An rFVIII designed for portability
For patients with hemophilia A, disease management often depends on choosing a treatment that fits into their daily lives.
rFVIII SHL and EHL comparison guidea,b
SHL=standard half-life; EHL=extended half-life.
The above table is not intended to compare the safety or efficacy of any of the products.
aDoes not include the EHL Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei].
bData current as of March 4, 2022.
Novoeight® is the ONLY SHL rFVIII with stability up to 104˚F for up to 3 months.1-11,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.12,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.12
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.12,13
Selected 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
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
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.
Selected 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
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 Esperoct® Prescribing Information.
References
- Novoeight [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2020.
- Adynovate® [package insert]. Westlake Village, CA: Baxalta US Inc., 2021.
- Advate® [package insert]. Westlake Village, CA: Baxter Healthcare Corporation; 2018.
- Afstyla® [package insert]. Kankakee, IL: CSL Behring LLC; 2021.
- Eloctate™ [package insert]. Cambridge, MA: Biogen Idec Inc.; 2020.
- Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
- Kogenate® [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2019.
- Kovaltry® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2021.
- Nuwiq® [package insert]. Hoboken, NJ: Octapharma USA, Inc.; 2020.
- Recombinate® [package insert]. Westlake Village, CA: Baxalta US Inc.; 2018.
- Xyntha® [package insert]. Philadelphia, PA: Wyeth Pharmaceuticals Inc.; 2020.
- Esperoct [package insert]. Plainsboro, NJ: Novo Nordisk Inc; 2019.
- 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.