C
Grade
Irinotecan
PK studies in children (including infants) have been published. The effect of age was not studied in most of the studies. CL of the metabolite might be higher in younger children.
Level 2
PK model including infants or PopPK model without infants
| Author | Method | Number of Patients/Infants(<1yrs) | Age(yr), Median(range) | Age related findings | ||
|---|---|---|---|---|---|---|
| Crews (2002) | PopPK model (irinotecan and metabolites, compartments not described) | 31 / 0 | NS (3-21) | Effect of age was not studied. | ||
| Wagner (2004) | One compartment popPK model (additional compartments for metabolites) | 12 / 0 | 12.5 (1-23) | Effect of age was not studied. | ||
| Furman (2006) | One compartment popPK model (additional compartments for metabolites) (after oral administration) | 39 / 0 | 10 (3-19) | Effect of age was not studied. | ||
| Rodriguez-Galindo (2006) | One compartment popPK model (additional compartments for metabolites) | 11 / 0 | 10 (3-19) | Effect of age was not studied. Comparable PK to children in other studies. | ||
| Stewart (2007) | Multicompartment PopPK model (after i.v. and oral administration) | 74 / 0 | 10.4 (3.2-21.6) | Effect of age was not studied. | ||
| Thompson (2008) | Two compartment popPK model (additional compartments for metabolites). Allometric scaling for BW. Age and bilirubin included as covariates on SN-38 CL | 82 / 0 | NS (1-21) | Age and bilirubin significant covariates in SN-38 CL. CL (L/h) of SN-38 greater in patients <10 years old | ||
| Furman (2009) | Two compartment popPK model (additional compartments for metabolites) | 29 / 0 | 9 (1-21) | Effect of age was not studied. |
Level 3
Non-compartmental PK study or PK model without infants
| Author | Method | Number of Patients/Infants(<1yrs) | Age(yr), Median(range) | Age related findings | ||
|---|---|---|---|---|---|---|
| Gajjar (2003) | Non-compartmental pharmacokinetics | 35 / 0 | NS (3-21) | Effect of age was not studied. | ||
| Vassal (2003) | Non-compartmental pharmacokinetics | 77 / NS | 8 (0.9-18.6) | Effect of age was not studied. But CL values (L/h/m2) in these children were higher than those reported in adults | ||
| Bomgaars (2006) | Non-compartmental pharmacokinetics | 9 / 0 (Stratum 1). 9 / 0 (Stratum 2) | 11 (4-17) S1. 6 (2-15) S2 | Effect of age was not studied. | ||
| Bomgaars (2007) | Non-compartmental pharmacokinetics | 79 / 0 | 10 (2-23) | Effect of age was not studied. | ||
| Levy (2009) | Non-compartmental pharmacokinetics | 28 / 0 | 8.5 (1-21) | Effect of age was not studied. | ||
| Jannier (2020) | Non-compartmental pharmacokinetics | 42 / 0 | 10.5 (2-18) | Effect of age was not studied. |
Level 5
Mechanism-based reasoning or expert opinion
| Author | Method | Number of Patients/Infants(<1yrs) | Age(yr), Median(range) | Age related findings | ||
|---|---|---|---|---|---|---|
| Balis (2017) | Mechanism-based development of dose bands based on BSA intervals |
