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EXTEND HALF-LIFE BEYOND THE STANDARD

EXTEND HALF-LIFE BEYOND THE STANDARD

In open-label clinical trials, Esperoct® achieved a longer half-life across age groups when compared to standard half-life (SHL) Factor VIII products.1,a

LONGER HALF-LIFE COMPARED TO SHL FVIII PRODUCTS

In patients ≥18 years of age

In a phase 1 study with adult patients, Esperoct® achieved a 60% longer half-life compared to SHL FVIII products.1,a

Esperoct® half-life chart
Esperoct® half-life chart

aA phase 1, open-label study evaluated the safety and pharmacokinetic properties of Esperoct® in 26 PTPs. Patients received a single dose of 25, 50, or 75 IU/kg of their previous SHL product (pdFVIII or rFVIII), followed by the same dose of Esperoct®. To allow for comparison, all results were adjusted to a 50 IU/kg dose of each product.1

ESPEROCT® ACHIEVED AN UNPRECEDENTED HALF-LIFE

Compared to other extended half-life (EHL) products, Esperoct® achieved an unprecedented 22-hour half-life in adults.2,b,c

Esperoct® half-life in adults
Esperoct® half-life in adults

bIn 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.2,3

cMean half-life in adults and adolescents, 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

In patients <12 years of age

In an open-label study with pediatric previously treated patients, Esperoct® achieved an 85% longer half-life compared to SHL FVIII products.7,d

Esperoct® half-life in children
Esperoct® half-life in children
Esperoct® toy castle

dIn a phase 3 study of children (aged <12 years) a single-dose PK comparison was performed in 27 children between previous SHL products and Esperoct® at the same administered dose prior to the start of routine prophylaxis. Half-life comparison is based upon the estimated half-life derived from a population based model. During the main phase, 68 children received prophylaxis at an average dose of approximately 65 IU/kg twice weekly for 26 weeks.7

KEEP THEM COVERED LONGER

In a phase 3 study of children (aged <12 years), Esperoct® achieved a 14.3-hour mean half-life.1,8,d,e

Esperoct® half-life in children
Esperoct® half-life in children

eGeometric mean terminal half-life in 23 children. The subjects were 12 children aged 0-5 years and 10 children aged 6-11 years. Estimated geometric terminal mean half-life was 14.7 hours in the younger cohort and 13.8 hours in the older cohort.7,8

Esperoct® extends half-life through PEGylation.2

Trial prescription program.

Esperoct® vial

Qualifying patients can receive a trial prescription for Esperoct®.

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

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. 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.
  2. Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
  3. 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.
  4. Eloctate® [package insert]. Cambridge, MA: Biogen Idec Inc.; 2017.
  5. Adynovate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
  6. Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
  7. 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.
  8. Data on file. Novo Nordisk Inc; Plainsboro, NJ.