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Abstract: Objective: The objective of this study was to compare the pharmacokinetic profiles of a generic formulation with the innovator mycophenolate mofetil (MMF). Methods and Patients: Thirteen patients with stable renal grafts received MMF posttransplantation (mean, 32 months; confidence interval 95%: 51, 9–12, 36). Graft function improved significantly (serum creatinine levels 2.72 ± 1.75 mg/dL to 1.9 ± 0.66 and 1.79 ± 0.86 mg/dL at 12 and 30 months, respectively; P < .05). Three point (basal, 2, and 6 hours) profiles were performed. Five patients were switched 1:1 to a generic formulation for 60 days and repeating the pharmacokinetics were repeated. Afterwards, they returned to the innovator MMF for 45 days. Finally, all patients received generic MMF, repeating the pharmacokinetics between 15 days and 6 months later. Results: The area under the curve (AUC 0–6) of MPA was 52.68 ± 17.5 μg/mL*hr, with 61.5% of basal determinations (Co) under 5 μg/mL (4.08 ± 0.74). The Pearson correlation coefficient was high between both MMF formulations regarding FMPA AUC 0.768 (P < .005), Co (0.774; P < 0.05), and C6 (0.996; P < .005). GMPA AUC were similar (Pearson) 0.7 (P < .01), Co 0.99 (P < .01), and C6 0.86 (P < .01). C2 MMF levels were variable and showed poor correlation. FMPA AUC of generic and original formulations after 60 days had tight correlation. (Pearson 0.883; P < .025) and comparing 15 and 60 days postconversion with generic drug in the same patients were similar (Pearson 0.58; P < .025). Renal function at 12 months remained stable postconversion. Conclusions: Conversion to generic MMF in stable renal transplant recipients showed good clinical results. [Copyright &y& Elsevier]

Abstract: Following the change, in the way we monitored cyclosporine (CsA) levels in January 2000 namely from C0 to C2 concentrations, in renal ¿de novo¿ allograft recipients, some patients treated with concomitant ketoconazole experienced liver toxicity, a complication that had not been previously seen with CsA monitoring using C0. Therefore, we decided to compare the outcomes of patients transplanted using CsA levels monitored by C0 (1998 to 1999) who also had simultaneous C2 determinations (group A) with those of recipients transplanted after 2000 (group B). All received steroids, azathioprine, and CsA plus ketoconazole. Recipients were followed for at least a year after transplantation. Patients in group B showed higher CsA C2 levels, AUC concentrations, and drug doses during the immediate postsurgical period, and at 2 weeks as well as 4 and 6 months posttransplantation. Six group B patients (26%) but no group A recipients displayed, severe liver toxicity characterized by jaundice, elevated liver enzymes, with negative serological tests for CMV, HVC, and HVB. There was a correlation between the GOT and the C2 CsA levels; both normalized 15 to 55 days after CsA dose reduction. High C2 CsA levels, which have been recommended when the drug is used alone in renal transplantation, cannot be used in patients taking ketoconazole, because C2 neither represents nor correlates with AUC drug exposure. Thus high C2 levels may produce liver toxicity. [Copyright &y& Elsevier]