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| 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. |
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| See how Esperoct® can check the boxes for your hemophilia A patients. |
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Bleed control |
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| Esperoct® is effective in reducing frequency of bleeds in adults and adolescents (median ABR):1,2,a |
| Pivotal trial main phase: |
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1.2 overall bleeds per year |
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0.9 joint bleeds per year |
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0 spontaneous bleeds and traumatic bleeds |
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0.8 overall bleeds per year3,b (Updated!) |
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Longer half-life |
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| Esperoct® provides longer half-life: |
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Trough levels ≥3% for the entire dosing intervald |
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Based on PK modeling, ≥5% for 90% of the dosing intervale |
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Simple dosing |
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| Esperoct® is an EHL rFVIII that keeps dosing simple for adults and adolescents:1 |
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50 IU/kg every 4 days—no dose adjustment neededf |
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Up to 50% fewer infusionse per year compared to SHL |
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| ABR=annualized bleed rate; PTP=previously treated patient. |
| aIn a phase 3, open-label study, safety, efficacy, and pharmacokinetics (PK) of Esperoct® were evaluated in 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. Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL.1,2 |
| bMedian annualized bleeding rate 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.3 |
| cCompared to FVIII standard half-life products. |
| 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 |
| e50% fewer if previously dosed every other day; 40% fewer if previously dosed 3x/week. |
| fRegimen can be individually tailored to less or more frequent dosing based on bleeding episodes.1 |
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| Scroll to see why Esperoct® may interest your standard half-life (SHL) hemophilia A patients. |
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| Selected Important Safety Information |
| Contraindications |
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Do not use in patients who have known hypersensitivity to Esperoct® or its
components, including hamster proteins
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Warnings and Precautions
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Hypersensitivity reactions, including anaphylaxis, may occur. Should
hypersensitivity reactions occur, discontinue Esperoct® and administer appropriate
treatment
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Please
click here
or scroll below for additional Important Safety Information.
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| Highest temperature stability. Unprecedented half-life. |
| Esperoct® can be stored up to 104°F for up to 3 months—the highest storage temperature of any extended half-life (EHL) rFVIII product.1 In adults, it also achieved an unprecedented 22-hour half-life compared to other EHL products.1,g,h |
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| gIn 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.1,2 |
| hMean half-life in adults, compared with other EHL FVIII products; the mean half-life in adults is 19.7 hours for Eloctate®, 14.7 for Adynovate®, and 17.9-18.6 for Jivi®.4-6 |
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| Support for your patients making a switch. |
| Our product assistance programs and tools are designed to help your patients interested in Esperoct®. Those who qualify may also order a free trial prescription to see if Esperoct® is right for their life with hemophilia A.i |
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| iPatients 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, 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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| iPatients 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, 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 |
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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
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Esperoct® is not indicated for the treatment of von Willebrand
disease
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Important Safety Information (cont’d)
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| Warnings and Precautions |
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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
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| Adverse Reactions |
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The most frequently reported adverse reactions in clinical trials (≥1%) were
rash, redness, itching (pruritus), and injection site reactions
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| Please click here for Prescribing Information. |
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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. |
| 3. |
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. |
| 4. |
Eloctate® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020. |
| 5. |
Adynovate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2021. |
| 6. |
Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018. |
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