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KEEP HEMOPHILIA A PATIENTS PROTECTED FROM BLEEDS

KEEP HEMOPHILIA A PATIENTS 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

LOW MEDIAN ANNUAL BLEED RATE ACROSS AGE GROUPS

In patients aged 12 to 70 years

Esperoct® provided effective prophylaxis with a low median ABR in all patients (aged 12 to 70 years).1,a

In patients aged 0 to 12 years

Esperoct® achieved a low median ABR in children (aged 0 to 12 years).1,b

Esperoct® overall annual bleed rate for children
Esperoct® overall annual bleed rate for children
Esperoct® joint, spontaneous, and traumatic bleed rate for children
Esperoct® child running outside

ABR=annualized bleed rate.

aIn 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. Treatment-requiring bleeds were reported by patients through diaries.2

bData 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.3

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

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

Esperoct® vial

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.c

To learn more about our trial prescription program, please call 1-844-668-6732 to speak with a NovoSecure™ Specialist.

cPatients 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.

Count on the proven safety profile of Esperoct®.

PEGylation technology.

Esperoct® extends half-life through PEGylation.

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. 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. 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.