title: De novo use of generic tacrolimus in liver transplantation - a single center experience with one-yr follow-up.
abstract: Use of generic tacrolimus in liver transplantation (LT) could result in cost savings. Generic tacrolimus has been shown to be bioequivalent to innovator tacrolimus in healthy volunteers and renal transplant patients. There are limited data on the de novo use of generic tacrolimus in LT. This study aimed to determine whether the de novo use of generic tacrolimus (Adoport, Sandoz,UK) was associated with differences in outcomes, safety, and cost compared with innovator tacrolimus (Prograf, Astellas, Japan).
  
  
  METHODS
  Patients were studied before and after a programmatic change from de novo IS with Prograf to Adoport. Outcomes, tacrolimus levels, doses, and costs were compared for the first-yr post-LT.
  
  
  RESULTS
  Ninety-four patients were studied, 46 Prograf, 48 Adoport. No significant differences in rejection, cytomegalovirus infection, acute kidney injury, sepsis, or graft loss were observed between groups. Tacrolimus costs were significantly reduced with the de novo use of Adoport. Day 14 dose normalized levels in Adoport patients showed significant variation but at the day 30 and one yr, there were no significant differences in the doses or levels of tacrolimus between groups.
  
  
  CONCLUSIONS
  Adoport is safe and effective compared to Prograf when used de novo in LT patients. Tacrolimus costs were significantly reduced by the use of Adoport.
authors.affiliation: The Royal Free Sheila Sherlock Liver Centre and University Department of Surgery, Royal Free Hospital, London, UK.
authors.forename: E
authors.initials: E
authors.lastname: Dannhorn
authors.forename: M
authors.initials: M
authors.lastname: Cheung
authors.forename: S
authors.initials: S
authors.lastname: Rodrigues
authors.forename: H
authors.initials: H
authors.lastname: Cooper
authors.forename: D
authors.initials: D
authors.lastname: Thorburn
authors.forename: D
authors.initials: D
authors.lastname: Patch
authors.forename: A K
authors.initials: AK
authors.lastname: Burroughs
authors.forename: J
authors.initials: J
authors.lastname: O'Beirne
mesh_terms: D000328:Adult; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000209:etiology; D006085:Graft Survival; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D007564:Japan; D008107:Liver Diseases / Q000150:complications / Q000601:surgery*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011379:Prognosis; D011446:Prospective Studies; D012189:Retrospective Studies; D012307:Risk Factors; D016559:Tacrolimus / Q000627:therapeutic use*
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D016559:Tacrolimus
keywords: generic; immunosuppression; liver transplantation; tacrolimus