Converting to a Generic Formulation of Mycophenolate Mofetil in Stable Kidney Transplant Recipients: 1 Year of Drug Surveillance and Outcome

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.