TABLE 2.
Tacrolimus pharmacokinetics: daily dose, C0, and dose adjustments
| Baseline |
IR‐tacrolimus n = 92 |
ER‐tacrolimus n = 47 |
LCP‐tacrolimus n = 45 |
|
|---|---|---|---|---|
| Tacrolimus dose, mg/day | 5.2 (3.7) | 5.0 (3.9) | 5.6 (4.1) | 3.3 (2.6) |
| Tacrolimus C0, ng/ml | 6.0 (1.5) | 6.0 (1.7) | 5.4 (1.5) | 5.7 (1.6) |
| Tacrolimus C0/dose, ng/ml/mg | 1.6 (1.0) | 1.7 (1.1) | 1.4 (0.9) | 2.4 (1.4) |
| Number of tacrolimus C0 levels | ||||
| 4 | 7 (7.6%) | 2 (4.3%) | 4 (8.9%) | |
| 5 | 28 (30.4%) | 9 (19.1%) | 10 (22.2%) | |
| 6 | 46 (50%) | 26 (55.3%) | 24 (53.3%) | |
| ≥7 | 11 (12%) | 10 (21.3%) | 7 (15.6%) | |
| No. of dose adjustments | ||||
| 0 | 62 (67.4%) | 22 (46.8%) | 27 (60%) | |
| 1 | 22 (23.9%) | 19 (40.4%) | 9 (20%) | |
| 2 | 6 (6.5%) | 5 (5.4%) | 5 (11.1%) | |
| ≥3 | 2 (2.2%) | 1 (2.1%) | 4 (8.9%) | |
| First tacrolimus C0 | ||||
| In target range (%) | 84 (91.3) | 38 (80.9) | 36 (80) | |
| Below target range (%) | 1 (1.1) | 9 (19.1) | 3 (6.7) | |
| Above target range (%) | 7 (7.6) | 0 | 6 (13.3) |
Data is presented as mean ± SD.
Data represent tacrolimus dose and tacrolimus trough level at the end of the 6‐month treatment period.
Abbreviations: ER, extended release; IR, immediate release; LCP, LifeCyclePharma.