Dosing regimen for missed doses for long-acting injectable paliperidone esters
AssigneeJanssen Pharmaceuticals, Inc.
InventorsSrihari Gopal, Paulien Gerarda Maria Ravenstijn, Alberto Russu, Mahesh Narain Samtani
Life of this patent
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Abstract
The present application provides a method for treating patients in need of psychiatric treatment, wherein said patient is being treated with the 3-month formulation of paliperidone palmitate and fails to take the next scheduled dose of the 3-month formulation of paliperidone palmitate.
Claims8
A dosing regimen for administering an injectable paliperidone palmitate depot to a patient in need of psychiatric treatment that has been treated with a 3-month injectable paliperidone palmitate depot, wherein said patient misses for a period of nine months or longer the next scheduled maintenance dose of the 3-month injectable paliperidone palmitate depot, comprising:
- (1) administering intramuscularly in the deltoid muscle of said patient a first reinitiation loading dose of 150 mg eq. of the monthly injectable paliperidone palmitate depot;
- (2) administering intramuscularly in the deltoid muscle of said patient a second reinitiation loading dose of 100 mg eq. the monthly injectable paliperidone palmitate depot on about the 4th day to about the 12th day after administering of said first reinitiation loading dose;
- (3) administering intramuscularly in the deltoid or gluteal muscle of said patient a first reinitiation maintenance dose of 50 mg eq. to about 150 mg eq. of the monthly injectable paliperidone palmitate depot on about the 23th day to about the 37rd day after administering of said second reinitiation loading dose;
- (4) administering intramuscularly in the deltoid or gluteal muscle of said patient a second reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of monthly injectable paliperidone palmitate depot on about the 23rd day to about the 37th day after administering of the first maintenance additional dose;
- (5) administering intramuscularly in the deltoid or gluteal muscle of said patient a third reinitiation maintenance dose of from about 50 mg eq. to about 150 mg eq. of monthly injectable paliperidone palmitate depot on about the 23rd day to about the 37th day after administering of the second maintenance dose;
- and
- (6) administering intramuscularly in the deltoid or gluteal muscle of said patient from about 175 mg eq. to about 525 mg eq. of the 3-month formulation of paliperidone palmitate on about the 23rd day to about the 37th day after administering of the third maintenance dose of monthly injectable paliperidone palmitate.
A dosing regimen for administering an injectable paliperidone palmitate depot to a patient in need of psychiatric treatment that has been treated with a 3-month injectable paliperidone palmitate depot, wherein said patient misses for a period of more than or equal to four months and up to nine months the next scheduled maintenance dose of the 3-month injectable paliperidone palmitate depot, comprising:
- (1) administering intramuscularly in the deltoid muscle of said patient a first reinitiation loading dose the monthly injectable paliperidone palmitate depot;
- (2) administering intramuscularly in the deltoid or gluteal muscle of said patient a second reinitiation loading dose of the monthly injectable paliperidone palmitate depot on about the 4th day to about the 12th day after administering of said first reinitiation loading dose;
- and
- (3) administer intramuscularly in the deltoid or gluteal muscle of said patient the reinitiation 3-month formulation of paliperidone palmitate in the range of about 175 mg eq. to about 525 mg eq. on about the 23rd day to about the 37th day after administering the second reinitiation loading dose of monthly injectable paliperidone palmitate
- wherein said first and second reinitiation loading dose the reinitiation 3-month formulation of paliperidone palmitate dose are selected from the table below based on the amount of the missed dose
- Administer PP1M,
- Then administer
- two doses one week
- PP3M (into deltoida
- Missed
- apart (into deltoid muscle)
- or gluteal muscle)
- Dose
- Day 1
- Day 8
- 1 month after day 8
- 175 mg eq.
- 50 mg eq.
- 50 mg eq.
- 175 mg eq.
- 263 mg eq.
- 75 mg eq.
- 75 mg eq.
- 263 mg eq.
- 350 mg eq.
- 100 mg eq.
- 100 mg eq.
- 350 mg eq.
- 525 mg eq.
- 100 mg eq.
- 100 mg eq.
- 525 mg eq.
Dependencies are inferred from the claim text.