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Influence on Busilvex pharmacokinetics of clonazepam compared to previous phenytoin historical data.
Anticancer Res. 2010 Jul; 30(7):2977-84.AR

Abstract

This study investigated the effect of seizure prophylaxis on busulfan (Bu) plasma exposure. Twenty-four adult patients received an intravenous Bu-cyclophoshamide conditioning regimen prior to bone marrow transplantation. Busilvex (0.8 mg/kg) was administered every six hours during four consecutive days. Clonazepam (0.025 to 0.03 mg/kg/day as a continuous 12-h i.v. infusion) was administered at least 12 hours prior to i.v. Bu dosing and continued until 24 hours after the last dose. Pharmacokinetic (PK) data were compared with those previously collected in patients (n=127) treated with phenytoin for seizure prophylaxis. Through population PK analysis, a 10% average increase (coefficient of variation, RSE=5.35%) in total clearance of Bu was quantified when Bu was associated with clonazepam as compared to phenytoin, which was considered as not being clinically relevant. The suspected induction on Bu metabolism by phenytoin should have resulted in the opposite effect. The patient efficacy and safety profiles were comparable between the two cohorts.

Authors+Show Affiliations

Institute of Hematology Oncology, 08036 Bacelona, Spain.No 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
Journal Article
Multicenter Study

Language

eng

PubMed ID

20683042

Citation

Carreras, E, et al. "Influence On Busilvex Pharmacokinetics of Clonazepam Compared to Previous Phenytoin Historical Data." Anticancer Research, vol. 30, no. 7, 2010, pp. 2977-84.
Carreras E, Cahn JY, Puozzo C, et al. Influence on Busilvex pharmacokinetics of clonazepam compared to previous phenytoin historical data. Anticancer Res. 2010;30(7):2977-84.
Carreras, E., Cahn, J. Y., Puozzo, C., Kröger, N., Sanz, G., Buzyn, A., Bacigalupo, A., & Vernant, J. P. (2010). Influence on Busilvex pharmacokinetics of clonazepam compared to previous phenytoin historical data. Anticancer Research, 30(7), 2977-84.
Carreras E, et al. Influence On Busilvex Pharmacokinetics of Clonazepam Compared to Previous Phenytoin Historical Data. Anticancer Res. 2010;30(7):2977-84. PubMed PMID: 20683042.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Influence on Busilvex pharmacokinetics of clonazepam compared to previous phenytoin historical data. AU - Carreras,E, AU - Cahn,J Y, AU - Puozzo,C, AU - Kröger,N, AU - Sanz,G, AU - Buzyn,A, AU - Bacigalupo,A, AU - Vernant,J P, PY - 2010/8/5/entrez PY - 2010/8/5/pubmed PY - 2010/8/31/medline SP - 2977 EP - 84 JF - Anticancer research JO - Anticancer Res VL - 30 IS - 7 N2 - This study investigated the effect of seizure prophylaxis on busulfan (Bu) plasma exposure. Twenty-four adult patients received an intravenous Bu-cyclophoshamide conditioning regimen prior to bone marrow transplantation. Busilvex (0.8 mg/kg) was administered every six hours during four consecutive days. Clonazepam (0.025 to 0.03 mg/kg/day as a continuous 12-h i.v. infusion) was administered at least 12 hours prior to i.v. Bu dosing and continued until 24 hours after the last dose. Pharmacokinetic (PK) data were compared with those previously collected in patients (n=127) treated with phenytoin for seizure prophylaxis. Through population PK analysis, a 10% average increase (coefficient of variation, RSE=5.35%) in total clearance of Bu was quantified when Bu was associated with clonazepam as compared to phenytoin, which was considered as not being clinically relevant. The suspected induction on Bu metabolism by phenytoin should have resulted in the opposite effect. The patient efficacy and safety profiles were comparable between the two cohorts. SN - 1791-7530 UR - https://www.unboundmedicine.com/medline/citation/20683042/Influence_on_Busilvex_pharmacokinetics_of_clonazepam_compared_to_previous_phenytoin_historical_data_ L2 - http://ar.iiarjournals.org/cgi/pmidlookup?view=long&pmid=20683042 DB - PRIME DP - Unbound Medicine ER -