TABLE 3.
Proportion of pediatric patients with predicted AUCSS values above or below the specified adult AUC values (pharmacokinetic analysis set)a
| Measurement | Data for i.v. cohort: |
Data for oral cohort: |
|||
|---|---|---|---|---|---|
| 1 to <6 yrs (n = 9) | 6 to <12 yrs (n = 8) | 12 to <18 yrs (n = 9) | 6 to <12 yrs (n = 9) | 12 to <18 yrs (n = 10) | |
| Patients below the target range (60 μg · h/ml)b (%) | 11.4 | 7.2 | 18.0 | 9.3 | 21.6 |
| Patients within target range (60–233 μg · h/ml)c (%) | 85.7 | 86.8 | 80.2 | 87.1 | 76.5 |
a
Pharmacokinetic analysis set included all patients who received ≥1 dose of the study drug and had ≥1 plasma concentration measurement.
b
Delineation of the 25th percentile of AUCSS from the phase 3 SECURE study in adults (30).
c
Upper limit was the minimum AUC from 0 to 24 h (AUC0–24) from a phase 1 safety study in adults using a supratherapeutic dose of isavuconazonium sulfate (1,116 mg) (27). AUCSS, area under the isavuconazole concentration–time curve at steady state (predicted values); i.v., intravenous.