Abstract
IntroductionAfter 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. MethodsThe 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. ResultsThirty-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. ConclusionsBased 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.
Highlights
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
There was no increase in serum creatinine value, no decreases in eGFR and tacrolimus concentration/dose ratio
Whether Prograf® or Adoport®, whichever is used, it is important to continue taking the drug at the recommended dose and time
Summary
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 on the conversion of original tacrolimus to the generic tacrolimus, reported from Turkey. 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 primary 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 preconversion and final visit laboratory values
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