Clinical and safety outcomes of conversion original tacrolimus to generic tacrolimus in Turkish kidney transplant recipients

• Main Author: Emrah Günay
• Format: Article
• Language: English
• Published: Elsevier 2020-09-01
• Series: Transplantation Reports
• Subjects: Tacrolimus; Tacrolimus conversion; Generic tacrolimus; PrografⓇ; AdoportⓇ
• Online Access: http://www.sciencedirect.com/science/article/pii/S2451959620300184

Introduction: After the United States, The Food and Drug Administration approved the use of the first generic of the original tacrolimus in 2009, generic tacrolimus was preferred in many countries for cost-reducing reasons. This is the first study about the conversion of original to generic tacrolimus, reported from Turkey. Methods: The inclusion criteria of this single-center, retrospective study were (1) being ≥18 years old, (2) passing at least three months after kidney transplantation, (3) conversion from reference tacrolimus (PrografⓇ) to generic tacrolimus (AdoportⓇ). The endpoints were acute rejection, an increase in serum creatinine, decreases in e-GFR, tacrolimus level, tacrolimus concentration/dose ratio. We applied the paired T-test to analyze the pre-conversion and final visit laboratory values. Results: Thirty-six patients who agreed to use generic tacrolimus evaluated. The mean age was 39.8 years (± 11.6),% 52,7 were female,% 86,1 were living donor transplants. The patients followed up for 12 months [3-41]. There was no increase in serum creatinine value, no decreases in e-GFR and tacrolimus concentration/dose ratio. We observed a decrease in tacrolimus level (p = 0,037). There were 9 patients with positive BK-DNA. None of the patients needed a biopsy. Conclusions: Based on the results of our study, renal outcomes are safe and the drugs could be changed safely. Whether AdoportⓇ or PrografⓇ, whichever is used, it is important to take the drug at the recommended dose and time. The physician should be careful in dose adjustment after conversion, especially for those who are in the first year of transplantation.