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Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients.
J Clin Pharmacol. 2007 Jan; 47(1):101-11.JC

Abstract

The objective of this study was to characterize the pharmacokinetics (PK) of intravenous busulfan in pediatric patients and provide dosing recommendations. Twenty-four pediatric patients were treated with intravenous busulfan, 1.0 or 0.8 mg/kg for ages < or = 4 years or > 4 years, respectively, 4 times a day for 4 days. Dense PK sampling was performed. Body weight, age, gender, and body surface area were explored for effects on PK, and Monte Carlo simulations were performed to assess different dosing regimens. The PK of intravenous busulfan was described by a 1-compartment model with clearance of 4.04 L/h/20 kg and volume of distribution of 12.8 L/20 kg. Simulations indicated that the mg/kg and mg/m2 regimens were similar and achieved the desired target exposure in approximately 60% of patients. This model suggests that patients < or = 12 kg should be dosed at 1.1 mg/kg and those > 12 kg dosed at 0.8 mg/kg. Therapeutic drug monitoring and dose adjustment will further improve therapeutic targeting.

Authors+Show Affiliations

Food and Drug Administration, Office of Clinical Pharmacology, Division of Clinical Pharmacology 5, 10903 New Hampshire Avenue, Building 21, Room 3668, Silver Spring, MD 20993-0002, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study

Language

eng

PubMed ID

17192508

Citation

Booth, Brian P., et al. "Population Pharmacokinetic-based Dosing of Intravenous Busulfan in Pediatric Patients." Journal of Clinical Pharmacology, vol. 47, no. 1, 2007, pp. 101-11.
Booth BP, Rahman A, Dagher R, et al. Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients. J Clin Pharmacol. 2007;47(1):101-11.
Booth, B. P., Rahman, A., Dagher, R., Griebel, D., Lennon, S., Fuller, D., Sahajwalla, C., Mehta, M., & Gobburu, J. V. (2007). Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients. Journal of Clinical Pharmacology, 47(1), 101-11.
Booth BP, et al. Population Pharmacokinetic-based Dosing of Intravenous Busulfan in Pediatric Patients. J Clin Pharmacol. 2007;47(1):101-11. PubMed PMID: 17192508.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients. AU - Booth,Brian P, AU - Rahman,Atiqur, AU - Dagher,Ramzi, AU - Griebel,Donna, AU - Lennon,Shari, AU - Fuller,David, AU - Sahajwalla,Chandra, AU - Mehta,Mehul, AU - Gobburu,Jogarao V S, PY - 2006/12/29/pubmed PY - 2007/3/3/medline PY - 2006/12/29/entrez SP - 101 EP - 11 JF - Journal of clinical pharmacology JO - J Clin Pharmacol VL - 47 IS - 1 N2 - The objective of this study was to characterize the pharmacokinetics (PK) of intravenous busulfan in pediatric patients and provide dosing recommendations. Twenty-four pediatric patients were treated with intravenous busulfan, 1.0 or 0.8 mg/kg for ages < or = 4 years or > 4 years, respectively, 4 times a day for 4 days. Dense PK sampling was performed. Body weight, age, gender, and body surface area were explored for effects on PK, and Monte Carlo simulations were performed to assess different dosing regimens. The PK of intravenous busulfan was described by a 1-compartment model with clearance of 4.04 L/h/20 kg and volume of distribution of 12.8 L/20 kg. Simulations indicated that the mg/kg and mg/m2 regimens were similar and achieved the desired target exposure in approximately 60% of patients. This model suggests that patients < or = 12 kg should be dosed at 1.1 mg/kg and those > 12 kg dosed at 0.8 mg/kg. Therapeutic drug monitoring and dose adjustment will further improve therapeutic targeting. SN - 0091-2700 UR - https://www.unboundmedicine.com/medline/citation/17192508/Population_pharmacokinetic_based_dosing_of_intravenous_busulfan_in_pediatric_patients_ L2 - https://doi.org/10.1177/0091270006295789 DB - PRIME DP - Unbound Medicine ER -