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What Lurasidone is approved for (FDA label)

Lurasidone hydrochloride tablets are indicated for: • Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )]. • Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression) [see Clinical Studies ( 14.2 )]. Lurasidone hydrochloride tablets are an atypical antipsychotic indicated for the treatment of: • Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults and pediatric patients (10 to 17 years) as monotherapy ( 1 , 14.2 ) • Depressive episode associated with Bipolar I Disorder (bipolar depression) in adults as adjunctive therapy with lithium or valproate ( 1, 14.2 )

Source: Read the full FDA label on DailyMed. Label effective date: September 1, 2026.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Lurasidone (FDA label)

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. Lurasidone hydrochloride tablets are 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) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone hydrochloride tablets are not approved for the treatment of patients with dementia-related psychosis ( 5.1 ). • Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adult patients. Closely monitor for clinical worsening and emergence of suicidal thoughts and behaviors. ( 5.2 ).

Source: FDA prescribing information (DailyMed). Set ID: 6008ccac-948e-4b6a-a288-7dd245c2bac4. SPL document ID: 5a71017a-dd08-b810-e063-6294a90a3f14. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Lurasidone (FDA label)

Lurasidone hydrochloride tablets are available in the following shape and color (Table 1) with respective two sided debossing. Table 1: Lurasidone Hydrochloride Tablet Presentations T ablet Strength T ablet Color/Shape T ablet Markings 20 mg white to off-white round “20” on one side and “L” on other side 40 mg white to off-white round “40” on one side and “L” on other side 60 mg white to off-white capsule “60" on one side and “L” on other side 80 mg Light-green to green oval “80” on one side and “L” on other side 120 mg white to off-white oval “120” on one side and “L” on other side Tablets: 20 mg (3 )

Source: FDA prescribing information (DailyMed). Set ID: 6008ccac-948e-4b6a-a288-7dd245c2bac4. SPL document ID: 5a71017a-dd08-b810-e063-6294a90a3f14. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Lurasidone (FDA label)

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 Warnings and Precautions (5.1 )] • Suicidal Thoughts and Behaviors [see Boxed Warning and Warnings and Precautions (5.2) ] • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis [see Warnings and Precautions (5.3 )] • Neuroleptic Malignant Syndrome [see Warnings and Precautions (5.4) ] • Tardive Dyskinesia [see Warnings and Precautions (5.5 )] • Metabolic Changes [see Warnings and Precautions (5.6)] • Hyperprolactinemia [see Warnings and Precautions (5.7)] • Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.8)] • Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.9)] • Falls [see Warnings and Precautions ( 5.10 )] • Seizures [see Warnings and Precautions (5.11) ] • Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.12 )] • Body Temperature Dysregulation [see Warnings and Precautions (5.13) ] • Activation of Mania/Hypomania [see Warnings and Precautions (5.14)] • Dysphagia [see Warnings and Precautions (5.15) ] • Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies [see Warnings and Precautions (5.16 )] Commonly observed adverse reactions (incidence ≥ 5% and at least twice the rate for placebo) were (6.1) : • Adult patients with bipolar depression: akathisia, extrapyramidal symptoms, and somnolence • Pediatric patients (10-17 years) with bipolar depression: nausea, weight increase, and insomnia.

Source: FDA prescribing information (DailyMed). Set ID: 6008ccac-948e-4b6a-a288-7dd245c2bac4. SPL document ID: 5a71017a-dd08-b810-e063-6294a90a3f14. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Lurasidone (FDA label)

• 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., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions (7.1) ]. • Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine, etc.) [see Drug Interactions (7.1) ]. • Known hypersensitivity to lurasidone hydrochloride tablets or any components in the formulation (4). • Concomitant use with a strong CYP3A4 inhibitor (e.g., ketoconazole) ( 2.6 , 4, 7.1 ). • Concomitant use with a strong CYP3A4 inducer (e.g., rifampin) ( 2.6 , 4, 7.1 ).

Source: FDA prescribing information (DailyMed). Set ID: 6008ccac-948e-4b6a-a288-7dd245c2bac4. SPL document ID: 5a71017a-dd08-b810-e063-6294a90a3f14. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Lurasidone (FDA label)

• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia- Related Psychosis: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) ( 5.3 ). • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4 ). • Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5 ). • Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia and weight gain ( 5.6 ). • Hyperprolactinemia: Prolactin elevations may occur ( 5.7 ). • Leukopenia, Neutropenia, and Agranulocytosis : Perform complete blood counts (CBC) in patients with a pre-existing low white blood cell count (WBC) or a history of leukopenia or neutropenia. Consider discontinuing lurasidone hydrochloride tablets if a clinically significant decline in WBC occurs in the absence of other causative factors ( 5.8 ).

Source: FDA prescribing information (DailyMed). Set ID: 6008ccac-948e-4b6a-a288-7dd245c2bac4. SPL document ID: 5a71017a-dd08-b810-e063-6294a90a3f14. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Lurasidone (FDA label)

7.1 Drugs Having Clinically Important Interactions with lurasidone hydrochloride tablets Table 34: Clinically Important Drug Interactions with lurasidone hydrochloride tablets Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride tablets with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride tablets alone [ see Clinical Pharmacology (12.3) ]. Intervention: Lurasidone hydrochloride tablets should not be used concomitantly with strong CYP3A4 inhibitors [ see Contraindications (4) ]. Examples: Ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil Moderate CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride tablets with moderate CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride tablets alone [ see Clinical Pharmacology (12.3) ]. Intervention: Lurasidone hydrochloride tablets dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 [ see Dosage and Administration (2.6) ]. Examples: Diltiazem, atazanavir, erythromycin, fluconazole, verapamil Strong

Source: FDA prescribing information (DailyMed). Set ID: 6008ccac-948e-4b6a-a288-7dd245c2bac4. SPL document ID: 5a71017a-dd08-b810-e063-6294a90a3f14. Label effective date: September 1, 2026. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.