title: Impact of conversion from Advagraf to twice-daily generic tacrolimus in kidney transplant recipients: a single-center study.
abstract: BACKGROUND
  The conversion of twice-daily (Prograf) to once-daily tacrolimus (Advagraf) as well as from Prograf to a generic tacrolimus preparation was proved to be safe in kidney transplant patients. There are no published studies comparing the clinical outcomes of patients who were receiving Advagraf and were switched to generic preparations of tacrolimus.
  
  
  OBJECTIVE
  To evaluate the impact, safety profile, side effects, and renal graft function after the conversion of Advagraf to a generic preparation of tacrolimus.
  
  
  METHODS
  This prospective study was conducted over a 9-month period. The conversion to twice-daily generic tacrolimus was performed on a 1 mg:1 mg basis, total daily dose. We included 123 kidney transplant recipients (55% male). The mean (± SD) age was 49.9 ± 12 years. There were 100 (81%) Caucasian patients; the mean (± SD) time from transplantation to conversion was 4.6 ± 4.4 years.
  
  
  RESULTS
  A significant increase in blood levels (18%; P = .000) was reported. There was a necessary tacrolimus dose reduction of 17% (P = .000) and ≥ 3 blood trough levels to adjust the initial tacrolimus blood levels. The mean serum creatinine remained stable before conversion, at months 1 and 6 (1.40, 1.43, and 1.46 mg/dL, respectively). Significant adverse effects were reported in 9% of our patients. There were no episodes of acute rejection or graft loss during the study.
  
  
  CONCLUSIONS
  The conversion proved to be safe. A drug reduction was necessary to ensure stable renal function and good tolerability.
authors.affiliation: Nephrology and Renal Transplantation Department, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal. Electronic address: maria.melo83@gmail.com.
authors.forename: M J
authors.initials: MJ
authors.lastname: Melo
authors.affiliation: Nephrology and Renal Transplantation Department, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: J
authors.initials: J
authors.lastname: Gonçalves
authors.affiliation: Nephrology and Renal Transplantation Department, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: J O
authors.initials: JO
authors.lastname: Guerra
authors.affiliation: Nephrology and Renal Transplantation Department, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: A
authors.initials: A
authors.lastname: Santana
authors.affiliation: Nephrology and Renal Transplantation Department, Hospital de Santa Maria, Centro Hospitalar Lisboa Norte, Lisbon, Portugal.
authors.forename: C
authors.initials: C
authors.lastname: Nascimento
mesh_terms: D000328:Adult; D000368:Aged; D003692:Delayed-Action Preparations / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D016568:Drugs, Generic; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy*; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D007677:Kidney Function Tests; D016030:Kidney Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016559:Tacrolimus / Q000008:administration & dosage*; D013997:Time Factors; D066027:Transplant Recipients; D055815:Young Adult
chemical_list: D003692:Delayed-Action Preparations; D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus