Date: Tuesday, May 5, 2015
Session Time: 5:30pm-6:30pm
Presentation Time: 5:30pm-6:30pm
Location: Exhibit Hall E
Elderly ( >60 years) recipients are being renal transplanted more frequently. The pharmacokinetics studies (PK) of immunosuppressive drugs in healthy volunteers, rarely, if ever, include old patients. We studied repeated 12 hour Everolimus (EVL) PK (0,20,40,60,90,120,180,240,360,480,600,720 min.) in 16 elderly (65±2years range 61-71years, 10 men; all white) at four different time points: PK1 (43±4days); PK2 (65±7days); PK3 (106±17days) and PK4 (206±40days). Patients were under EVL (target blood level:3-8ng/mL), Prednisone (5mg/day) and low-TAC (target:2-5 ng/ml). EVL replaced Mycophenolic sodium after 30 Post-tx day (Pod). The first EVL-PK (PK1) was performed 7±3days after EVL started. Mean TAC through levels at each time points were 7.2±3.8; 4.9±2.2; 4.9±2.2; 4.5±1.2 ng/mL. EVL was started at a median of 40 (95%CI:33-85) days after transplantation. Mean EVL daily dose did not differ among time points (3.8±1.3; 4.1±1.5; 3.6±1.4; 4.5±1.4 mg/day, respectively) and mean EVL through level (Cmin) also did not differ (C0: 4.5±1.3; 5.1±3.5; 4.6±2.4; 5.7±2.9 ng/mL, respectively). EVL-AUC0-720min did not change over time (96.4±20.8; 110.5±49.2; 102.8±49.2; 126.8±59.4 ng.h/mL, respectively). Usually, Tmax occurred at 81±40 min and average Cmax (20.6±10.5 ng/mL) also did not differ among time points. Elimination half-life (lambda_z) (15.29±10.52; 10.00±4.12; 10.91±4.32; 10.52±3.73 hours) and total body clearance for extravascular administration (Cl_F) also did not change over time (0.30±0.09; 0.30±0.16; 0.43±0.33; 0.32±0.27 L/h/Kg). All the PK parameters also did not differ statistically even when adjusted by EVL dose or by dose/Kg/day. These data indicate that elderly patients under low-TAC/EVL need a higher initial EVL dose than the one reported for CsA/EVL, and that in these patients the EVL-PK parameters are very stable overtime with no statistically significant changes in dose or exposure during the first year after renal transplantation.≥≥≥±≥±
To cite this abstract in AMA style:David-Neto E, Romano P, Agena F, Ebner P, Triboni A, Ramos F, Galante N, Lemos F. Pharmacokinetics of Everolimus (EVL) in Elderly Recipients Under Low-Tacrolimus(TAC)/Everolimus in the First Year After Renal Transplantation. Data from the NEverOLd Trial [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/pharmacokinetics-of-everolimus-evl-in-elderly-recipients-under-low-tacrolimustaceverolimus-in-the-first-year-after-renal-transplantation-data-from-the-neverold-trial/. Accessed January 17, 2020.
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