A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation

Kim, S.J.; Huh, Kyu Ha; Han, Duck Jong; Moon, In-Sung; Kim, Y.-L.; Kim, H.C.; Lee, S.; Kang, Chong Myung; Cho, B.-H.; Kim, Y.S.

doi:10.1016/j.transproceed.2009.03.061

Cited by 22 publications

(15 citation statements)

References 10 publications

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“…This is the second published experience using this drug product in transplant recipients (11). Transplant centers in India (12), South Korea (13,14), and Chile (15) have also reported experience with generic tacrolimus. However, the tacrolimus products used in the Indian and Korean experience do not have FDA approval.…”

Section: Discussionmentioning

confidence: 91%

A Multicenter Experience With Generic Tacrolimus Conversion

Potter

Sadaka²,

Tichy³

et al. 2011

Transplantation

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Section: Discussionmentioning

confidence: 91%

A Multicenter Experience With Generic Tacrolimus Conversion

Potter

Sadaka²,

Tichy³

et al. 2011

Transplantation

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“…Existen diferentes guías de recomendación para el uso de medicamentos genéricos en trasplante 7 ; sin embargo, sigue siendo controversial la bioequivalencia de algunos de estos 2,8,9 . En un estudio realizado en México sobre 3 marcas diferentes de tacrolimús genérico comparado con la sustancia innovadora (Prograf) se encontró que estos no son bioequivalentes al Prograf 9 ; sin embargo, aunque no presenten la misma bioequivalencia, algunos de ellos han demostrado en otros estudios su eficacia y seguridad para su utilización 10 .…”

Section: Figuraunclassified

Rechazo agudo celular por cambio de marca de inmunosupresor genérico en una paciente trasplantada de hígado

Castillo

Rossano-García

Gutiérrez

et al. 2013

Revista de Gastroenterología de México

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“…However, the switch to generic required important dose adjustments in as many as 20% of the patients, mostly to avoid elevated levels that could culminate in potential toxicity. 11 …”

Section: Clinical Experience With Generic Immunosuppressive Drugsmentioning

confidence: 99%

Generic substitution for immunosuppressive drugs

Helderman

2011

Dialysis & Transplantation

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The advent of generic alternatives for transplant immunosuppressant drugs has engendered concern and discussion. The process by which the food and drug administration (FDA) approves generic substitutes is reviewed. A category of medicines deﬁned as narrow therapeutic index (NTI) drugs is deﬁned with evidence that many (but not all) of the commonly used transplant medications fall into this category. It is demonstrated that the current FDA standards are inadequate to vet NTI agents. Outcomes data are presented that show generic switching for NTI drugs can be successfully accomplished with careful blood level monitoring, but clinical and ﬁnancial negative consequences can ﬂow from unregulated switching. Recommendations are made for provider use of generic immunsuppressants, for recipient education and response to switching, and for pharmacy shandling of generic alternatives.

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A 6-Month, Multicenter, Single-Arm Pilot Study to Evaluate the Efficacy and Safety of Generic Tacrolimus (TacroBell) After Primary Renal Transplantation

Cited by 22 publications

References 10 publications

A Multicenter Experience With Generic Tacrolimus Conversion

A Multicenter Experience With Generic Tacrolimus Conversion

Rechazo agudo celular por cambio de marca de inmunosupresor genérico en una paciente trasplantada de hígado

Generic substitution for immunosuppressive drugs

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