rFIX dosing and exposure days
| . | PK . | On-demand . | Prophylaxis* . | Surgery-related . | Total . |
|---|---|---|---|---|---|
| No. of patients | 56 | 55 | 47 | 20 | 56 |
| Total rFIX units (IU) administered per patient | |||||
| Cumulative | 907 264 | 8 552 140 | 9 252 060 | 2 212 170 | 20 923 634 |
| Median | 17 124 | 118 440 | 60 600 | 33 500 | 258 462 |
| Range | 2055-31 670 | 7200-810 200 | 1000-1 477 780 | 2200-423 700 | 11 778-2 141 525 |
| Dose (IU/kg) | |||||
| Median | 50.0 | 42.80 | 35.10 | 60.40 | 40.90 |
| Mean ± SD | 49.95 ± 3.53 | 46.56 ± 23.48 | 38.00 ± 17.06 | 66.25 ± 29.47 | 43.07 ± 21.32 |
| Range | 25.0-90.3 | 6.5-224.6 | 9.7-170.6 | 13.8-169.0 | 6.5-224.6 |
| No. of infusions | |||||
| Total | 263 | 2 758 | 3 909 | 432 | 7 362 |
| Median | 5.00 | 41.00 | 24.00 | 10.00 | 85.00 |
| Mean ± SD | 4.70 ± 1.04 | 50.15 ± 42.34 | 83.17 ± 130.28 | 21.60 ± 26.53 | 131.46 ± 128.69 |
| Range | 1-7 | 3-196 | 1-656 | 1-96 | 4-669 |
| No. of exposure days | |||||
| Total† | 263 | 2 633 | 3 620 | 320 | 6 823 |
| Median | 5.00 | 41.00 | 24.00 | 9.00 | 83.50 |
| Mean ± SD | 4.70 ± 1.04 | 47.87 ± 38.04 | 77.02 ± 108.28 | 16.00 ± 18.30 | 121.84 ± 103.27 |
| Range | 1-7 | 3-195 | 1-492 | 1-62 | 4-496 |
| . | PK . | On-demand . | Prophylaxis* . | Surgery-related . | Total . |
|---|---|---|---|---|---|
| No. of patients | 56 | 55 | 47 | 20 | 56 |
| Total rFIX units (IU) administered per patient | |||||
| Cumulative | 907 264 | 8 552 140 | 9 252 060 | 2 212 170 | 20 923 634 |
| Median | 17 124 | 118 440 | 60 600 | 33 500 | 258 462 |
| Range | 2055-31 670 | 7200-810 200 | 1000-1 477 780 | 2200-423 700 | 11 778-2 141 525 |
| Dose (IU/kg) | |||||
| Median | 50.0 | 42.80 | 35.10 | 60.40 | 40.90 |
| Mean ± SD | 49.95 ± 3.53 | 46.56 ± 23.48 | 38.00 ± 17.06 | 66.25 ± 29.47 | 43.07 ± 21.32 |
| Range | 25.0-90.3 | 6.5-224.6 | 9.7-170.6 | 13.8-169.0 | 6.5-224.6 |
| No. of infusions | |||||
| Total | 263 | 2 758 | 3 909 | 432 | 7 362 |
| Median | 5.00 | 41.00 | 24.00 | 10.00 | 85.00 |
| Mean ± SD | 4.70 ± 1.04 | 50.15 ± 42.34 | 83.17 ± 130.28 | 21.60 ± 26.53 | 131.46 ± 128.69 |
| Range | 1-7 | 3-196 | 1-656 | 1-96 | 4-669 |
| No. of exposure days | |||||
| Total† | 263 | 2 633 | 3 620 | 320 | 6 823 |
| Median | 5.00 | 41.00 | 24.00 | 9.00 | 83.50 |
| Mean ± SD | 4.70 ± 1.04 | 47.87 ± 38.04 | 77.02 ± 108.28 | 16.00 ± 18.30 | 121.84 ± 103.27 |
| Range | 1-7 | 3-195 | 1-492 | 1-62 | 4-496 |
Prophylaxis includes routine secondary prophylaxis 2 to 3 times each week for prevention of hemorrhage (this subgroup of patients is discussed separately in “Results”) as well as intermittent prophylactic use for the prevention of anticipated bleeding, such as bleeding that might occur following strenuous exercise.
A patient may be dosed more than once a day for different reasons.