Table 5.
Serum pharmacokinetic parameters of inotuzumab ozogamicin
| Dose (Once/4 weeks) | Treatment Day (n) | Number of cycles | Cmax (ng/mL) (%) | t1/2 (h) (%) | AUC (ng h/mL) (%) | CL (L/h) (%) | Vss (L) (%) |
|---|---|---|---|---|---|---|---|
| 1.3 mg/m2 | 1 (3) | 1 | 463 (8) | NC | NC | NC | NC |
| 29 (3) | 2 | 610 (17) | 29.7 (30) | 24166 (29) | 0.08 (32) | 3.27 (11) | |
| 57 (3) | 3 | 524 (18) | 43.6 (18) | 31642 (21) | 0.06 (22) | 3.79 (12) | |
| 1.8 mg/m2 | 1 (10) | 1 | 657 (41) | 13.0 (30) | 14266 (32) | 0.24 (40) | 4.06 (21) |
| 29 (8) | 2 | 727 (27) | 35.8 (43) | 34518 (46) | 0.11 (54) | 4.40 (20) | |
| 57 (5) | 3 | 763 (20) | 44.0 (32) | 39677 (41) | 0.09 (56) | 4.89 (19) |
Data are expressed as mean, and percent coefficient of variance is expressed in parentheses. AUC, total area under the concentration‐time curve; CL, clearance; Cmax, peak concentration; NC, not calculated; t1/2, terminal‐phase elimination half‐life (0.693/λz); Vss, steady‐state volume of distribution.