A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients
© 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 be...
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th-mahidol.513792020-01-27T16:27:31Z A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients Nuttasith Larpparisuth Soontorn Pinpaiboon Nartsiri Ratchawang Ratchawat Promraj Peenida Skulratanasak Attapong Vongwiwatana Nalinee Premasathian Mahidol University Faculty of Medicine, Siriraj Hospital, Mahidol University Medicine © 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. 2020-01-27T09:27:31Z 2020-01-27T09:27:31Z 2019-10-01 Article Transplantation Proceedings. Vol.51, No.8 (2019), 2629-2632 10.1016/j.transproceed.2019.03.063 18732623 00411345 2-s2.0-85071319447 https://repository.li.mahidol.ac.th/handle/123456789/51379 Mahidol University SCOPUS https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85071319447&origin=inward |
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Medicine 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 |
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© 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. |
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Mahidol University |
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Mahidol University Nuttasith Larpparisuth Soontorn Pinpaiboon Nartsiri Ratchawang Ratchawat Promraj Peenida Skulratanasak Attapong Vongwiwatana Nalinee Premasathian |
format |
Article |
author |
Nuttasith Larpparisuth Soontorn Pinpaiboon Nartsiri Ratchawang Ratchawat Promraj Peenida Skulratanasak Attapong Vongwiwatana Nalinee Premasathian |
author_sort |
Nuttasith Larpparisuth |
title |
A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients |
title_short |
A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients |
title_full |
A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients |
title_fullStr |
A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients |
title_full_unstemmed |
A Study of the Pharmacokinetic Comparison between the Generic and Original Form of Mycophenolate Mofetil Among Thai Renal Transplant Patients |
title_sort |
study of the pharmacokinetic comparison between the generic and original form of mycophenolate mofetil among thai renal transplant patients |
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2020 |
url |
https://repository.li.mahidol.ac.th/handle/123456789/51379 |
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1763496009951870976 |