Article ; Online: Influence of fludarabine on the pharmacokinetics of oral busulfan during pretransplant conditioning for hematopoietic stem cell transplantation.
Journal of clinical pharmacology
2013 Volume 53, Issue 11, Page(s) 1205–1211
Abstract: This study evaluated the influence of fludarabine on the pharmacokinetics of busulfan administered orally to patients receiving a conditioning regimen for hematopoietic allogeneic stem cell transplantation (HSCT). Twenty-six patients treated with oral ... ...
| Abstract | This study evaluated the influence of fludarabine on the pharmacokinetics of busulfan administered orally to patients receiving a conditioning regimen for hematopoietic allogeneic stem cell transplantation (HSCT). Twenty-six patients treated with oral busulfan (1 mg/kg/6 h for 4 days) were divided into two groups according to the concomitant administration of fludarabine (n = 11; 30 mg/m(2) for 5 days) or subsequent administration of cyclophosphamide (n = 15; 60 mg/kg for 2 days). Serial blood samples were collected on Day 4 of busulfan administration. Plasma busulfan concentrations were determined by HPLC-UV and the pharmacokinetic parameters were calculated using the WinNonlin program. Patients concomitantly treated with fludarabine showed reduced apparent clearance of busulfan (110.5 mL/h/kg vs. 157.4 mL/h/kg) and higher AUC0-6 (area under the plasma concentrations vs. time curve) than patients subsequently treated with cyclophosphamide (7.9 µg h/mL vs. 5.7 µg h/mL). No association was observed between busulfan AUC0-6 and clinical evolution of the patients. Although plasma busulfan concentrations were higher in patients receiving concomitant fludarabine, myelosuppression-related toxicity was less frequent than in patients treated with busulfan and cyclophosphamide. The results suggest that patients treated with fludarabine should receive 30% lower busulfan doses during conditioning protocols for HSCT. |
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| MeSH term(s) | Adolescent ; Adult ; Alkylating Agents/administration & dosage ; Alkylating Agents/blood ; Alkylating Agents/pharmacokinetics ; Busulfan/administration & dosage ; Busulfan/blood ; Busulfan/pharmacokinetics ; Cyclophosphamide/administration & dosage ; Drug Interactions ; Female ; Hematopoietic Stem Cell Transplantation ; Humans ; Male ; Middle Aged ; Myeloablative Agonists/administration & dosage ; Transplantation Conditioning ; Vidarabine/administration & dosage ; Vidarabine/analogs & derivatives ; Young Adult |
| Chemical Substances | Alkylating Agents ; Myeloablative Agonists ; Cyclophosphamide (8N3DW7272P) ; Vidarabine (FA2DM6879K) ; Busulfan (G1LN9045DK) ; fludarabine (P2K93U8740) |
| Language | English |
| Publishing date | 2013-11 |
| Publishing country | England |
| Document type | Clinical Trial ; Journal Article ; Research Support, Non-U.S. Gov't |
| ZDB-ID | 188980-1 |
| ISSN | 1552-4604 ; 0091-2700 ; 0021-9754 |
| ISSN (online) | 1552-4604 |
| ISSN | 0091-2700 ; 0021-9754 |
| DOI | 10.1002/jcph.130 |
| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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