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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.
Esperoct® offers patients simple dosing,a high factor levels,b,c and a low median ABR.1,b,d That’s why I’m prescribing Esperoct® for my patients.”
—Dr. Tami Singleton
Chief of Pediatric Hematology and Director of the HTC at the Mississippi Center for Advanced Medicine.
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a Recommended dose for routine prophylaxis in adults and adolescents ≥12 years: 50 IU/kg every 4 days. Recommended dose for routine prophylaxis in children <12 years: 65 IU/kg twice weekly. Regimen can be individually tailored to less or more frequent dosing based on bleeding episodes.1
b In a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct® were evaluated in previously treated patients (PTPs) aged ≥12 years with severe hemophilia A. Single-dose PK studies were performed in 42 adults after receiving Esperoct® 50 IU/kg; 175 PTPs received routine prophylaxis (50 IU/kg Q4D) for 76 weeks and 12 adults elected to be treated on demand during the main phase. Treatment-requiring bleeds were reported by patients through diaries.1,2
c In adults and adolescents, factor levels were ≥3% for the entire dosing interval and in PK modeling data, ≥5% for 90% of the time. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL. Steady-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
d In adults and adolescents on prophylaxis, overall median annual bleed rate (ABR) was 1.2 bleeds/year, and median ABR of 0.9 joint bleeds and 0 spontaneous and traumatic bleeds.
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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
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Introducing the Esperoct®
Trial Prescription Program
Qualifying patients can access an initial supply of Esperoct®—at no cost.e Are your patients eligible?
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e Patients 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.
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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
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References:
1. | Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
2. | 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.
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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. US20ESP00091 October 2020 |