Dosing algorithm for deferasirox and deferoxamine according to baseline LIC and average daily doses by LIC category
. | Baseline LIC, mg Fe/g dw (regardless of method) . | . | . | . | |||
|---|---|---|---|---|---|---|---|
. | LIC 3 mg Fe/g dw or less . | LIC above 3 mg Fe/g dw-7 mg Fe/g dw . | LIC above 7 mg Fe/g dw-14 mg Fe/g dw . | LIC above 14 mg Fe/g dw . | |||
| Deferasirox | |||||||
| No. patients | 15 | 78 | 84 | 119 | |||
| Protocol assigned dose, mg/kg | 5 | 10 | 20 | 30 | |||
| Baseline LIC, mean ± SD | 2.5 ± 0.21 | 4.9 ± 1.08 | 10.6 ± 2.08 | 24.2 ± 7.82 | |||
| Average daily dose, mg/kg/d* | |||||||
| Mean ± SD | 6.2 ± 1.6 | 10.2 ± 1.2 | 19.4 ± 1.7 | 28.2 ± 3.5 | |||
| Median (range) | 5.0 (4.3-8.7) | 10.0 (5.6-16.3) | 20.0 (9.9-21.4) | 30.0 (11.0-30.0) | |||
| Deferoxamine | |||||||
| No. patients | 14 | 79 | 91 | 106 | |||
| Protocol assigned dose, mg/kg† | 20-30 | 25-35 | 35-50 | ≥50 | |||
| Baseline LIC, mean ± SD | 2.7 ± 0.28 | 5.2 ± 1.22 | 10.6 ± 2.03 | 23.9 ± 8.06 | |||
| Average daily dose, mg/kg/d* | |||||||
| Mean ± SD | 33.9 ± 9.9 | 36.7 ± 9.2 | 42.4 ± 6.6 | 51.6 ± 5.8 | |||
| Median (range) | 30.0 (23.0-52.6) | 35.0 (20.0-75.6) | 40.8 (21.0-70.0) | 51.0 (30.0-66.1) | |||
| Ratio of mean deferasirox dose to mean deferoxamine dose | 1:5.5 | 1:3.6 | 1:2.2 | 1:1.8 | |||
. | Baseline LIC, mg Fe/g dw (regardless of method) . | . | . | . | |||
|---|---|---|---|---|---|---|---|
. | LIC 3 mg Fe/g dw or less . | LIC above 3 mg Fe/g dw-7 mg Fe/g dw . | LIC above 7 mg Fe/g dw-14 mg Fe/g dw . | LIC above 14 mg Fe/g dw . | |||
| Deferasirox | |||||||
| No. patients | 15 | 78 | 84 | 119 | |||
| Protocol assigned dose, mg/kg | 5 | 10 | 20 | 30 | |||
| Baseline LIC, mean ± SD | 2.5 ± 0.21 | 4.9 ± 1.08 | 10.6 ± 2.08 | 24.2 ± 7.82 | |||
| Average daily dose, mg/kg/d* | |||||||
| Mean ± SD | 6.2 ± 1.6 | 10.2 ± 1.2 | 19.4 ± 1.7 | 28.2 ± 3.5 | |||
| Median (range) | 5.0 (4.3-8.7) | 10.0 (5.6-16.3) | 20.0 (9.9-21.4) | 30.0 (11.0-30.0) | |||
| Deferoxamine | |||||||
| No. patients | 14 | 79 | 91 | 106 | |||
| Protocol assigned dose, mg/kg† | 20-30 | 25-35 | 35-50 | ≥50 | |||
| Baseline LIC, mean ± SD | 2.7 ± 0.28 | 5.2 ± 1.22 | 10.6 ± 2.03 | 23.9 ± 8.06 | |||
| Average daily dose, mg/kg/d* | |||||||
| Mean ± SD | 33.9 ± 9.9 | 36.7 ± 9.2 | 42.4 ± 6.6 | 51.6 ± 5.8 | |||
| Median (range) | 30.0 (23.0-52.6) | 35.0 (20.0-75.6) | 40.8 (21.0-70.0) | 51.0 (30.0-66.1) | |||
| Ratio of mean deferasirox dose to mean deferoxamine dose | 1:5.5 | 1:3.6 | 1:2.2 | 1:1.8 | |||
For deferasirox, n = 296; for deferoxamine, n = 290.
Average daily doses are reported for the 1-year period of drug administration. For deferoxamine, the reported doses are normalized to those administered with a 5-day regimen.
Patients in the 2 lower LIC groups (LIC ≤ 3 and >3-7 mg Fe/g dw) who were randomized to treatment with deferoxamine were allowed to continue on their current deferoxamine dosage, even if this was higher than recommended in this table.