Generic Substitution of Tacrolimusi De Novo Mexican Renal Transplant Recipients. A Single Center Experience
Robles-Piedras Ana Luisa1,2, Fuentes-Noriega Inés3, Romano-Moreno Silvia4, Mancilla-Urrea Eduardo5, Domínguez-Ramírez Adriana Miriam6

1Doctorado en Ciencias Biológicas y de la Salud, Universidad Autónoma Metropolitana Unidad Xochimilco, Calzada del Hueso 1100, Col. Villa Quietud, Delegación Coyoacán, México, D.F. México. 2Cuerpo Académico de Farmacia Clínica. Área Académica de Farmacia, Instituto de Ciencias de la Salud, Universidad Autónoma del Estado de Hidalgo, Circuito Ex-Hacienda La Concepción, Km. 1.5, San Agustín Tlaxiaca, Hidalgo.  México. C.P. 42160 3Departamento de Farmacia, Facultad de Química, Universidad Nacional Autónoma de México, Conjunto “E”, Laboratorio 113, Paseo de la Investigación Científica s/n , Ciudad Universitaria, Delegación Coyoacán, México, D.F. México. C.P. 04510 4Laboratorio de Biofarmacia y Farmacocinética, Facultad de Ciencias Químicas, Universidad Autónoma de San Luis Potosí, Avenida Dr. Manuel Nava no. 6, Zona Universitaria, San Luis Potosí, SLP. México. C.P.78240 5Departamento de Nefrología,  Instituto Nacional de Cardiología “Ignacio Chávez”, Juan Badiano no. 1, Col. Secc. XVI, Delegación Tlalpan, México, D.F. México. C.P. 14080 6Laboratorio de Farmacocinética, Departamento de Sistemas Biológicos, Universidad Autónoma Metropolitana Unidad Xochimilco, Calzada del Hueso 1100, Col. Villa Quietud, Delegación Coyoacán, México, D.F. México. C.P. 04960.

Abstract: 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.

Keywords: Conversion; Generic; Kidney; Prograf; Tacrolimus; Transplant

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