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ACHIEVE HIGH TROUGH LEVELS IN HEMOPHILIA A

The pharmacokinetics (PK) of Esperoct® were evaluated in previously-treated patients with severe hemophilia A. Esperoct® achieved high factor levels in adolescents, adults, and children.1,a

aFor children aged 6-11 years, trough level is 2%.

INCREASED FACTOR LEVELS ACROSS AGE GROUPS

In patients aged 12 to 70 years

In an open-label study, Esperoct® achieved factor levels ≥3% for the entire dosing level and ≥5% for 90% of the time.1

Esperoct® factor levels
Esperoct® factor levels
Esperoct® factor levels
Esperoct® factor levels
Esperoct® adult exercising outside

In patients aged 0 to <12 years

PK modeling data showed that Esperoct® provides factor levels >2% for the entire dosing interval for children aged 6-11 years and ≥5% for 72% of the dosing interval.1,d

Aged 6-11 years

Esperoct® factor levels

Aged 6-11 years

Esperoct® factor levels
Esperoct® child running outside

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. 175 PTPs received routine prophylaxis (50 IU/kg Q4D). Mean trough levels for adolescents (12-<18 years) were 2.7 IU/dL.1,2

cIn 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. During the main phase, 68 children received prophylaxis at an average dose of approximately 65 IU/kg twice weekly for 26 weeks.3

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

eSteady-state FVIII activity profiles were estimated in 22 children using a one-compartment model with first-order elimination, including PK parameters of clearance and volume of distribution.1

Esperoct® stays in the body longer through PEGylation technology.1

Simplified dosing.

Esperoct® multiple vial sizes

Fixed dosing for all patients means no calculating desired FIX activity levels.1

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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

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

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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. 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.