Publication: A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients
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Issued Date
2019-10-01
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ISSN
18732623
00411345
00411345
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2-s2.0-85071319447
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Mahidol University
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SCOPUS
Bibliographic Citation
Transplantation Proceedings. Vol.51, No.8 (2019), 2629-2632
Suggested Citation
Nuttasith Larpparisuth, Soontorn Pinpaiboon, Nartsiri Ratchawang, Ratchawat Promraj, Peenida Skulratanasak, Attapong Vongwiwatana, Nalinee Premasathian A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients. Transplantation Proceedings. Vol.51, No.8 (2019), 2629-2632. doi:10.1016/j.transproceed.2019.03.063 Retrieved from: https://repository.li.mahidol.ac.th/handle/123456789/51379
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Title
A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients
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Abstract
© 2019 Elsevier Inc. Background: 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. Methods: 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. Results: 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. Conclusion: 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.