Regimen for suppressing organ rejection
AssigneeVeloxis Pharmaceutical A/S
InventorWilliam J. Polvino
Life of this patent
Estimating the term…
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.
Claims11
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.
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,
- 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 at least 50% of the tacrolimus in the colon, the lower ileum, or both the colon and lower ileum.
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 6.5 to about 8.8 ng/mL from the end of month 1 to the end of month 12 of tacrolimus treatment,
- 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.
Dependencies are inferred from the claim text.