Generic Name and Formulations:
Lurasidone HCl 20mg, 40mg, 60mg, 80mg, 120mg; tabs.

Company:
Sunovion
Indications for LATUDA:
Major depressive episodes associated with bipolar I disorder as monotherapy and as adjunctive therapy with lithium or valproate.

Adult:
Take with food (≥350 calories). Initially 20mg once daily. Usual range: 20–120mg/day. Max 120mg/day. Moderate (CrCl 30 to <50mL/min) to severe renal impairment (CrCl <30mL/min), moderate hepatic impairment (Child Pugh Score 7–9): initially 20mg; max 80mg/day. Severe hepatic impairment (Child Pugh Score 10–15): initially 20mg; max 40mg/day. If moderate CYP3A4 inhibitors (eg, diltiazem, atazanavir, erythromycin, fluconazole, verapamil) is added concomitant to prescribed lurasidone therapy: reduce lurasidone dose to ½ of the original dose; if lurasidone is added concomitant to prescribed moderate CYP3A4 therapy: initially 20mg/day; max 80mg/day. Concomitant moderate CYP3A4 inducers: may need to increase lurasidone dose after chronic treatment (≥7 days) with inducer.

Children:
Not established.

Contraindications:
Concomitant strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) and inducers (eg, rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine).

Warnings/Precautions:
Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in behavior in all patients. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease, risk of hypotension: monitor orthostatic vital signs. Diabetes risk factors (obtain baseline fasting blood sugar). Monitor for hyperglycemia, dyslipidemia, weight gain, hyperprolactinemia. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of therapy; discontinue if WBCs decline. Moderate to severe hepatic or renal impairment. History of seizures. Mania or hypomania (monitor). Dysphagia. Parkinson's disease. Dementia with Lewy Bodies. Exposure to extreme heat. Write ℞ for smallest practical amount; closely supervise high-risk patients (suicidal ideation). Pregnancy (Cat. B). Nursing mothers: not recommended.

Interactions:
See Adults and Contraindications. Avoid grapefruit and grapefruit juice.

Pharmacological Class:
Atypical antipsychotic (benzoisothiazol derivative).

Adverse Reactions:
Somnolence, akathisia, extrapyramidal symptoms, nausea, parkinsonism, agitation; orthostatic hypotension and syncope possible.

How Supplied:
Tabs—30, 90, 500, 100 (10 blister cards x 10 tabs)
Indications for LATUDA:
Schizophrenia.

Adult:
Take with food (≥350 calories). Initially 40mg once daily. Usual range: 40–160mg/day. Max 160mg/day. Moderate (CrCl 30 to <50mL/min) to severe renal impairment (CrCl <30mL/min), moderate hepatic impairment (Child Pugh Score 7–9): initially 20mg; max 80mg/day. Severe hepatic impairment (Child Pugh Score 10–15): initially 20mg; max 40mg/day. If moderate CYP3A4 inhibitors (eg, diltiazem, atazanavir, erythromy