title: Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients.
abstract: BACKGROUND
  Generic immunosuppressants may offer economic advantages, but their use is still controversial. At our center, 55 heart transplant patients were switched from CellCept(®) to Myfenax Teva(®) (MT) (n = 51, 18% female, 8.1 ± 6.6 yr post-transplantation) and/or Prograf(®) to Tacrolimus Sandoz(®) (TS) (n = 17, 41% female, 6.6 ± 5.8 yr post-transplantation).
  
  
  METHODS
  We conducted an acute monitoring and a retrospective follow-up with regard to safety and efficacy. Acute cellular rejections (ACRs) on endomyocardial biopsies (EMBs) four wk after the MT switch were specifically compared to a matched retrospective control group.
  
  
  RESULTS
  Tacrolimus C0 levels (TS switch) as well as hemoglobin, leukocytes, and thrombocytes (MT switch) did not change (p = NS) during the three wk after each respective switch (8.7 ± 2.9 vs. 8.4 ± 1.9 μg/L, 129.1 ± 12.6 vs. 130.1 ± 12.8 g/L, 6.3 vs. 6.2 × 10(9) /L, and 217.4 ± 56.6 vs. 219.3 ± 61.8 × 10(9) /L, respectively). 0% of the EMBs in the MT switch vs. 3% of the EMBs in the control group showed ACR>grade 1R (p = NS). After six months, survival was 96% (MT switch) and 100% (TS switch), and the frequency of severe ACR was low. Safety parameters measured at the next annual follow-up were also stable following each switch.
  
  
  CONCLUSIONS
  Switching to MT and/or TS several years after heart transplantation appeared safe in the short-term perspective, showing no detectable changes in tacrolimus C0 levels, safety or efficacy, during an average follow-up of six months.
authors.affiliation: The Haemodynamic Lab, The Section for Heart Failure and Valvular Disease, The Clinic for Heart and Lung Disease, Skåne University Hospital, Lund, Sweden.|Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
authors.forename: Carl
authors.initials: C
authors.lastname: Söderlund
authors.affiliation: The Haemodynamic Lab, The Section for Heart Failure and Valvular Disease, The Clinic for Heart and Lung Disease, Skåne University Hospital, Lund, Sweden.|Department of Cardiology, Clinical Sciences, Lund University, Lund, Sweden.
authors.forename: Göran
authors.initials: G
authors.lastname: Rådegran
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D016568:Drugs, Generic / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality; D006085:Graft Survival; D006331:Heart Diseases / Q000150:complications / Q000601:surgery*; D016027:Heart Transplantation; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011183:Postoperative Complications; D011379:Prognosis; D012189:Retrospective Studies; D012307:Risk Factors; D017751:Safety Management; D015996:Survival Rate; D016559:Tacrolimus / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D016568:Drugs, Generic; D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid; D016559:Tacrolimus
keywords: Adoport; Adport; Myfenax Teva; Tacrolimus Sandoz; Transplantation; cardiac; conversion