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LATUDA
Mood disorders
Psychosis
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Drug Name:

LATUDA Rx

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

Company:
Sunovion

Therapeutic Use:

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 (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin): 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 for clinical worsening or behavior changes in all patients. Not for use in children with depression. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Hypovolemia. Dehydration. 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. Perform fall risk assessments when initiating and recurrently on long-term therapy. Write ℞ for smallest practical amount. Pregnancy. Nursing mothers.

Interactions:

See Adults and Contraindications. Avoid grapefruit and grapefruit juice.

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Somnolence, akathisia, extrapyramidal symptoms, nausea, rhinitis/rhinorrhea (80mg), vomiting; orthostatic hypotension and syncope possible.

How Supplied:

Tabs—30, 90, 500

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, 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 (eg, bosentan, efavirenz, etravirine, modafinil, nafcillin): may need to increase lurasidone dose after chronic treatment (≥7 days) with inducer.

Children:

<13yrs: not established. Take with food (≥350 calories). 13–17yrs: initially 40mg once daily. Usual range: 40–80mg/day; max 80mg/day. Dose modifications: see Adult.

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 for clinical worsening or behavior changes in all patients. Not for use in children with depression. Discontinue if neuroleptic malignant syndrome occurs; consider discontinuing if tardive dyskinesia occurs. Cardio- or cerebrovascular disease. Hypovolemia. Dehydration. 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. Perform fall risk assessments when initiating and recurrently on long-term therapy. Write ℞ for smallest practical amount. Pregnancy. Nursing mothers.

Interactions:

See Adults and Contraindications. Avoid grapefruit and grapefruit juice.

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Somnolence, akathisia, extrapyramidal symptoms, nausea, rhinitis/rhinorrhea (80mg), vomiting; orthostatic hypotension and syncope possible.

How Supplied:

Tabs—30, 90, 500

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