Table 5.
Treatment-related adverse events versus corresponding observed voriconazole exposure parameters in children with high exposuresa
| Subjectb | Adverse event(s)c | AE onset study day | Period | AUC0-12 (μg·h/ml) | Cmax (μg/ml) | Cmin (μg/ml) |
|---|---|---|---|---|---|---|
| 34 (8, F, 45.2) | Hypoxia | 10 | IV | 162 | 14.9 | 10.9 |
| 39 (2, F, 12.8) | None | IV | 145 | 15.4 | 9.39 | |
| 32 (5, M, 15.9) | Increased ALT and AST | 7 | IV | 81.4 | 9.70 | 4.59 |
| 33 (4, M, 14.2) | Increased ALT and ASTd | 11 (day 5 of oral treatment) | Oral | 203 | 18.0 | 12.8 |
| 39 (2, F, 12.8) | None | Oral | 179 | 18.0 | 11.9 | |
| 3 (2, M, 10.9) | None | Oral | 158 | 14.6 | 8.41 | |
| 37 (4, M, 15.5) | None | Oral | 87.8 | 10.1 | 5.20 |
a
Each subject received voriconazole at 7 mg/kg IV q12h followed by 200 mg PO q12h.
b
Data are age (years), sex, and weight (kilograms). All children were classified by CYP2C19 genotype as HEMs.
c
IV, intravenous, ALT, alanine aminotransferase, AST, aspartate aminotransferase.
d
These events resolved on day 10 oral without any alteration of study drug treatment.