Effectiveness and portability for patients with hemophilia A
Cesar lives with
hemophilia A.
Novoeight® dosing guidelines
Access a dosing formula and tables to calculate the required dosage for your patients.
Novoeight® at a glance
Novoeight® offers features that allow patients to treat on-the-go, at every stage of life.1 See how these features compare to those of other rFVIII SHL and EHL therapies.
Effective bleed control
Data from one of the largest clinical trial programs of a recombinant FVIII (guardian™1, 2, and 3) showed Novoeight® to be effective in adults, adolescents, and children.1,2,a See study designs
Patient support
Check your patients’ coverage and explore programs that may be able to help them with insurance gaps or financial assistance.
rFVIII=recombinant factor VIII; SHL=standard half-life; EHL=extended half-life.
aThe guardian™ clinical trial program included 238 previously treated patients and more than 130,000 exposure days.2-4
A reliable choice for hospitals
Proven success in surgery
100% hemostatic success rate in major and minor surgeries, per guardian™1 and guardian™35
See study designs
>9 years of clinical trial experience in previously treated patients4
No thromboembolic events occurred during the guardian™1, 2, and 3 trials5,6 See study designs
Quick reconstitution and consistent preparation
4-mL prefilled diluent syringe for all vial sizes1
Would your patients benefit from an rFVIII with extended half-life?
With one proven starting prophylaxis dose,b Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] can deliver high trough levels and a low median ABR for adolescent and adult patients.7,c
Please click here for Esperoct® Prescribing Information and see Important Safety Information at the bottom of the page.
ABR=annualized bleed rate.
b50 IU/kg every 4 days. Regimen can be individually tailored to less or more frequent dosing based on bleeding episodes.7
cIn 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. Median ABR of 1.2.7,8
Study designs
Lentz et al (2013)
guardian™1 phase 3 trial4
Patients: 150 male, previously treated patients aged 12–65 years with severe hemophilia A (FVIII activity ≤1%) and without inhibitors to FVIII (<0.6 BU). Prior to this trial, all patients had at least 150 exposure days to any FVIII product. Exposure day is defined as every day where the patient received at least one dose of FVIII.
Study design: Multicenter, multinational, open-label, and non-controlled. Patients infused Novoeight® prophylactically, either 20–40 IU/kg every second day or 20–50 IU/kg three times weekly. Dose for all patients started at 20 IU/kg and was adjusted as necessary at the investigator’s discretion. For breakthrough bleeds, dosage was based on achieving a plasma FVIII activity level of 0.50 IU/mL, with treatment occurring as soon as bleeds were identified. For the 150 patients, mean exposure was 85 exposure days (based on a range of 11 to 172 exposure days).
Primary endpoint: The incidence rate of FVIII inhibitors, measured by positive results for inhibitors (≥0.6 BU) in two consecutive test samples analyzed at a central laboratory.
Lentz et al (2018)
guardian™2 phase 3b extension trial
Patients: Previously treated pediatric patients (0–11 years), adolescents (12-17 years), and adults (18-65 years) with severe hemophilia A (FVIII activity ≤1%) and without inhibitors. Patients had completed earlier phase 1 pharmacokinetic trials (guardian™1 or guardian™3) and chose to continue taking Novoeight® as prophylaxis (n=207) and/or on-demand treatment (n=19).2,4,9
Study design: Non‐randomized, open‐label, multicenter, multinational, single‐arm, safety and efficacy extension trial. Patients infused Novoeight® prophylactically, with standard dosing (25–50 IU/kg every second day or 20–60 IU/kg three times weekly) or less-frequent dosing (40-60 IU/kg twice weekly or once every third day). The recommended dose level for on-demand treatment was 20-50 IU/kg.9
Primary endpoint: The incidence rate of FVIII inhibitors (≥0.6 BU).9
Secondary endpoint: Frequency of adverse events and serious adverse events.9
Kulkarni et al
guardian™3 phase 3 trial2
Patients: Male, previously treated patients aged 0–11 years (n=63) with severe hemophilia A (FVIII activity ≤1%) and without inhibitors. Prior to this trial, all patients had at least 50 exposure days to any FVIII product.
Study design: Multinational, open-label, and uncontrolled. Patients infused Novoeight® prophylactically, either 25–50 IU/kg every second day or 20–60 IU/kg three times weekly. For breakthrough bleeds, dosage was based on achieving a plasma FVIII activity level of 0.50 IU/mL with treatment occurring as soon as bleeds were identified. For the 63 patients, mean exposure was 60 exposure days (based on a range of 20 to 104 exposure days).
Primary endpoint: The incidence rate of FVIII inhibitors, measured by positive results for inhibitors (≥0.6 BU) in two consecutive test samples analyzed at a central laboratory.
Santagostino et al
Surgery-related efficacy and safety (guardian™ clinical trial program)5
Patients: Male patients participating in guardian™1 (adults and adolescents), guardian™3 (children), or guardian™2 (safety and efficacy extension) trials. Data shown is from guardian™1 and guardian™3 only. All patients had severe hemophilia A (FVIII ≤ 1%) without inhibitors and were previously treated with at least 150 exposure days (adolescents and adults) or at least 50 exposure days (children) to any FVIII product.
Study design: Thirty-three male patients (7 children, 1 adolescent and 25 adults) underwent a total of 15 major and 26 minor surgical procedures. Patients received Novoeight® as bolus injections or continuous infusion, at dosage determined by the investigator, including a loading dose immediately prior to surgery.
Endpoints: The safety and efficacy of Novoeight® as perioperative treatment was assessed as part of the secondary objectives of the guardian™ trial program. Efficacy assessment included hemostatic response, which was evaluated at the end of the surgical procedure. A hemostatic response rated as “excellent” or “good” was considered treatment success.
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
- 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.
References
- Novoeight® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- Kulkarni R, Karim FA, Glamocanin S, et al. Results from a large multinational clinical trial (guardian™3) using prophylactic treatment with turoctocog alfa in paediatric patients with severe haemophilia A: safety, efficacy and pharmacokinetics. Haemophilia. 2013;19(5):698-705.
- Lentz S, Janic D, Ozelo MC, et al. End-of-trial results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Poster presented at: International Society on Thrombosis and Haemostasis 26th Biennial Congress Meeting; July 8-13, 2017; Berlin, Germany.
- Lentz SR, Misgav M, Ozelo M, et al. Results from a large multinational clinical trial (guardian™1) using prophylactic treatment with turoctocog alfa in adolescent and adult patients with severe haemophilia A: safety and efficacy. Haemophilia. 2013;19:691-697.
- Santagostino E, Lentz SR, Misgav M, et al. Safety and efficacy of turoctocog alfa (NovoEight®) during surgery in patients with haemophilia A: results from the multinational guardian™ clinical trials. Haemophilia. 2015;21(1):34-40.
- Lentz SR, Cerqueira M, Janic D, et al. Interim results from a large multinational extension trial (guardian™2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A. Haemophilia. 2016;22(5):e445-e449.
- Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk Inc.
- 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.
- Lentz SR, Janic D, Kavakli K, et al. Long-term safety and efficacy of turoctocog alfa in prophylaxis and treatment of bleeding episodes in severe haemophilia A: Final results from the guardian 2 extension trial. Haemophilia. 2018;24(6):e391-e394.
