Lurasidone

Usual Dosing (Adults)

CLINICAL PHARMACOLOGY
Mechanism of Action:
The mechanism of action of lurasidone, as with other drugs having efficacy in schizophrenia, is unknown. It has been suggested that the efficacy of lurasidone in schizophrenia is mediated through a combination of central dopamine Type 2 (D2) and serotonin Type 2 (5HT2A) receptor antagonism.

INDICATIONS AND USAGE
LATUDA is indicated for the treatment of patients with schizophrenia.
The efficacy of LATUDA in schizophrenia was established in four 6-week controlled studies of adult patients with schizophrenia.

The effectiveness of LATUDA for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use LATUDA for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

DOSAGE AND ADMINISTRATION
Schizophrenia:
The recommended starting dose of LATUDA is 40 mg once daily. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 40 mg/day to 120 mg/day. In the 6-week controlled trials, there was no suggestion of added benefit with the 120 mg/day dose, but there was a dose-related increase in certain adverse reactions. Therefore, the maximum recommended dose is 80 mg/day.

Administration Instructions: LATUDA should be taken with food (at least 350 calories)

Renal Dosing

Dosage in Special Populations:
Renal Impairment:
It is recommended that LATUDA dose should not exceed 40 mg/day in patients with moderate and severe renal impairment (Clcr ≥ 10 mL/min to < 50 mL/min).

After administration of a single dose of 40 mg LATUDA to patients with mild, moderate and severe renal impairment, mean Cmax increased by 40%, 92% and 54%, respectively and mean AUC increased by 53%, 91% and 2- times, respectively compared to healthy matched subjects.

Dose adjustment is recommended in moderate and severe hepatic impairment patients. The dose in these patients should not exceed 40 mg/day.

Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inhibitors: When coadministration of LATUDA with a moderate CYP3A4 inhibitor such as diltiazem is considered, the dose should not exceed 40 mg/day. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole).

Dosing recommendation for patients taking LATUDA concomitantly with potential CYP3A4 inducers: LATUDA should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin).

Hemodialysis

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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