2012
DOI: 10.1038/bmt.2012.105
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The pharmacokinetics and safety of twice daily i.v. BU during conditioning in pediatric allo-SCT recipients

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 … Show more

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Cited by 6 publications
(5 citation statements)
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References 26 publications
(34 reference statements)
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“…Lung shielding was not used for TBI-containing regimens. Busulfan-containing conditioning regimens utilized busulfan pharmacokinetic dose adjustment and were targeted to achieve 600 to 900 ng/mL steady-state concentration, as we have previously reported [20,23]. RTC regimens were fludarabine-based (150 to 180 mg/m 2 ) as follows: fludarabine/busulfan (12.8 mg/kg in patients > 4 years of age, 16 mg/kg in patients ≤ 4 years of age) and fludarabine/cyclophosphamide, as we have previously reported [23].…”
Section: Methodsmentioning
confidence: 99%
“…Lung shielding was not used for TBI-containing regimens. Busulfan-containing conditioning regimens utilized busulfan pharmacokinetic dose adjustment and were targeted to achieve 600 to 900 ng/mL steady-state concentration, as we have previously reported [20,23]. RTC regimens were fludarabine-based (150 to 180 mg/m 2 ) as follows: fludarabine/busulfan (12.8 mg/kg in patients > 4 years of age, 16 mg/kg in patients ≤ 4 years of age) and fludarabine/cyclophosphamide, as we have previously reported [23].…”
Section: Methodsmentioning
confidence: 99%
“…15 BU pharmacokinetic studies were performed for all patients with a target steady state concentration (C ss ) of 600-900 ng/mL. 17,18 For patient 13, melphalan (70 mg/m 2 /day, days − 8 and − 7) was substituted for BU due to the development of respiratory distress with the first dose of BU.…”
Section: Hla Typingmentioning
confidence: 99%
“…31 Many of these strategies also employ the use of shorter dosing intervals (eg, every 6 or 12 hours), which provides the ability to adjust busulfan doses earlier in the conditioning regimen once PK results from the first dose become available. 2,[31][32][33][34] However, a recent review attempted simulations based on several published models and revealed that an every-6-hour dosing AUC target of 900-1500 μmol·min/L was still reached in only 51% to 74% of pediatric patients. 31 The FDA package insert provides a suggested dosing nomogram for IV busulfan dosing based on actual body weight from a population PK model developed by Booth et al 34 and is predicted to reach every-6-hour dosing AUC targets of 900-1350 μmol·min/L in ß60% of patients.…”
Section: Discussionmentioning
confidence: 99%