Dosage regimen of an s1p receptor modulator
AssigneeNovartis AG
InventorsCraig Boulton, Pascale Burtin, Olivier David, Ana de Vera, Thomas Dumortier, Irene Hunt, Robert Schmouder
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Abstract
S1P receptor modulators are administered following a dosage regimen providing a positive benefit-risk profile.
Claims34
A method for treating an inflammatory or autoimmune disease or disorder in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of a S1P receptor modulator or agonist, in such as way that the adverse events possibly associated with administering said S1P receptor modulator or agonist are controlled, limited, reduced or abolished, wherein said method comprises the steps of
- i) monitoring the patient during a specific period of time after the first administration of said S1P receptor modulator or agonist,
- wherein said patient monitoring comprises one or more steps of
- a) monitoring infections or infestations, e.g. viral infections, throughout administering said S1P receptor modulator or agonist,
- b) performing an ophthalmologic examination,
- ii) optionally interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof.
A method of controlling, reducing, or abolishing the possible adverse events associated with treating a patient suffering from an inflammatory or autoimmune disease or disorder with a S1P receptor modulator or agonist, comprising administering to said patient a therapeutically effective amount of said S1P receptor modulator or agonist, wherein said method comprises one or more steps of
- a) monitoring infections or infestations, e.g. viral infections, and
- b) performing an ophthalmologic examination,
- ii) optionally interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof.
A method for treating an inflammatory or autoimmune disease or disorder in a patient in need thereof, comprising administering to said patient a therapeutically effective amount of S1P receptor modulator or agonist in such as way that the adverse events possibly associated with said S1P receptor modulator or agonist are controlled, limited, reduced or abolished, wherein said method comprises i) checking specific parameters of the patient before initiating and/or during administration of said S1P receptor modulator or agonist, wherein said parameters comprise one or more of
- a) signs of infections or infestations, e.g. viral infections,
- b) visual acuity
- c) liver enzymes
- d) blood pressure
- and ii) as necessary, interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof.
A method of controlling, reducing, limiting or abolishing the possible adverse events associated with a treatment of a patient suffering from an inflammatory or autoimmune disease or disorder, wherein said treatment comprises administering a daily dosage of a drug selected from fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof, not exceeding about 0.5 mg to the patient, such a method comprising monitoring the patient during a specific period of time after the first administration of said drug, and if necessary either interrupting the administration of said drug, either modifying the treatment regimen thereof and/or administering a second drug which mitigates said possible adverse events,
- wherein said monitoring comprises one or more steps of
- a) monitoring infections or infestations, e.g. viral infections, throughout drug administration, and
- b) performing an ophthalmologic examination after starting administration.
A method for treating multiple sclerosis comprising
- (a) administering a varied dose of a drug selected from the group consisting of fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof in a patient in need thereof,
- (b) monitoring adverse events occurring in said patient,
- (c) monitoring reduction or abolition of symptoms associated with multiple sclerosis, and
- (d) determining optimal dose for said patient,
- wherein the daily dose of the drug does not exceed 0.5 mg.
A method for treating multiple sclerosis comprising
- (a) administering a varied dose of a drug selected from the group consisting of fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof in a patient in need thereof,
- (b) monitoring adverse events occurring in said patient,
- (c) monitoring reduction or abolition of symptoms associated with multiple sclerosis, and
- (d) determining optimal dose for said patient,
- wherein the daily dosage of the drug exceeds 0.5 mg, e.g. is about 1.25 mg.
A method for determining a personalized therapeutic treatment regimen of a drug selected from the group consisting of fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof, in a patient suffering from an inflammatory or autoimmune disease, wherein said method comprises
- (a) administering a varied dose of said drug to the patient,
- (b) monitoring adverse events occurring in said patient,
- (c) monitoring reduction or abolition of symptoms associated with multiple sclerosis, and
- (d) determining optimal dose for said patient,
- wherein said regimen is adapted for treating said disease or disorder and controlling, reducing, or abolishing the possible adverse events associated with administering said S1P receptor modulator or agonist.
A method for treating an inflammatory or autoimmune disease in a patient in need thereof and further suffering from bradyarrhytmia or at risk thereof, said method comprising administering a therapeutically effective amount of a S1P receptor modulator or agonist, and comprising the steps of
- i) monitoring the patient during a specific period of time after the first administration of said S1P receptor modulator or agonist, and
- ii) optionally interrupting the administration of said S1P receptor modulator or agonist and/or modifying the treatment regimen thereof,
- wherein said patient monitoring comprises the steps of
- a) monitoring infections or infestations, e.g. viral infections, throughout administering said S1P receptor modulator or agonist,
- b) performing an ophthalmologic examination,
- c) monitoring the heart rate of the patient at least during the first hours after the first administration of said S1P receptor modulator or agonist, e.g. the 1 to 10 hours after the first administration of said S1P receptor modulator or agonist, and optionally
- d) observing the patient for the 1 to 10 hours after the first administration of said S1P receptor modulator or agonist to monitor the heart rate of the patient, e.g. during the first 6 hours.
A combination containing a first drug which is selected from the group consisting of fingolimod (FTY720), a phosphate derivative thereof and a pharmaceutically acceptable salt thereof, and a second drug which is selected from the group consisting of drugs which treat or prevent macular edema, anti-cancer agent, anti infection agents and anti-hypertensive drugs, whereby the daily dosage of the first drug is not exceeding about 0.5 mg.
A kit containing daily units of medication of a first drug which is selected from the group consisting of fingolimod (FTY720), a phosphate derivative thereof or a pharmaceutically acceptable salt thereof, and a second drug which is selected from the group consisting of anti-cancer agent, anti-infection agents and anti-hypertensive drugs, whereby the daily dosage of the first drug is above 0.5 mg.
Dependencies are inferred from the claim text.