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Generic Tacrolimus Safe for Liver, Kidney Recipients

No change in liver, kidney function; no rejection seen after substitution for reference product

MONDAY, Sept. 26 (HealthDay News) -- Patients who have undergone liver or kidney transplants may safely switch from brand-name to generic tacrolimus with no change in the indices of liver or kidney function or rejection, according to a study published in the September issue of the American Journal of Transplantation.

Jeremiah D. Momper, Pharm.D., from the University of Pittsburgh, and colleagues evaluated the safety and efficacy of substituting generic tacrolimus (manufactured by Sandoz) with the reference product Prograf in liver or kidney transplant patients. Indices of liver and kidney function as well as tacrolimus trough concentrations were measured in 48 liver transplant patients and 55 kidney transplant patients before and after generic substitution.

The investigators found that the mean tacrolimus concentration/dose ratio was 184.1 ng/mL/mg/kg/day for the reference product and 154.7 ng/mL/mg/kg/day for generic tacrolimus for liver transplant patients. For kidney transplant patients, the ratios were 125.3 ng/mL/mg/kg/day for the reference product and 110.4 ng/mL/mg/kg/day for the generic product. Following substitution, the actual decrease in trough concentrations was an average of 1.98 ng/mL and 0.87 ng/mL in liver and kidney transplant patients, respectively, after adjusting for all covariates. No change in biochemical indices of liver and kidney function and no cases of acute rejection after substitution were found.

"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," the authors write.

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