Regimen for suppressing organ rejection
AssigneeVeloxis Pharmaceuticals, Inc.
InventorWilliam J. Polvino
Life of this patent
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Abstract
The present invention relates to a method of suppressing organ rejection in a patient receiving an organ transplant by initiating oral treatment with a once-daily extended release tacrolimus dosage form, for example, at an initial dose of from about 0.15 to about 0.20 mg/kg/day within 24 or 48 hours following transplantation. The once-daily extended release tacrolimus dosage form (i) provides low fluctuation and/or swing of tacrolimus, (ii) provides a significantly lower Cmax than an immediate release formulation of tacrolimus while providing the same or greater area under the curve (AUC), (iii) releases the tacrolimus substantially in the colon and/or the lower ileum, (iv) releases at most 63.5% of the tacrolimus in the dosage form at the 12 hour time point, or (v) any combination of any of the foregoing.
Claims20
A method of suppressing organ rejection in a de novo African-American transplant patient comprising initiating oral treatment with a once-daily extended release tacrolimus dosage form at an initial dose of from about 0.15 to about 0.20 mg/kg/day following transplantation, wherein (i) the once-daily extended release tacrolimus dosage form provides a fluctuation of less than 100%, a swing less than 120%, or both, and (ii) the extended release dosage form releases at least 50% of the tacrolimus in the colon and/or the lower ileum.
A method of suppressing organ rejection in a de novo African-American organ 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 0.15 to about 0.20 mg/kg/day following transplantation, wherein
- (i) the once-daily extended release tacrolimus formulation provides a fluctuation of less than 100%, a swing less than 120% or both;
- and
- (ii) the once-daily extended release tacrolimus formulation releases the tacrolimus substantially in the colon and/or the lower ileum;
- and
- (b) concomitantly treating the recipient with an IL-2 receptor antagonist and mycophenolate mofetil.
Dependencies are inferred from the claim text.