{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,7]],"date-time":"2025-11-07T19:16:57Z","timestamp":1762543017663,"version":"build-2065373602"},"reference-count":36,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2019,4,15]],"date-time":"2019-04-15T00:00:00Z","timestamp":1555286400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100000038","name":"U.S. Food and Drug Administration","doi-asserted-by":"publisher","award":["HHSF223201310224C"],"award-info":[{"award-number":["HHSF223201310224C"]}],"id":[{"id":"10.13039\/100000038","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["accpjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pharmacotherapy"],"published-print":{"date-parts":[[2019,5]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p>To compare clinical and safety outcomes of transplant recipients converted between different tacrolimus formulations to those patients who remained on a single formulation in an outpatient environment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methodology<\/jats:title><jats:p>This was a single\u2010center, retrospective cohort study at a large tertiary care medical center with an associated institutional outpatient pharmacy system. Adult transplant recipients with institutional pharmacy refill from August 1, 2009, to May 31, 2016, were assessed. Patients were allocated into four separate groups: Group (A) innovator tacrolimus (no conversion), Group (B) generic tacrolimus (no conversion), Group (C) single conversion (from innovator to single generic or from generic to innovator tacrolimus), and Group (D) multiple conversions. Index date was either the date of first tacrolimus product conversion (Groups C and D) or a pre\u2010specified post\u2010transplant time (Groups A and B).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 100 patients were included in the analysis, 63% were male, 62% were Caucasian, and 59% were renal transplant recipients. When compared between groups, linear trends in dose\u2010normalized tacrolimus levels were similar in the pre\u2010index date period (p=0.52) and in the post\u2010index date period (p=0.08). When groups were compared individually, linear trends in dose\u2010normalized tacrolimus levels were significantly different pre\u2010 versus post\u2010index date for Group B (p=0.008). There were no differences in the linear trends of dose\u2010normalized tacrolimus levels across the other groups (p&gt;0.05 for all). After the index date, 43% of patients across all groups required tacrolimus dose modification with no differences by group (p=0.32). Allograft function and hospitalizations were similar across all groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Conversion between tacrolimus generic formulations has been suggested to be unsafe. This study demonstrates that switching tacrolimus products in post\u2010transplant recipients does not alter dose\u2010normalized tacrolimus trough concentrations, renal or hepatic function, pathology, or hospitalizations.<\/jats:p><\/jats:sec>","DOI":"10.1002\/phar.2260","type":"journal-article","created":{"date-parts":[[2019,3,20]],"date-time":"2019-03-20T07:37:33Z","timestamp":1553067453000},"page":"564-575","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Evaluation of Clinical and Safety Outcomes Following Uncontrolled Tacrolimus Conversion in Adult Transplant Recipients"],"prefix":"10.1002","volume":"39","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3804-6517","authenticated-orcid":false,"given":"Alicia","family":"Lichvar","sequence":"first","affiliation":[{"name":"Division of Transplantation Department of Surgery University of Cincinnati Cincinnati Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Simon","family":"Tremblay","sequence":"additional","affiliation":[{"name":"Department of Surgery Division of Transplantation University of Cincinnati Cincinnati OH"},{"name":"Department of Environmental Health Division of Epidemiology University of Cincinnati Cincinnati OH"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Devanshi","family":"Naik","sequence":"additional","affiliation":[{"name":"University of Cincinnati, James L. Winkle College of Pharmacy Cincinnati Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jessi","family":"Lipscomb","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Epidemiology Cincinnati Children's Hospital Medical Center Cincinnati Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eileen","family":"King","sequence":"additional","affiliation":[{"name":"Division of Biostatistics and Epidemiology Cincinnati Children's Hospital Medical Center Cincinnati Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alexander A.","family":"Vinks","sequence":"additional","affiliation":[{"name":"Clinical Pharmacology Cincinnati Children's Hospital Medical Center Cincinnati Ohio"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Uwe","family":"Christians","sequence":"additional","affiliation":[{"name":"Department of Anesthesiology University of Colorado, Anschutz Medical Campus Denver Colorado"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rita R.","family":"Alloway","sequence":"additional","affiliation":[{"name":"Department of Surgery Division of Transplantation University of Cincinnati Cincinnati OH"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,4,15]]},"reference":[{"key":"e_1_2_6_2_1","unstructured":"Astellas Pharma US Inc.Prograf(R) [package insert].Northbrook IL; May2015[December 6 2016]. 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