Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients. (16th June 2015)

• Record Type: Journal Article
• Authors: Söderlund, Carl; Rådegran, Göran
• Is Part Of: Clinical transplantation. Volume 29:Number 7(2015)
• Page Start: 619
• Page End: 628
• Publication Date: 2015-06-16
• Subjects: Adoport -- Adport -- cardiac -- conversion -- Myfenax Teva -- Tacrolimus Sandoz -- Transplantation; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ctr.12564
• Languages: English
• ISSNs: 0902-0063

Abstract

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. Conclusion: 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.