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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.

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.

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

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

ESPEROCT® PROVIDES YOUR ADULT AND ADOLESCENT PROPHYLAXIS PATIENTS:

ESPEROCT® PROVIDES YOUR ADULT AND ADOLESCENT PROPHYLAXIS PATIENTS:

Low Median ABR

Long-term trial results confirm effective
prophylaxis in patients ≥12 yearsb
 

across all bleeds3,c

One Simple Dose

Recommended dose for routine prophylaxis

with no dose adjustment needed and
related PK testing required1,4,d

One Simple Dose

Recommended dose for routine prophylaxis

with no dose adjustment needed and
related PK testing required1,4,d

High Trough Levels

In a phase 3, open-label study of PTPs ≥12 years

ABR=annualized bleed rate; PK=pharmacokinetic; PTP=previously treated patient.

Extension trial design from pathfinder2:

bIn a phase 3, open-label study, safety, PK, 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.3,4

cMedian 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

dRegimen can be individually tailored to less or more frequent dosing based on bleeding episodes.1

eIn 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 factor levels for adolescents (12-<18 years) were 2.7 IU/dL.1,4

fSteady-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

High Trough Levels

In a phase 3, open-label study of PTPs ≥12 years

ABR=annualized bleed rate; PK=pharmacokinetic; PTP=previously treated patient.

Extension trial design from pathfinder2:

bIn a phase 3, open-label study, safety, PK, 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.3,4

cMedian 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

dRegimen can be individually tailored to less or more frequent dosing based on bleeding episodes.1

eIn 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 factor levels for adolescents (12-<18 years) were 2.7 IU/dL.1,4

fSteady-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

PEGylation technology.

Esperoct® extends half-life through PEGylation.

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.1,5-7

PEGylation technology.

Esperoct® extends half-life through PEGylation.

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.1,5-7

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 prescriptiong and product support programs.

Esperoct® package

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 prescriptiong and product support programs.

gPatients 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.

Register to get the latest updates about Esperoct®

Register to get the latest updates about Esperoct®

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

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 Prescribing Information

References:

  1. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019. 
  2. 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. 
  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. 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.
  5. Eloctate® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020. 
  6. Adynovate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018. 
  7. Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.