دورية أكاديمية
أعرض في EDS

Influence of Renal Function on Phosphoramide Mustard Exposure: A Nonlinear Mixed-Effects Analysis.

التفاصيل البيبلوغرافية
العنوان: Influence of Renal Function on Phosphoramide Mustard Exposure: A Nonlinear Mixed-Effects Analysis.
المؤلفون: Jaber MM; Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA., Takahashi T; Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA.; Boston Children's Hospital/Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Kirstein MN; Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA.; Masonic Cancer Center, University of Minnesota, Minneapolis, Minnesota, USA., Al-Kofahi M; Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA., Jacobson PA; Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA., Brundage RC; Department of Experimental and Clinical Pharmacology, University of Minnesota, Minneapolis, Minnesota, USA.
المصدر: Journal of clinical pharmacology [J Clin Pharmacol] 2023 Jan; Vol. 63 (1), pp. 135-142. Date of Electronic Publication: 2022 Sep 29.
نوع المنشور: Journal Article; Research Support, N.I.H., Extramural
اللغة: English
بيانات الدورية: Publisher: Wiley Country of Publication: England NLM ID: 0366372 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-4604 (Electronic) Linking ISSN: 00912700 NLM ISO Abbreviation: J Clin Pharmacol Subsets: MEDLINE
أسماء مطبوعة: Publication: 2013- : Oxford : Wiley
Original Publication: Stamford, Conn., Hall Associates.
مواضيع طبية MeSH: Hematopoietic Stem Cell Transplantation*, Humans ; Phosphoramide Mustards/metabolism ; Cyclophosphamide ; Kidney/metabolism
مستخلص: Phosphoramide mustard (PM) is the final cytotoxic metabolite formed from the parent compound cyclophosphamide through a complex metabolic pathway, primarily through hepatic metabolism. Little is known about the effect of renal elimination on the disposition of PM. We evaluated the effect of renal function on PM exposure after single doses of cyclophosphamide in 85 patients undergoing allogeneic hematopoietic cell transplantation using nonlinear mixed-effects modeling. Mixed linear and nonlinear elimination pathways were required to adequately describe the disposition of PM. Creatinine clearance (CrCL) was incorporated as a covariate associated with first-order elimination, representing renal clearance (Cl R ) of PM. For a 70-kg patient, Cl R was 14.9 L/h, Volume of distribution was 525 L, maximum rate was 81.2 mg/h, and the concentration to achieve 50% of maximum rate was 0.51 mg/L. We conducted simulations to explore the impact of CrCL as a measure of renal function and observed that when CrCL decreases from 120 to 40 mL/min, PM area under the plasma concentration-time curve (AUC) from time 0 to 8 hours and AUC increases by 9.2% and 80.9% on average after a single dose, respectively. Our data suggest that renal function has limited influence on PM exposure during the first 8 hours after dosing but has a large impact on the total exposure. Dose adjustment of cyclophosphamide may not be necessary in hematopoietic cell transplant recipients with moderate to severe kidney dysfunction to attain targeted exposures based on AUC from time 0 to 8 hours. However, dose reduction may be necessary if demonstrated at some future time that total AUC is a better surrogate for safety or toxicity.
(© 2022 Genentech Inc. The Journal of Clinical Pharmacology published by Wiley Periodicals LLC on behalf of American College of Clinical Pharmacology.)
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فهرسة مساهمة: Keywords: NONMEM; cyclophosphamide; nonlinear pharmacokinetics; phosphoramide mustard; population pharmacokinetics; renal function
المشرفين على المادة: 10159-53-2 (phosphoramide mustard)
0 (Phosphoramide Mustards)
8N3DW7272P (Cyclophosphamide)
تواريخ الأحداث: Date Created: 20220905 Date Completed: 20221215 Latest Revision: 20230413
رمز التحديث: 20230413
مُعرف محوري في PubMed: PMC10087276
DOI: 10.1002/jcph.2144
PMID: 36063026
قاعدة البيانات: MEDLINE
الوصف
تدمد:1552-4604
DOI:10.1002/jcph.2144