individualized to less or more frequent dosing based on bleeding episodes1
Patients who take Esperoct® are likely to stay with Esperoct®
Among EHL products, fewer Esperoct® prescriptions were switched to another product.6,f
ABR=annualized bleed rate; PK=pharmacokinetic; PTP=previously treated patient.
fBased on data for Q2 2020-Q2 2021; accounts for net gains and losses of patients switching to and from extended half-life rFVIII available for at least one year.6
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.5
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.4,5
Co-primary endpoints: Incidence of FVIII inhibitors ≥0.6 BU (Bethesda units) and ABR (annualized bleeding rate) for patients on a prophylaxis regimen.4
Getting your patients started on Esperoct®.
Novo Nordisk is here to help your hemophilia A patients who want to make the switch to Esperoct®. Learn about our trial prescriptionh and product support programs.
Ready when they are.
Esperoct® is the only extended half-life rFVIII that can be stored at up to 104˚F for up to 3 months or 86˚F for up to 12 months.1,7-9
hPatients who have been prescribed a Novo Nordisk hemophilia and rare bleeding disorder product for an FDA-approved indication, and who have commercial insurance or who are uninsured, 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 and 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.
- Tiede A, Brand B, Fischer R, et al. Enhancing the pharmacokinetic properties of recombinant factor VIII: first-in-human trial of glycoPEGylated recombinant factor VIII in patients with hemophilia A. J Thromb Haemost. 2013;11(4):670-678.
- Tiede A, Hampton K, Jiménez-Yuste V, Young G, Benchikh El Fegoun S, Chowdry P. Post-hoc analysis on the long-term response to fixed-dose prophylaxis with N8-GP in patients with haemophilia A. Haemophilia. 2021;10.1111/hae.14409.
- 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.
- Data on file. Novo Nordisk Inc; Plainsboro, NJ.
- Eloctate® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020.
- Adynovate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2021.
- Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.