Patent ID: 9168246
Filing Date: 2015-10-27
Classification: A61K,A61P

Abstract:
1. A method of suppressing organ rejection in a de novo kidney transplant recipient, the method comprising: (a) initiating oral treatment with a once-daily extended release tacrolimus dosage form at an initial dose of from about 0.17 mg/kg/day following transplantation, (b) concomitantly treating the recipient with mycophenolate mofetil, and (c) adjusting the dose of the extended release tacrolimus dosage form so that the whole blood pre-dose (trough) concentration of tacrolimus is maintained in the range of from about 8.8 to about 9.3 ng/mL from day 2 to week 3 of tacrolimus treatment, and from about 6.5 to about 8.8 ng/mL for month 1 to 12, wherein (i) the once-daily extended release tacrolimus dosage form provides a fluctuation of less than 80% and a swing less than 120%; and (ii) the once-daily extended release tacrolimus dosage form releases the tacrolimus substantially in the colon, the lower ileum, or both the colon and lower ileum.