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*In studies of previously treated patients, 12 years and above1
**Prophylaxis: the recommended dose is 50 IU of Esperoct® per kg of body weight every 4 days. Adjustments of doses and administration intervals may be considered based on achieved FVIII levels and individual bleeding tendency1
†3% mean trough levels observed1,3,4
††Total ABR for all bleeds, including spontaneous and traumatic bleeds4
‡Refer to Esperoct® SmPC for full storage conditions1
ABR, annualised bleed rate; EHL, extended half-life; FVIII, factor VIII; rFVIII, recombinant factor VIII
The image shown is a model and not a real patient
EHL, extended half-life; rFVIII, recombinant factor VIII
Only Esperoct® offers storage flexibility between 30° and 40°C for up to 3 months among EHL rFVIII1,5-8
*Once the product has been stored outside of the refrigerator, it must not be returned for storage in the refrigerator. If the product has been stored above room temperature (30°–40°C), then the expiry date is no longer valid and the product should be used within 3 months1
**Before reconstitution, Esperoct® can be stored in the refrigerator (2°–8°C) for up to 30 months, at room temperature (≤30°C) for up to 12 months and above room temperature (30°–40°C) for up to 3 months1
†After reconstitution, Esperoct® can be stored in the refrigerator (2°–8°C) for up to 24 hours, ≤30°C for up to 4 hours and between 30°–40°C for up to 1 hour. The reconstituted solution should be stored in the vial1
Esperoct® 50 IU/kg every 4 days offers effective prophylaxis, but patients with an ABR >1 could benefit from dose and dosing interval individualisation4,11
*Results from a post hoc analysis of patients who completed the entire pathfinder 2 trial are shown. In pathfinder 2, a Phase III trial, 186 previously treated patients ≥12 years of age with severe haemophilia A were treated with Esperoct® for a median of 5.4 years. 177 patients received Esperoct® prophylaxis of 50 IU/kg every 4 days. Bleeding episodes were treated with Esperoct® doses of 20–75 IU/kg4
**Number of patients who were on Esperoct® 50 IU/kg every-4-days prophylaxis was different in each year of the trial4
***Compared with patients who had a lower ABR ≤111
†Total ABR for all bleeds, including spontaneous and traumatic bleeds4
†† A general trend for reduction in bleed frequency over time was observed4,10
††† Demonstrated in 90% of patients who had a mean ABR >1 while dosing Esperoct® 50 IU/kg every 4 days in pathfinder 211
‡71 patients switched from Esperoct® 50 IU/kg every 4 days in pathfinder 2 to 50 IU/kg twice weekly in pathfinder 811
‡‡ Results from pathfinder 8, a Phase III trial of patients recruited from the completed pathfinder 2 trial. Patients received Esperoct® for up to 104 weeks, administered every 7 days, twice weekly or three times weekly. Number of patients who were on Esperoct® 50 IU/kg twice weekly prophylaxis was different in each year of the trial11
§ Out of 71 patients (who switched from Esperoct® 50 IU/kg every 4 days in pathfinder 2 to 50 IU/kg twice weekly in pathfinder 8), 61 remained on 50 IU/kg twice weekly dosing in the second year of pathfinder 811
§§ Of 71 patients, 30 had a mean ABR >111
Did you find what your were looking for?
Esperoct® Summary of Product Characteristics, 2022.
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Giangrande P et al. J Thromb Haemost 2017; 117:252–261.
Giangrande P et al. J Thromb Haemost 2020; 18:5–14
Napolitano M et al. J Blood Med 2021; 12:9–20
Adynovi® Summary of Product Characteristics, 2019.
Elocta® Summary of Product Characteristics, 2021.
Jivi® Summary of Product Characteristics, 2020.
Tiede A et al. J Thromb Haemost 2013; 11:670–678.
Tiede A et al. Haemophilia 2022; 28:27–35.
Lentz S et al. Res Pract Thromb Haemost 2022; 6:1–12.