![Esperoct® [antihemophilic factor (recombinant), glycopegylated-exei] logo](/content/dam/novonordisk/novomedlink/logos/bleeding-disorders/esperoct.svg)
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.
aPrior to reconstitution, Esperoct® can be stored from 36 °F to 46 °F for up to 30 months, at room temperature up to 86 °F for up to 12 months, or up to 104 °F for up to 3 months.1 See Prescribing Information for complete product storage information.
Patients with hemophilia A said storage flexibility is the second strongest driver when choosing a product7,b
In a clinical study, the strongest drivers of product choice were origin of FVIII (plasma-derived vs recombinant), storage flexibility (temperature), reconstitution device7,b
bStudy of 200 patients diagnosed with moderate or severe hemophilia A to gain insights on usage of factor VIII products and to assess the impact and perceived importance of product storage. Data were collected via 30-minute, face-to-face interview and via a web-based survey. A questionnaire evaluated the effect of 6 features associated with factor VIII products on the choice of the product.7
Do you treat patients who are looking for flexibility that includes . . .
Ryan is 41 years old and has severe hemophilia A. He lives in a warm climate where the average monthly temperature is 95° F.
Actor portrayal. This is a hypothetical patient story.
Offer your patients like Ryan the broadest temperature stability1-6
Before reconstitution:
After reconstitution: use within 4 hours when stored at up to 86 °F or within 24 hours when stored in the refrigerator.1
See Prescribing Information for complete product storage information. Store reconstituted product in vial.
Current treatment experience
- SHL FVIII therapy 3x/week and an ABR of 5
- Has not expressed a strong interest in changing therapies
Daily life
- Active in local advocacy group
- Concerned about the long-term impact of bleeds
- Lives in an area prone to power outages and prefers to take his factor with him
ABR=annualized bleeding rate; FVIII=Factor VIII
Jackson is 14 years old and has moderate hemophilia A. He’s motivated to adhere to treatment so he can stay active.
Actor portrayal. This is a hypothetical patient story.
Offer your patients like Jackson individualized prophylaxis dosing frequency with 1 proven starting dosec
Routine prophylaxis: 50 IU/kg every 4 days for adults and adolescents ≥12 years of age1
- No dose adjustment needed or related PK testing is required1,8
- This regimen may be individually adjusted to less or more frequent dosing based on bleeding episodes1
Current treatment experience
- Prophylaxis with FVIII 2x/weekly and an ABR of 2
- Because of a joint bleed, he sometimes wears a brace
Daily life
- Feels his hemophilia holds him back
- Sometimes faces bullying from peers about his hemophilia
- Parents and friends encourage him to be active
ABR=annualized bleeding rate; FVIII=Factor VIII; SHL=standard half-life
cBased on bleeding episodes. See Prescribing Information for complete dosing instructions.
d50% fewer if previously dosed every other day, 40% fewer if previously dosed 3x/week1
Oliver is 6 years old and was diagnosed at birth with moderate hemophilia A.
Actor portrayal. This is a hypothetical patient story.
Offer your pediatric patients like Oliver a flexible factor he can stay with1,9
Long-term trial results confirm effective prophylaxis. A lower overall median ABR in pediatric patients compared with the main phase was achieved.1,9,c,d
Results in previously treated children (aged 0-11 years) up to 5.4 years
Current treatment experience
- Has switched to EHL FVIII therapies twice due to breakthrough bleeds
- ABR of 3
Daily life
- Spends time at his grandparents’ but finds it hard to sit still
- His parents are concerned about the need to switch FVIII therapy
- Oliver’s mother is active with a caregiver group and at a local HTC
ABR=annualized bleeding rate; EHL=extended half-life; FVIII=Factor VIII; HTC=hemophilia treatment center; PK=pharmacokinetic; SHL=standard half-life
cIn a phase 3, multinational, open-label, single-arm, nonrandomized, noncontrolled trial of 68 previously treated male patients aged <12 years with severe congenital hemophilia A, comprising main phase and and extension phase.1,9
dMedian ABR shown is from the main and extension phases of previously treated children with severe hemophilia A who took Esperoct® 60 IU/kg (50-75 IU/kg) twice weekly for a median of 4.9 years.9
e43% fewer if previously dosed every other day, 33% fewer if previously dosed 3x/week1
Erica is a 36-year-old event planner who has had symptoms since childhood but wasn’t diagnosed with mild hemophilia until she was 33.
Actor portrayal. This is a hypothetical patient story.
Offer your patients like Erica flexible factor with bleed protection for all age groups1,c
Achieve high trough levels for a broad range of patients
Trough levels stabilized in the range of mild/moderate hemophilia for a majority of the time in adults and adolescents1
Current treatment experience
- Uses hormonal contraception to control heavy menstruation
- Hemorrhaged after delivery of first child
- Has severe bleeding phenotype and joint pain despite mild diagnosis and use of FVIII on demand
Daily life
- Normalized low energy and painful bruising
- Endures symptoms to prioritize her son’s hemophilia treatment
- Travels for work and prefers a treatment she can take along easily
ABR=annualized bleeding rate; FVIII=Factor VIII; PK=pharmacokinetic; SHL=standard half-life
cPrior to reconstitution, Esperoct® can be stored from 36 °F to 46 °F for up to 30 months, at room temperature up to 86 °F for up to 12 months, or up to 104 °F for up to 3 months.1 See Prescribing Information for complete product storage information.
dIn 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) for 76 weeks. Steady-state peak and trough levels were recorded from 143 adults and 23 adolescents. Mean trough levels for adolescents (aged 12 to <18 years) were 2.7 IU/dL.1
eSteady-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
fPost hoc analyses were performed on data from the pathfinder2 trial of patients aged ≥12 years with severe hemophilia A who received prophylaxis Q4D. Exploratory descriptive analyses of the data were used to evaluate long-term annual bleed rates and mean factor VIII trough levels which were assessed over time in 53 patients aged ≥12 years with severe hemophilia who received ≥6 years of prophylaxis, every 4 days. Limitations of the analyses include the lack of baseline joint status data, which is clinically relevant for phenotypic assessment prior to treatment initiation. The absence limits the ability to draw conclusions regarding improvement in joint status over time. Several trough-level data were excluded if it was believed that they were elevated due to dosing to treat a recent bleed.10
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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 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
- Esperoct® [package insert]. Plainsboro, NJ: Novo Nordisk, Inc.
- Adynovate® [package insert]. Lexington, MA: Baxalta US 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.
- Jivi® [package insert]. Whippany, NJ: Bayer HealthCare LLC; 2018.
- Tischer B, Marino R, Napolitano M. Patient preferences in the treatment of hemophilia A: impact of storage conditions on product choice. Patient Prefer Adherence. 2018;12:431-441.
- Giangrande P, Abdul Karim F, Nemes L, et al. Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: final results from pathfinder2. J Thromb Haemost. 2020;18(suppl 10):5-14.
- Saulyte Trakymiené S, Economou M, Kenet G, Landorph A, Shen C, Kearney S. Long-term safety and efficacy of N8-GP in previously treated pediatric patients with hemophilia A: final results from pathfinder5. Thromb Haemost. 2020;18(suppl 10):15-25.
- Tiede A, Hampton K, Jiménez-Yuste V, Young G, Benchikh El Fegoun S, Chowdry P. Post-hoc analysis on the long-term response to fixed-dose prophylaxis with N8-GP in patients with haemophilia A. Haemophilia. 2022;28(1):27-35.
- 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(9):1705-1713.