MO920TRANSITION FROM GENERIC TO BRAND TACROLIMUS IN TUNISIAN RENAL TRANSPLANT RECIPIENTS

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