Latuda

Latuda

INDICATIONS

Schizophrenia

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].

Depressive Episodes Associated with Bipolar I Disorder

Monotherapy

LATUDA is indicated as monotherapy for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of LATUDA was established in a 6-week monotherapy study in adult patients with bipolar depression [see Clinical Studies].

Adjunctive Therapy with Lithium or Valproate

LATUDA is indicated as adjunctive therapy with either lithium or valproate for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of LATUDA as adjunctive therapy was established in a 6-week study in adult patients with bipolar depression who were treated with lithium or valproate [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].

The efficacy of LATUDA in the treatment of mania associated with bipolar disorder has not been established.

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

Depressive Episodes Associated with Bipolar I Disorder

The recommended starting dose of LATUDA is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. LATUDA has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate [see Clinical Studies]. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) [see Clinical Studies].

Administration Instructions

LATUDA should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of LATUDA. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, LATUDA was administered with food [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 per day. The dose in these patients should not exceed 80 mg per 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 per day. The dose in moderate hepatic impairment patients should not exceed 80 mg per 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 CYP3A4 Inhibitors

LATUDA should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see CONTRAINDICATIONS].

If LATUDA is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the LATUDA dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and LATUDA is added to the therapy, the recommended starting dose of LATUDA is 20 mg per day, and the maximum recommended dose of LATUDA is 80 mg per day [see CONTRAINDICATIONS; DRUG INTERACTIONS].

Grapefruit and grapefruit juice should be avoided in patients taking LATUDA, since these may inhibit CYP3A4 and alter LATUDA concentrations [see DRUG INTERACTIONS].

Concomitant Use with CYP3A4 Inducers

LATUDA should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.) [see CONTRAINDICATIONS; DRUG INTERACTIONS]. If LATUDA is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the LATUDA dose after chronic treatment (7 days or more) with the CYP3A4 inducer.

HOW SUPPLIED

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

Tablet Strength Tablet Color/Shape Tablet Markings
20 mg white to off-white round L20
40 mg white to off-white round L40
60 mg white to off white oblong L60
80 mg pale green oval L80
120 mg white to off-white oval L120

Storage And Handling

LATUDA tablets are white to off-white, round (20 mg or 40 mg), white to off-white, oblong (60 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 26):

Table 26: Package Configuration for LATUDA Tablets

Tablet Strength Package Configuration NDC Code
20 mg Bottles of 30 63402-302-30
Bottles of 90 63402-302-90
Bottles of 500 63402-302-50
Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-302-10 Carton 63402-302-01 Blister
40 mg Bottles of 30 63402-304-30
Bottles of 90 63402-304-90
Bottles of 500 63402-304-50
Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-304-10 Carton 63402-304-01 Blister
60 mg Bottles of 30 63402-306-30
Bottles of 90 63402-306-90
Bottles of 500 63402-306-50
Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-306-10 Carton 63402-306-01 Blister
80 mg Bottles of 30 63402-308-30
Bottles of 90 63402-308-90
Bottles of 500 63402-308-50
Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-308-10 Carton 63402-308-01 Blister
120 mg Bottles of 30 63402-312-30
Bottles of 90 63402-312-90
Bottles of 500 63402-312-50
Box of 100 (Hospital Unit Dose) 10 blister cards, 10 tablets each 63402-312-10 Carton 63402-312-01 Blister

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. Issued: July/2013

Last reviewed on RxList: 7/26/2013
This monograph has been modified to include the generic and brand name in many instances.

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