title: Outcomes of Early Conversion From Prograf to Generic Tacrolimus in Adult Living Donor Liver Transplant Recipients.
abstract: The aim of this study was to evaluate the safety and efficacy of early conversion from the reference tacrolimus (Prograf; Astellas Pharma, Tokyo, Japan) to the generic tacrolimus (Tacrobell®:Chong Kun Dang Pharma, Seoul, Korea) in a cohort of adult living donor liver transplant (LDLT) recipients at a single institution. Between March 2010 and May 2012, a 1:1 dose conversion was performed 2 to 4 weeks after LDLT with dose adjustments targeted to achieve trough concentrations within the therapeutic range. Tacrolimus doses and trough levels, laboratory parameters, and adverse events were assessed. A total of 149 patients were enrolled. The median transplant duration was 22 days (range; 15-28 days). During a median follow-up of 17.3 months after conversion, there were 3 episodes of acute rejection, all of which responded to high-dose steroids. No adverse events were serious enough to stop the drug. In comparison with the control group maintained on Prograf, there were no significant differences in outcomes. In conclusion, early conversion from the reference to generic tacrolimus is safe and effective in stable adult LDLT patients.
authors: Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea. Electronic address: kshlj@hanmail.net.
authors: S H
authors: SH
authors: Kim
authors: Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
authors: S D
authors: SD
authors: Lee
authors: Department of Surgery, College of Medicine, Jeju National University, Jeju-do, Republic of Korea.
authors: Y K
authors: YK
authors: Kim
authors: Center for Liver Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea.
authors: S J
authors: SJ
authors: Park
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D057915:Drug Substitution / Q000009:adverse effects*; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007564:Japan; D016031:Liver Transplantation / Q000009:adverse effects / Q000379:methods*; D019520:Living Donors; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control; D056910:Republic of Korea; D012189:Retrospective Studies; D016559:Tacrolimus / Q000627:therapeutic use*
chemical_list: D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus