Generic Substitution of Tacrolimusi De Novo Mexican Renal Transplant Recipients. A Single Center Experience

Tacrolimus is an immunosuppressive agent that has been proven safe and effective for the prevention of graft rejection after organ transplantation. Between 2008 and 2010, the FDA approved several generic formulations of TAC. In Mexico, the first generic TAC product was approved in 2006 and currently...

Full description

Saved in:
Bibliographic Details
Published inBiomedical & pharmacology journal Vol. 8; no. 1; p. 15
Main Authors Robles-Piedras, Ana Luisa, Fuentes-Noriega, Inés, Romano-Moreno, Silvia, Mancilla-Urrea, Eduardo, Domínguez-Ramírez, Adriana Miriam
Format Journal Article
LanguageEnglish
Published Bhopal Biomedical and Pharmacology Journal 01.01.2015
Subjects
Collaboration
Creatinine
Drug dosages
Epidemiology
FDA approval
Generic drugs
Generic products
Graft rejection
Immunosuppressive agents
Kidney diseases
Kidney transplantation
Patients
Pharmaceuticals
Renal function
Studies
Tacrolimus
Transplants & implants
United States > US
Mexico
Online AccessGet full text

Cover

More Information
Summary:Tacrolimus is an immunosuppressive agent that has been proven safe and effective for the prevention of graft rejection after organ transplantation. Between 2008 and 2010, the FDA approved several generic formulations of TAC. In Mexico, the first generic TAC product was approved in 2006 and currently in the domestic pharmaceutical market there are >5 interchangeable generic products. The objective of this study was to compare TAC blood concentrations as well as serum creatinine and creatinine clearance as a measure of renal function found in patients with kidney transplantation with administration of the innovator (Prograf) and the subsequent change to the generic product. The analysis done showed that after the change to generic product, 69% of the patients required a dose adjustment of Tacrolimus ( p <0.05). mean values of serum creatinine exhibited an increase of 3% ( p <0.05). creatinine clearance also showed a decrease after conversion from prograf to the generic product ( p <0.05). the information obtained from patients treated with innovator drugs and generics constitute an important clinic tool, the data obtained is greatly valued, especially on the absence of previous information related to the conversion from prograf to a generic tacrolimus drug in mexican receptors from renal transplants.
ISSN:0974-6242
2456-2610
DOI:10.13005/bpj/576