A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients

• Published in: Transplantation proceedings Vol. 51; no. 8; pp. 2629 - 2632
• Main Authors: Larpparisuth, Nuttasith, Pinpaiboon, Soontorn, Ratchawang, Nartsiri, Promraj, Ratchawat, Skulratanasak, Peenida, Vongwiwatana, Attapong, Premasathian, Nalinee
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.10.2019
• Subjects: Adult; Area Under Curve; Drug Therapy, Combination; Drugs, Generic - pharmacokinetics; Female; Follow-Up Studies; Humans; Immunosuppressive Agents - pharmacokinetics; Kidney Transplantation; Male; Middle Aged; Mycophenolic Acid - pharmacokinetics; Postoperative Period; Prospective Studies; Steroids - administration & dosage; Tacrolimus - administration & dosage; Thailand; Treatment Outcome; Thailand
• ISSN: 0041-1345; 1873-2623
• DOI: 10.1016/j.transproceed.2019.03.063

Mycophenolic acid (MPA) is one of the main immunosuppressive regimens used after kidney transplantation (KT). The less expensive, generic form of mycophenolate mofetil (MMF) (Immucept®) is recently available in Thailand. Comparisons of the pharmacokinetic profiles between the original and generic forms of MMF among post-KT patients are limited. This prospective cohort study recruited KT patients receiving stable doses of MMF 1000 mg daily along with tacrolimus and steroids. All participants were prescribed CellCept® 500 mg every 12 hours for at least 2 weeks before measuring the MPA area under the curve from 0 to 12 hours (AUC0-12). CellCept® was switched to Immucept® 500 mg every 12 hours for 2 weeks and MPA AUC0-12 was remeasured. Twenty patients with a median follow-up time of 35.4 (11.13–198.83) months were enrolled. Mean MPA AUC0-12 of Immucept® was higher than CellCept® without statistical significance (48.27 ± 2.31 μg⋅hr/mL vs 42.19±15.20 μg⋅hr/mL; P value = .59). No difference was revealed regarding the minimum measured concentration, maximum measured concentration, and time point with maximum concentration between both drugs. While on CellCept®, 5 patients (25%) had an MPA AUC0-12 < 30.0 μg⋅hr/mL, but 3 patients (15%) had MPA AUC0-12 < 30.0 μg⋅hr/mL when receiving Immucept®. However, 3 (15%) and 6 (30%) patients had MPA AUC0-12 > 60.0 μg⋅hr./mL when treated with CellCept® and Immucept®, respectively. Generic MMF exhibited a comparable pharmacodynamic profile as the original formulation. MPA AUC0-12 was more than 30.0 μg⋅hr/mL among most patients receiving MMF 1000 mg/day. •Less expensive generic mycophenolate mofetil (MMF, Immucept®) provided a comparable mycophenolic acid area under the curve (MPA AUC) as the original formulation.•Target MPA AUC was achieved in most Thai kidney transplant patients receiving mycophenolate mofetil (MMF) 500.0 mg twice daily.•The abbreviated model to predict MPA AUC0-12 of MMF had high precision.•The use of bioequivalent, generic MMF is economically suitable for a middle- to low-income country.