Dosage Regimen of an S1P Receptor Agonist
AssigneeNovartis AG
InventorsJohn M. Kovarik, Silke Appel-Dingemanse
Life of this patent
Estimating the term…
Abstract
S1P receptor modulators or agonists are administered following a dosage regimen whereby during the initial 3 to 6 days of treatment the daily dosage is raised so that in total the R-fold (R being the accumulation factor) standard daily dosage is administered and thereafter continued at the standard daily dosage or at a daily dosage lower than the standard daily dosage.
Claims19
A method for treating an inflammatory or autoimmune disease or disorder in a subject in need thereof, comprising administering to the subject a S1P receptor modulator or agonist in such a pharmaceutically effective amount that a steady-state of the S1P receptor modulator or agonist blood levels is attained in the subject in less than a week, wherein the daily dosage of said S1P receptor modulator or agonist during the initial three to six days of treatment is increased stepwise up to a dosage that is 3- to 21-fold relative to the standard daily dosage of said S1P receptor modulator or agonist, wherein such a regimen is administered at the beginning of an autoimmune disease therapy or after an interruption of S1P receptor modulator or agonist therapy, and wherein the standard daily dosage is the dosage necessary for a stable blood level concentration of the medication providing effective treatment.
A method for treating an inflammatory or autoimmune disease or disorder in a subject in need thereof, comprising administering to the subject an S1P receptor modulator or agonist in such a pharmaceutically effective amount that a steady-state of the S1P receptor modulator or agonist blood levels is attained in less than a week, and thereafter continuing the treatment at a dosage lower than the standard daily dosage, wherein the daily dosage of said S1P receptor modulator or agonist during the initial three to six days of treatment is increased stepwise up to a dosage that is 3- to 21-fold relative to the standard daily dosage of said S1P receptor modulator or agonist.
A method for treating an inflammatory or autoimmune disease in a subject in need thereof, comprising administering to the subject, after a loading regimen, a S1P receptor modulator or agonist at a daily dosage which is lower than the standard daily dosage, wherein the loading regimen is administered during the initial three to six days in a dosage that is increased stepwise up to a dosage that is 3- to 21-fold relative to the standard daily dosage of said S1P receptor modulator or agonist.
A kit containing daily units of medication of an S1P receptor modulator or agonist of varying daily dosage, whereby the daily dosage of said S1P receptor modulator or agonist for the initial three to six days of treatment is incrementally increased so that the total amount present in the daily units corresponds to the R-fold standard daily dosage of said S1P receptor modulator or agonist for this initial time period.
A kit containing daily units of medication of an S1P receptor modulator or agonist of varying daily dosage, whereby the daily dosage of S1P receptor modulator or agonist for the initial four days of treatment is ¼;
- ½;
- and ¾ of the highest installment dose of the S1P receptor modulator or agonist;
- and four times the maintenance dose of the S1P receptor modulator or agonist, respectively.
A kit comprising daily units of medication, wherein said medication is an S1P receptor modulator or agonist, and wherein the daily dosages of said medication vary, and wherein the daily dosages of said S1P receptor modulator or agonist for the initial four days of treatment are, respectively, 1-fold, 1.5 to 2-fold;
- 2 to 3-fold and 3 to 4-fold relative to the standard daily dosage of the S1P receptor modulator or agonist.
Dependencies are inferred from the claim text.