Label: LATUDA- lurasidone hydrochloride tablet, film coated

  • NDC Code(s): 63402-302-01, 63402-302-04, 63402-302-07, 63402-302-10, view more
  • Packager: Sumitomo Pharma America, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 31, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use LATUDA safely and effectively. See full prescribing information for LATUDA. LATUDA (lurasidone hydrochloride) tablets, for oral ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)
    Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death ...

    WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS

    Increased Mortality in Elderly Patients with Dementia-Related Psychosis

    Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)].

    Suicidal Thoughts and Behaviors

    Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2)].

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  • 1 INDICATIONS AND USAGE
    LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies (14.1)]. Monotherapy treatment of adult and pediatric patients (10 ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Schizophrenia - Adults - 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 ...
  • 3 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 StrengthTablet Color/ShapeTablet ...
  • 4 CONTRAINDICATIONS
    Known hypersensitivity to lurasidone HCl or any components in the formulation. Angioedema has been observed with lurasidone [see Adverse Reactions (6.1)]. Strong CYP3A4 inhibitors (e.g. ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death ...
  • 6 ADVERSE REACTIONS
    The following adverse reactions are discussed in more detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning and ...
  • 7 DRUG INTERACTIONS
    7.1 Drugs Having Clinically Important Interactions with LATUDA - Table 34: Clinically Important Drug Interactions with LATUDA - Strong CYP3A4 Inhibitors - Clinical Impact: Concomitant use ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Pregnancy Exposure Registry - There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to LATUDA during pregnancy. For more information ...
  • 9 DRUG ABUSE AND DEPENDENCE
    9.1 Controlled Substance - LATUDA is not a controlled substance. 9.2 Abuse - LATUDA has not been systematically studied in humans for its potential for abuse or physical dependence or its ...
  • 10 OVERDOSAGE
    10.1 Human Experience - In premarketing clinical studies, accidental or intentional overdosage of LATUDA was identified in one patient who ingested an estimated 560 mg of LATUDA. This patient ...
  • 11 DESCRIPTION
    LATUDA is an atypical antipsychotic belonging to the chemical class of benzisothiazol derivatives. Its chemical name is ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis: Lurasidone increased incidences of malignant mammary gland tumors and pituitary gland adenomas in female mice ...
  • 14 CLINICAL STUDIES
    14.1 Schizophrenia - Adults - The efficacy of LATUDA for the treatment of schizophrenia was established in five short-term (6-week), placebo-controlled studies in adult patients (mean age of ...
  • 16 HOW SUPPLIED/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 ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Suicidal Thoughts and Behavior - Advise patients and caregivers to look for the emergence of suicidality ...
  • MEDICATION GUIDE
    This Medication Guide has been approved by the U.S. Food and Drug Administration . Revised: 1/2025 - MEDICATION GUIDE - LATUDA (luh-TOO-duh) (lurasidone ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 20 mg, 30 Tablet Label - NDC 63402-302-30 - 30 Tablets - Latuda® (lurasidone HCl) tablets - 20 mg - ATTENTION DISPENSER: Each time Latuda - is dispensed give ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 40 mg, 30 Tablet Label - NDC 63402-304-30 - 30 Tablets - Latuda® (lurasidone HCl) tablets - 40 mg - ATTENTION DISPENSER: Each time Latuda - is dispensed give ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 mg, 30 Tablet Label - NDC 63402-306-30 - 30 Tablets - Latuda® (lurasidone HCl) tablets - 60 mg - ATTENTION DISPENSER: Each time Latuda - is dispensed give ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 mg, 90-ct LABEL - NDC 63402-306-90 - 90 Tablets - Latuda® (lurasidone HCl) tablets - 60 mg - ATTENTION DISPENSER: Each time Latuda is dispensed give the ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 mg, 500-ct LABEL - NDC 63402-306-50 - 500 Tablets - Latuda® (lurasidone HCl) tablets - 60 mg - ATTENTION DISPENSER: Each time Latuda is dispensed give the ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 mg Blister - NDC 63402-306-07 - 7 Tablets - PROFESSIONAL SAMPLE - NOT FOR SALE OR REIMBURSEMENT - Latuda® (lurasidone HCl) tablets - 60 mg per tablet - Rx ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – 60 mg Carton - NDC 63402-306-70 - 28 Tablets (4 Cards, 7 Tablets Each) PROFESSIONAL SAMPLE - NOT FOR SALE OR REIMBURSEMENT - Latuda® (lurasidone HCl ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL – 60 mg Blister - NDC 63402-306-01 - 10 Tablets - Latuda® (lurasidone HCl) tablets - 60 mg - EXP: LOT: Sunovion Pharmaceuticals Inc.
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 60 mg, HUD Carton - NDC 63402-306-10 - 100 Tablets (10 Cards, 10 Tablets Each) Latuda® (lurasidone HCl) tablets - 60 mg per tablet - ATTENTION DISPENSER ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 80 mg, 30 Tablet Label - NDC 63402-308-30 - 30 Tablets - Latuda® (lurasidone HCl) tablets - 80 mg - ATTENTION DISPENSER: Each time Latuda - is dispensed give ...
  • PRINCIPAL DISPLAY PANEL
    PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - 120 mg, 30 Tablet Label - NDC 63402-312-30 - 30 Tablets - Latuda® (lurasidone HCl) tablets - 120 mg - ATTENTION DISPENSER: Each time Latuda - is dispensed ...
  • INGREDIENTS AND APPEARANCE
    Product Information