LATUDA is indicated for the treatment of patients with schizophrenia.

The efficacy of LATUDA in schizophrenia was established in five 6-week controlled studies of adult patients with schizophrenia [see Clinical Studies].

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 [see 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 160 mg/day [see Clinical Studies]. The maximum recommended dose is 160 mg/day.

Administration Instructions

LATUDA should be taken with food (at least 350 calories) [see CLINICAL PHARMACOLOGY].

Dose Modifications in Special Populations

Renal Impairment

Dose adjustment is recommended in moderate (creatinine clearance: 30 to < 50 mL/min) and severe renal impairment (creatinine clearance < 30 mL/min) patients. The recommended starting dose is 20 mg. The dose in these patients should not exceed 80 mg/day [see Use in Specific Populations].

Hepatic Impairment

Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. The recommended starting dose is 20 mg. The dose in moderate hepatic impairment patients should not exceed 80 mg/day and the dose in severe hepatic impairment patients should not exceed 40 mg/day [see Use in Specific Populations].

Dose Modifications Due to Drug Interactions

Concomitant Use with Potential CYP3A4 Inhibitors

The recommended starting dose is 20 mg/day. The dose of LATUDA should not exceed 80 mg/day in combination with a moderate CYP3A4 inhibitor such as diltiazem. LATUDA should not be used in combination with a strong CYP3A4 inhibitor (e.g., ketoconazole) [see CONTRAINDICATIONS; DRUG INTERACTIONS].

Concomitant Use with Potential CYP3A4 Inducers

LATUDA should not be used in combination with a strong CYP3A4 inducer (e.g., rifampin) [see CONTRAINDICATIONS; DRUG INTERACTIONS].

Dosage Forms And Strengths

LATUDA tablets are available in the following shape and color (Table 1) with respective one-sided debossing:

Table 1: LATUDA Tablet Presentations

Storage And Handling

LATUDA tablets are white to off-white, round (20 mg or 40 mg), pale green, oval (80 mg) or white to off-white, oval (120 mg) and identified with strength-specific one-sided debossing, “L20” (20 mg), “L40” (40 mg), “L80” (80 mg) or “L120” (120 mg). Tablets are supplied in the following strengths and package configurations (Table 9):

Table 9: Package Configuration for LATUDA Tablets

Storage

Store LATUDA tablets at 25°C (77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature].

Manufactured for: Sunovion Pharmaceuticals Inc. Marlborough, MA 01752 USA. Revised: December 2012

Last reviewed on RxList: 2/4/2013
This monograph has been modified to include the generic and brand name in many instances.