Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation

Efficacy and safety of a conversion from the original tacrolimus and mycophenolate mofetil to the generics Tacpan® and Mowel® after liver transplantation

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Johanna Vollmar,1 Maren Christina Bellmann,1 Felix Darstein,1 Maria Hoppe-Lotichius,2 Jens Mittler,2 Michael Heise,2 Bernd Rüttger,3 Veronika Weyer,4 Anca Zimmermann,5 Hauke Lang,2 Peter R Galle,1 Tim Zimmermann1 1First Department of Internal Medicine, Gastroenterology and Hepatology, Johannes Gutenberg University, Mainz, Germany; 2Department of Hepatobiliary and Transplantation Surgery, Johannes Gutenberg University, Mainz, Germany; 3Panacea Biotec Germany GmbH, Munich, Germany; 4Institute for Medical Biostatistics, Epidemiology and Informatics (IMBEI), University Medical Center, Johannes Gutenberg University, Mainz, Germany; 5First Department of Internal Medicine, Endocrinology and Metabolic Diseases, Johannes Gutenberg University, Mainz, Germany Background: Expensive pharmaceuticals are a major reason for cost intensive health care systems.Long-term immunosuppressive therapy plays a relevant role after organ transplantation.Patents of original drugs have expired and cheaper products are available.

Little data are ps5 edmonton in stock available regarding efficacy and safety of generic immunosuppressive agents.Methods: In this prospective study, 25 patients, who were clinically stable for a minimum of 2 years after liver transplantation, were converted from the original formulations of tacrolimus (TAC) and mycophenolate mofetil to the generics Tacpan® (TAP) and Mowel® (MOW).Patients were followed-up for 6 months.

Results were compared retrospectively to 25 age- and sex-matched controls treated with the original brands.Results: In the matched-pair analysis of TAC trough level/dose ratio, no significant difference was found between TAP/MOW and TAC/mycophenolate mofetil groups.No acute rejection occurred in either polar blue dunks shirt group.

In total, 17 patients reported mild side effects in the TAP/MOW group.The most common side effects were gastrointestinal symptoms.Intra-individual analysis of costs revealed a considerable cost reduction in the TAP/MOW group (in median 25.

03%; P<0.001).Conclusion: In summary, the use of the generics TAP/MOW is effective and seems to be safe and cost-efficient in stable liver-transplantation patients.

Keywords: immunosuppression, liver transplantation, generics, tacrolimus, mycophenolate mofetil.