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The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function.
Am J Transplant. 2011 Sep; 11(9):1861-7.AJ

Abstract

Bioequivalence of the recently available generic tacrolimus formulation, manufactured by Sandoz, to the reference product (Prograf; Astellas Pharma, Tokyo, Japan) has been demonstrated in healthy subjects. However, the safety and efficacy of substitution with generic tacrolimus in transplant patients have not been evaluated. Tacrolimus trough concentrations and indices of liver and kidney function were recorded before and after generic substitution in 48 liver and 55 kidney transplant recipients. In liver transplant patients, the mean tacrolimus concentration/dose (C/D) ratio (± SD) was 184.1 (± 123.2) ([ng/mL]/[mg/kg/day]) for the reference product and 154.7 (± 87.8) ([ng/mL]/[mg/kg/day]) for the generic product (p < 0.05). The mean C/D-ratios in kidney transplant patients were 125.3 (± 92.7) and 110.4 (± 79.2) ([ng/mL]/[mg/kg/day]) for the reference and generic products, respectively (p < 0.05). Actual trough concentrations declined by an average of 1.98 ng/mL in liver and 0.87 ng/mL in kidney transplant patients following the switch, after accounting for all significant covariates. No change was observed in biochemical indices of liver or kidney function and no cases of acute rejection occurred following the substitution. These results suggest that transplant patients currently taking the reference tacrolimus formulation may be safely switched to the Sandoz-generic product provided trough concentrations are closely monitored following the substitution.

Authors+Show Affiliations

Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

21714845

Citation

Momper, J D., et al. "The Impact of Conversion From Prograf to Generic Tacrolimus in Liver and Kidney Transplant Recipients With Stable Graft Function." American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, vol. 11, no. 9, 2011, pp. 1861-7.
Momper JD, Ridenour TA, Schonder KS, et al. The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. Am J Transplant. 2011;11(9):1861-7.
Momper, J. D., Ridenour, T. A., Schonder, K. S., Shapiro, R., Humar, A., & Venkataramanan, R. (2011). The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 11(9), 1861-7. https://doi.org/10.1111/j.1600-6143.2011.03615.x
Momper JD, et al. The Impact of Conversion From Prograf to Generic Tacrolimus in Liver and Kidney Transplant Recipients With Stable Graft Function. Am J Transplant. 2011;11(9):1861-7. PubMed PMID: 21714845.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The impact of conversion from prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. AU - Momper,J D, AU - Ridenour,T A, AU - Schonder,K S, AU - Shapiro,R, AU - Humar,A, AU - Venkataramanan,R, Y1 - 2011/06/30/ PY - 2011/7/1/entrez PY - 2011/7/1/pubmed PY - 2011/12/23/medline SP - 1861 EP - 7 JF - American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons JO - Am. J. Transplant. VL - 11 IS - 9 N2 - Bioequivalence of the recently available generic tacrolimus formulation, manufactured by Sandoz, to the reference product (Prograf; Astellas Pharma, Tokyo, Japan) has been demonstrated in healthy subjects. However, the safety and efficacy of substitution with generic tacrolimus in transplant patients have not been evaluated. Tacrolimus trough concentrations and indices of liver and kidney function were recorded before and after generic substitution in 48 liver and 55 kidney transplant recipients. In liver transplant patients, the mean tacrolimus concentration/dose (C/D) ratio (± SD) was 184.1 (± 123.2) ([ng/mL]/[mg/kg/day]) for the reference product and 154.7 (± 87.8) ([ng/mL]/[mg/kg/day]) for the generic product (p < 0.05). The mean C/D-ratios in kidney transplant patients were 125.3 (± 92.7) and 110.4 (± 79.2) ([ng/mL]/[mg/kg/day]) for the reference and generic products, respectively (p < 0.05). Actual trough concentrations declined by an average of 1.98 ng/mL in liver and 0.87 ng/mL in kidney transplant patients following the switch, after accounting for all significant covariates. No change was observed in biochemical indices of liver or kidney function and no cases of acute rejection occurred following the substitution. These results suggest that transplant patients currently taking the reference tacrolimus formulation may be safely switched to the Sandoz-generic product provided trough concentrations are closely monitored following the substitution. SN - 1600-6143 UR - https://www.unboundmedicine.com/medline/citation/21714845/full_citation/The_Impact_of_Conversion_From_Prograf_to_Generic_Tacrolimus_in_Liver_and_Kidney_Transplant_Recipients_With_Stable_Graft_Function_ L2 - https://doi.org/10.1111/j.1600-6143.2011.03615.x DB - PRIME DP - Unbound Medicine ER -