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

• Published in: Drug design, development and therapy development and therapy, 2015-01, Vol.9, p.6139-6149
• Main Authors: Vollmar, Johanna, Bellmann, Maren Christina, Darstein, Felix, Hoppe-Lotichius, Maria, Mittler, Jens, Heise, Michael, Ruettger, Bernd, Weyer, Veronika, Zimmermann, Anca, Lang, Hauke, Galle, Peter R, Zimmermann, Tim
• Format: Article
• Language: English
• ISSN: 1177-8881
• DOI: 10.2147/DDDT.S92490

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 available regarding efficacy and safety of generic immunosuppressive agents. 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 registered (TAP) and Mowel registered (MOW). Patients were followed-up for 6 months. Results were compared retrospectively to 25 age- and sex-matched controls treated with the original brands. 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 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