Functional CYP3A variants affecting tacrolimus trough blood concentrations in Chinese renal transplant recipients

2021 ◽  
Author(s):  
Dina Chen ◽  
Huijie Lu ◽  
Weiguo Sui ◽  
Liqing Li ◽  
Jian Xu ◽  
...  
Keyword(s):  
Renal Transplant ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Blood Concentrations ◽  
Trough Blood

scholarly journals MO920TRANSITION FROM GENERIC TO BRAND TACROLIMUS IN TUNISIAN RENAL TRANSPLANT RECIPIENTS

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Dorra Amor ◽  
Sahtout Wissal ◽  
A Ellouz ◽  
Ameni Abderrahman ◽  
Awatef Azzabi ◽  
...  
Keyword(s):  
Renal Transplant ◽  
University Hospital ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Post Transplantation ◽  
Blood Concentrations ◽  
Transplant Patients ◽  
Trough Blood ◽  
Bioequivalence Testing ◽  
Adult Volunteers

Abstract Background and Aims Due to unavailability of the generic tacrolimus, commonly used in renal transplant patients in Tunisia, all renal transplant switched to the Brand. No previous studies have assessed the pharmacokinetic differences of this generic tacrolimus compared to the brand. The aim of the present study was to evaluate the effect of this switch on the tacrolimus dose (D) and on the dose-adjusted tacrolimus trough blood concentrations (C0/D) in Tunisian renal transplant recipients. Method For the 255 renal transplant monitored in biochemestry department of Sahloul University hospital, 808tacrolimus trough concentration (C0) were collected from october 2018 to February 2020 and were divided to 406 C0 determination before switch and 402 after switch. The dose and the post-transplantation period was recorded for each C0. Results The generic tacrolimus doses used were significantly higher compared to the brand: 0,12 mg/kg [0,02-0,6] vs 0,11 mg/kg [0,02-0,22] p<0,001 and this was reported in different post graft periods: 0,17 [0,03-0,22] vs 0,13 [0,06-0,22] p<0,001in the 3 first months after the transplantation and 0,11 [0,02-0,48] vs 0,08 [0,02-0,22] p<0,001 above.The C0/D were significantly lowe runder the the generic tacrolimus compared to the brand 48,34ng/ml per mg/kg/day [11,58-210,00] vs77,35ng/ml per mg/kg/day[19,38-221,67]; p<0,001 and this was reported in different post graft periods: 71,12ng/ml per mg/kg/day [6,80, 451,56] vs80,9750ng/ml per mg/kg/day [17,33-458,80] p=0,017 in the 3 first months after the transplantation and 71,12ng/ml per mg/kg/day [6,80, 451,56] vs80,9750ng/ml per mg/kg/day [17,33-458,80] p=0,017 above. Dose needed to reach target tacrolimus C0 seems to be higher with the generic tacrolimus compared to the brand. Conclusion Approval of a generic is dependent on bioequivalence testing in healthy adult volunteers after a single dose, however studies on renal graft recipient populations after chronic use are needed to assed bioequivalence in this special population.

Use of Leflunomide in the Treatment of Polyomavirus BK-Associated Nephropathy

2008 ◽  
Vol 42 (11) ◽  
pp. 1679-1685 ◽  
Author(s):  
Judy K Wu ◽  
Matthew T Harris
Keyword(s):  
Renal Transplant ◽  
Case Reports ◽  
Renal Transplant Recipients ◽  
Transplant Recipients ◽  
Blood Concentrations ◽  
Manual Search ◽  
Cell Counts ◽  
Drug Concentrations ◽  
Polyomavirus Bk

Objective: To review the available literature describing the use of leflunomide for the treatment of Polyomavirus BK-associated nephropathy (BKVAN) in renal transplant recipients. Data Sources: Relevant literature was obtained through MEDLINE (1950–May 2008) and Science Citation Index Expanded (1900–May 2008) by using search terms leflunomide, Arava, Polyomavirus, polyoma, BK virus, and transplant. Additional articles were identified through a manual search of the reference lists of the articles obtained. Study Selection and Data Extraction: All articles that were written in English and discussed leflunomide use for BKVAN In renal transplant recipients were evaluated. Case reports and in vitro studies were included in this review. Data Synthesis: BKVAN has emerged as a problematic infectious complication with limited treatment options in renal transplant recipients. Leflunomide, used off-label for refractory BKVAN, is postulated to possess both antiviral and immunosuppressive properties. Two in vitro culture studies, 5 case reports/series, 2 retrospective cohort studies, and 3 prospective observational trials that described leflunomide use in BKVAN were identified. Available literature suggests that leflunomide at target blood concentrations of around 40 mg/L, in addition to immunosuppressive reduction, reduces BK viremia/viruria and graft failure, with few dose-limiting adverse events. It is highly recommended that routine complete blood cell counts, hepatic function panels, and drug concentrations be monitored to detect toxicity. Conclusions: Leflunomide appears to be promising as adjunctive treatment of BKVAN in renal transplant patients. Due to the tack of controlled randomized trials, however, use of leflunomide as first-line treatment cannot be routinely recommended.

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