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View the data for Esperoct^® (antihemophilic factor [recombinant], glycopegylated-exei).

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.

Imagine your severe hemophilia A patients at mild levels.

Adolescents and adults with severe hemophilia A treated prophylactically with 50 IU/kg of Esperoct^® every 3 to 4 days may be able to achieve factor levels associated with mild hemophilia A approximately 95% of the time based on PK modeling data.^b

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^aThe World Federation of Hemophilia defines the percentage of normal factor activity in blood in mild hemophilia as 5% - 40%; in moderate hemophilia as 1% - 5%; and of severe hemophilia as >1%.
^bBased on PK modeling from PK assessments that were obtained from 8 previously treated patients (PTPs) aged ≥18 years with severe hemophilia A who participated in a Phase 1 open-label study, 23 PTPs aged ≥12 years with severe hemophilia A who participated in a Phase 3 open-label study, and 18 PTPs aged ≥18 years with severe hemophilia A who participated in a Phase 1 double-blind study; all received routine prophylaxis (50 IU/kg every 4 days). All PK assessments were based on a 50 IU/kg dose.¹

Keep scrolling for pharmacokinetic (PK) predictions for children <12.

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

Please click here or scroll below for additional Important Safety Information.

What if your pediatric patients could achieve moderate levels?

Children ages 0-11 years with severe hemophilia A treated prophylactically with ~60 IU/kg of Esperoct^® every 3 to 4
days may be able to achieve factor levels associated
with moderate hemophilia A ~98% of the time.^c

See more PK data

^cBased on PK modeling from PK assessments that were obtained from 24 previously treated children (13 aged 0-5 years and 11 aged 6-11 years) with severe hemophilia A who participated in a Phase 3, open-label study; all received an average dose of approximately 60 IU/kg twice weekly. All PK assessments were based on a 50 IU/kg dose.

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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

Important Safety Information (cont’d)

Warnings and Precautions

•

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

Chowdary P, Carcao M, Holme P, et al. Fixed doses of N8-GP prophylaxis maintain moderate-to-mild Factor VIII levels in the majority of patients with severe hemophilia A. Res Pract Thromb Haemost. 2019;00:1-13.

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