Table 2.
Blinatumomab non-compartmental pharmacokinetic parameter estimates following continuous intravenous infusion in patients with bodyweight ≥ 45 and < 45 kg
| Population | Clearance | Vz | t½,Z | Dose | Cycle 1 Css |
|---|---|---|---|---|---|
| ≥ 45 kg |
3.15 (3.03) L/h n = 612 |
4.40 (2.53) L n = 55 |
2.10 (1.41) h n = 55 |
9 µg/day |
229 (360) pg/mL n = 333 |
| 28 µg/day |
615 (538) pg/mL n = 395 |
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| 5 µg/m2/day |
191 (79.8) pg/mL n = 62 |
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| 15 µg/m2/day |
608 (265) pg/mL n = 89 |
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| < 45 kg |
1.87 (1.96) L/h n = 56 |
3.48 (2.61) L n = 16 |
2.20 (1.56) h n = 16 |
9 µg/day |
174 (124) pg/mL n = 9 |
| 28 µg/day |
637 (554) pg/mL n = 12 |
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| 5 µg/m2/day |
157 (188) pg/mL n = 24 |
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| 15 µg/m2/day |
538 (403) pg/mL n = 32 |
Css steady-state concentration after cycle 1 administration of 5/15 µg/m2/day or 9/28 µg/day of blinatumomab, n sample size, t½,Z terminal half-life, Vz volume of distribution based on terminal phase