Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored
Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) re...
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| Format: | Article |
| Language: | English |
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Wiley
2017-01-01
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| Series: | Journal of Transplantation |
| Online Access: | http://dx.doi.org/10.1155/2017/5646858 |
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| author | Fernando González René López Elizabeth Arriagada René Carrasco Natalia Gallardo Eduardo Lorca |
| author_facet | Fernando González René López Elizabeth Arriagada René Carrasco Natalia Gallardo Eduardo Lorca |
| author_sort | Fernando González |
| collection | DOAJ |
| description | Background. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62±0.90 versus 1.75±0.92 mg/dL (p<0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians. |
| format | Article |
| id | doaj-art-b91d0ac6d4de42429c0b55fe07568b7c |
| institution | Kabale University |
| issn | 2090-0007 2090-0015 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Transplantation |
| spelling | doaj-art-b91d0ac6d4de42429c0b55fe07568b7c2025-02-03T01:25:53ZengWileyJournal of Transplantation2090-00072090-00152017-01-01201710.1155/2017/56468585646858Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be MonitoredFernando González0René López1Elizabeth Arriagada2René Carrasco3Natalia Gallardo4Eduardo Lorca5Department of Nephrology, Hospital del Salvador, Santiago de Chile, ChileFaculty of Medicine, Clínica Alemana, Universidad del Desarrollo, Santiago de Chile, ChileFaculty of Medicine, Universidad de Chile, Santiago de Chile, ChileFaculty of Medicine, Universidad de Chile, Santiago de Chile, ChileFaculty of Medicine, Clínica Alemana, Universidad del Desarrollo, Santiago de Chile, ChileDepartment of Nephrology, Hospital del Salvador, Santiago de Chile, ChileBackground. Tacrolimus is the primary immunosuppressive drug used in kidney transplant patients. Replacing brand name products with generics is a controversial issue that we studied after a Chilean Ministry of Health mandate to implement such a switch. Methods. Forty-one stable Prograf (Astellas) receiving kidney transplant patients were switched to a generic tacrolimus (Sandoz) in a 1 : 1 dose ratio and were followed up for up to 8 months. All other drugs were maintained as per normal practice. Results. Neither tacrolimus doses nor their trough blood levels changed significantly after the switch, but serum creatinine did: 1.62±0.90 versus 1.75±0.92 mg/dL (p<0.001). At the same time, five graft biopsies were performed, and two of them showed cellular acute rejection. There were nine infectious episodes treated satisfactorily with proper therapies. No patient or graft was lost during the follow-up time period. Conclusion. Switching from brand name tacrolimus to a generic tacrolimus (Sandoz) is feasible and appears to be safe, but it must be monitored carefully by treating physicians.http://dx.doi.org/10.1155/2017/5646858 |
| spellingShingle | Fernando González René López Elizabeth Arriagada René Carrasco Natalia Gallardo Eduardo Lorca Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored Journal of Transplantation |
| title | Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored |
| title_full | Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored |
| title_fullStr | Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored |
| title_full_unstemmed | Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored |
| title_short | Switching Stable Kidney Transplant Recipients to a Generic Tacrolimus Is Feasible and Safe, but It Must Be Monitored |
| title_sort | switching stable kidney transplant recipients to a generic tacrolimus is feasible and safe but it must be monitored |
| url | http://dx.doi.org/10.1155/2017/5646858 |
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