{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T01:56:55Z","timestamp":1792634215521,"version":"4.5.0"},"reference-count":42,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2023,11,21]],"date-time":"2023-11-21T00:00:00Z","timestamp":1700524800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100006483","name":"AbbVie","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100006483","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004328","name":"Genentech","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Brit J Clinical Pharma"],"published-print":{"date-parts":[[2024,3]]},"abstract":"<jats:sec><jats:title>Aims<\/jats:title><jats:p>Renal insufficiency is a common comorbidity in patients with haematological malignancies. This study aimed to assess how end\u2010stage renal disease (ESRD) might affect the pharmacokinetics of venetoclax, a Bcl\u20102 inhibitor, in participants with ESRD undergoing haemodialysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Venetoclax was administered as a single 100\u2010mg dose to 6 female participants with ESRD (estimated glomerular filtration rate\u2009&lt;15\u2009mL\/min) both prior to haemodialysis and between haemodialysis days and 7 healthy female participants with normal renal function (estimated glomerular filtration rate\u2009&gt;90\u2009mL\/min). Intensive pharmacokinetic and protein binding samples were collected from all participants. Arterial and venous samples were collected from ESRD participants during haemodialysis to assess the effect of haemodialysis on venetoclax pharmacokinetics. Pharmacokinetic parameters were estimated using noncompartmental methods.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There was no difference in plasma venetoclax concentrations between arterial and venous samples, suggesting that haemodialysis did not affect the pharmacokinetics of venetoclax. The fraction unbound (<jats:italic>f<\/jats:italic><jats:sub>u<\/jats:sub>) of venetoclax was ~2\u2010fold higher for participants with ESRD compared to participants with normal renal function. The unbound maximum plasma concentration and area under the plasma concentration\u2013time curve from time 0 to 48\u2009h were comparable between ESRD and normal function groups. The mean half\u2010life ranged from 10.4 to 12.2\u00a0h across groups, demonstrating that ESRD did not affect the half\u2010life of venetoclax. No new safety signals were observed during this study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>ESRD and dialysis do not alter unbound venetoclax plasma concentrations. No pharmacokinetics driven dose adjustment is needed for patients with renal insufficiency.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bcp.15935","type":"journal-article","created":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T09:01:04Z","timestamp":1697706064000},"page":"748-758","source":"Crossref","is-referenced-by-count":7,"title":["Venetoclax pharmacokinetics in participants with end\u2010stage renal disease undergoing haemodialysis"],"prefix":"10.1111","volume":"90","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5736-5989","authenticated-orcid":false,"given":"Behnam","family":"Noorani","sequence":"first","affiliation":[{"name":"AbbVie, Inc.  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