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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°C 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 If the product has been stored above room temperature (30°C–40°C), then the expiry date is no longer valid and the product should be used within 3 months1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°C–8°C) for up to 30 months, at room temperature (≤30°C) for up to 12 months and above room temperature (30°C–40°C) for up to 3 months1
†After reconstitution, Esperoct® can be stored in the refrigerator (2°C–8°C) for up to 24 hours, ≤30°C for up to 4 hours and between 30°C–40°C for up to 1 hour. The reconstituted solution should be stored in the vial1
ABR, annualised bleeding rate; BIW, twice weekly;
Q4D, every 4 days
*pathfinder2 included previously treated patients ≥12 years with severe haemophilia A (N=186) followed for 6.3 years.4 End of trial data for pathfinder2 are shown4
**Mean change in ABR in patients (N=71) transitioning from pathfinder2 to pathfinder813
†pathfinder8 included previously treated patients from pathfinder2 of all ages with severe haemophilia A (N=160) and followed for a further 2.1 years.13 A subanalysis of pathfinder8 data are shown. Some of the 64% of patients with 0 bleeds in pathfinder2, and who progressed to pathfinder8, may not have been included in the patients reported to have had 0 bleeds in pathfinder813
Esperoct® Summary of Product Characteristics, 2024, Oct.
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