For on-demand bleed control, surgery and routine prophylaxis in adults and children with hemophilia A. Not for von Willebrand disease.
An rFVIII designed for portability
For patients with hemophilia A, disease management often depends on choosing a treatment that fits into their daily lives.
Novoeight® and Esperoct® are the ONLY SHL rFVIII with stability up to 104˚F for up to 3 months.1-12,c
cCompared with other selected rFVIII SHL and EHL products.
Looking for an rFVIII with extended half-life?
With one proven starting prophylactic dose,d Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] can deliver high trough levels and a low median ABR for adolescent and adult patients.7,e
Please click here for Esperoct® Prescribing Information and see Important Safety Information at the bottom of the page.
ABR=annualized bleed rate.
d50 IU/kg every 4 days. Regimen can be individually tailored to less or more frequent dosing based on bleeding episodes.7
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 trough levels for adults (age ≥18 years) were 3.0 IU/dL and for adolescents (12 to less than 18 years) were 2.7 IU/dL.7,13
Important Safety Information for Novoeight®
Contraindications
- Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins
Warnings and Precautions
- Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment
- Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight® in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors
Adverse Reactions
- The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia.
Please click here for Novoeight® Prescribing Information.
Indications and Usage
Novoeight® (antihemophilic factor, recombinant) is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
- Novoeight® is not indicated for the treatment of von Willebrand disease
Important Safety Information for Esperoct®
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
- Temporary decrease in Factor VIII incremental recovery (IR) has been observed after Esperoct® infusion, within the first 5 exposure days, in previously untreated patients (PUPs) <6 years of age. During the decreased IR period, these subjects may have an increased bleeding tendency. If bleeding is not controlled with the recommended dose of Esperoct® and/or the expected Factor VIII activity levels are not attained and Factor VIII inhibitors are not detected, consider adjusting the dose, dosing frequency, or discontinuing Esperoct®
Adverse Reactions
- The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions. Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity.
Please click here for Esperoct® Prescribing Information.
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 for Novoeight®
Contraindications
- Do not use in patients who have had life-threatening hypersensitivity reactions, including anaphylaxis, to Novoeight® or its components, including hamster proteins
Warnings and Precautions
- Anaphylaxis and severe hypersensitivity reactions are possible. Patients may develop hypersensitivity to hamster proteins, which are present in trace amounts in the product. Should symptoms occur, discontinue Novoeight® and administer appropriate treatment
- Development of activity-neutralizing antibodies (inhibitors) may occur. Previously untreated patients (PUPs) are at greatest risk for inhibitor development with all factor VIII products. Inhibitors have been reported following administration of Novoeight® in PUPs. If expected plasma factor VIII activity levels are not attained, or if bleeding is not controlled with an appropriate dose, perform testing for factor VIII inhibitors
Adverse Reactions
- The most frequently reported adverse reactions (≥1%) were inhibitors in Previously Untreated Patients (PUPs), injection site reactions, and pyrexia.
Please click here for Novoeight® Prescribing Information.
Indications and Usage
Novoeight® (antihemophilic factor, recombinant) is indicated for use in adults and children with hemophilia A for on-demand treatment and control of bleeding episodes, perioperative management, and routine prophylaxis to reduce the frequency of bleeding episodes.
- Novoeight® is not indicated for the treatment of von Willebrand disease
Important Safety Information for Esperoct®
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
- Temporary decrease in Factor VIII incremental recovery (IR) has been observed after Esperoct® infusion, within the first 5 exposure days, in previously untreated patients (PUPs) <6 years of age. During the decreased IR period, these subjects may have an increased bleeding tendency. If bleeding is not controlled with the recommended dose of Esperoct® and/or the expected Factor VIII activity levels are not attained and Factor VIII inhibitors are not detected, consider adjusting the dose, dosing frequency, or discontinuing Esperoct®
Adverse Reactions
- The most frequently reported adverse reactions in clinical trials (≥1%) were rash, redness, itching (pruritus), and injection site reactions. Additional frequently reported adverse reactions (≥1%) in PUPs included Factor VIII inhibition and hypersensitivity.
Please click here for Esperoct® Prescribing Information.
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
References
Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
Advate® [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A. Inc; 2023.
Adynovate® [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A. Inc; 2023.
Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2023.
Altuviiio® [package insert]. Waltham, MA: Bioverativ Therapeutics Inc; 2023.
Eloctate™ [package insert]. Waltham, MA: Bioverativ Therapeutics Inc; 2023.
Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
Kovaltry® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2022.
Nuwiq® [package insert]. Paramus, NJ: Octapharma USA, Inc; 2021.
Recombinate® [package insert]. Lexington, MA: Takeda Pharmaceuticals U.S.A. Inc; 2023.
Xyntha® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2022.
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.