Table 1.
Coagulation factor products required for the treatment of breakthrough bleeds under emicizumab prophylaxis before and after issuing the guidance
| Pre‐guidance | Post‐guidance | |
|---|---|---|
| FVIII | ||
| Number of patients administered more than once | 5 | 3 |
| Number of administrations | 230 | 218 |
| Dose per administration [IU/kg] | 28.9 (12.3–41.6) | 27.8 (16.3–41.6) |
| Number of administrations per bleed | 3 (1–41) | 2 (1–40) |
| Cumulative dose per bleed [IU/kg] | 73.5 (12.3–1184.2) | 65.4 (20.8–1111.1) |
| aPCC | ||
| Number of patients administered more than once | 4 | 2 |
| Number of administrations | 22 | 6 |
| Dose per administrations [U/kg] | 84.0 (72.5–101.4) | 43.5 (38.5–43.5) |
| Number of administrations per bleed | 1 (1–4) | 3 (1–5) |
| Cumulative dose per bleed [U/kg] | 84.0 (72.5–405.8) | 127.9 (38.5–217.4) |
| rFVIIa | ||
| Number of patients administered more than once | 4 | 3 |
| Number of administrations | 54 | 57 |
| Dose per administration [μg/kg] | 252.1 (85.7–252.1) | 87.0 (49.0–97.5) |
| Number of administrations per bleed | 1 (1–4) | 2 (1–54) |
| Cumulative dose per bleed [μg/kg] | 252.1 (85.7–1008.4) | 194.9 (49.0–4695.7) |
Only treatment for bleeding was included. Data are reported as median (min–max).
Abbreviations: aPCC, activated prothrombin complex concentrate; FVIII, factor VIII; rFVIIa, recombinant activated factor VII.