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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

Storage flexibility

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 If the product has been stored above room temperature (30°C–40°C), then the expiry date is no longer valid and the product should be used within 3 months1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

1.

Esperoct® Summary of Product Characteristics, 2024, Feb.

2.

Chowdary P et al. Res Pract Thromb Haemost 2019; 3:542–554.

3.

Giangrande P et al. J Thromb Haemost 2017; 117:252–261.

4.

Giangrande P et al. J Thromb Haemost 2020; 18:5–14

5.

Napolitano M et al. J Blood Med 2021; 12:9–20

6.

Adynovi® Summary of Product Characteristics, 2019.

7.

Elocta® Summary of Product Characteristics, 2021.

8.

Jivi® Summary of Product Characteristics, 2020.

9.

Tiede A et al. J Thromb Haemost 2013; 11:670–678.

10.

Tiede A et al. Haemophilia 2022; 28:27–35.

11.

Lentz S et al. Res Pract Thromb Haemost 2022; 6:1–12.

12.

Eichler et al. Patient Prefer Adher 2023; 17:3001–3014.

13.

Lentz SR, et al. Res Pract Thromb Haemost 2022:6:e12674.