NYMC Faculty Publications
The Pharmacokinetics and Safety of Twice Daily I.V. BU During Conditioning in Pediatric Allo-SCT Recipients
Author Type(s)
Faculty
DOI
10.1038/bmt.2012.105
Journal Title
Bone Marrow Transplantation
First Page
19
Last Page
25
Document Type
Article
Publication Date
1-1-2013
Department
Pediatrics
Keywords
Adolescent, Age Factors, Antineoplastic Agents, Alkylating, Busulfan, Child, Child, Preschool, Cohort Studies, Drug Administration Schedule, Drug Therapy, Combination, Female, Follow-Up Studies, Graft Survival, Half-Life, Humans, Infant, Infusions, Intravenous, Male, Metabolic Clearance Rate, Myeloablative Agonists, Stem Cell Transplantation, Transplantation Conditioning, Transplantation, Homologous
Disciplines
Medicine and Health Sciences | Oncology | Pediatrics
Abstract
Intravenous BU divided four times daily (q6 h) has been shown to be safe and effective in pediatric allo-SCT recipients. Though less frequent dosing is desirable, pharmacokinetic (PK) data on twice daily (q12 h) i.v. BU administration in pediatric allo-SCT recipients is limited. We prospectively examined the PK results in a cohort of pediatric allo-SCT recipients receiving i.v. BU q12 h as part of conditioning before allo-SCT. BU levels were obtained after the first dose of conditioning. PK parameter analysis (n=49) yielded the following 95% confidence intervals (CI₉₅): weight-normalized volume of distribution: 0.65-0.73 L/kg; t(1/2): 122-147 min; weight-normalized clearance (CL(n)): 3.4-4.3 mL/min/kg; and area under the curve: 1835-2180 mmol × min/L. From these results, a steady state concentration was calculated with CI₉₅ between 628-746 ng/mL. Comparison between recipients ≤4 vs >4 years old revealed significant differences in t(1/2) (mean: 115 vs 146 min, P=0.008) and CL(n) (mean: 4.4 vs 3.5 mL/min/kg, P=0.038). Intravenous BU q12 h had a comparable PK to i.v. BU q6 h PK seen in the literature, and in pediatric allo-SCT recipients, is a feasible, attractive alternative to i.v. q6h dosing.
Recommended Citation
Le Gall, J., Milone, M., Waxman, I., Shaw, L., Harrison, L., Duffy, D., van de Ven, C., Militano, O., Geyer, M., Morris, E., Bhatia, M., Satwani, P., George, D., Garvin, J., Bradley, M., Schwartz, J., Baxter-Lowe, L., & Cairo, M. (2013). The Pharmacokinetics and Safety of Twice Daily I.V. BU During Conditioning in Pediatric Allo-SCT Recipients. Bone Marrow Transplantation, 48 (1), 19-25. https://doi.org/10.1038/bmt.2012.105
