• Schizophrenia.
• Depressive episodes associated with bipolar I disorder (as monotherapy or in combination with lithium or valproate).

Contraindicated in:

• Hypersensitivity
• Concurrent use of strong CYP3A4 inhibitors or inducers.

Use Cautiously in:

• Moderate or severe renal impairment (dose adjustment recommended)
• Moderate or severe hepatic impairment (dose adjustment recommended)
• History of suicide attempt
• Diabetes mellitus
• Overheating/dehydration (may ↑ risk of serious adverse reactions)
• Patients at risk for falls
• History of leukopenia or previous drug-induced leukopenia/neutropenia
• OB: Use in pregnancy only if potential maternal benefit justifies potential fetal risk
• Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant
• Pedi: May ↑ risk of suicide attempt/ideation especially during dose early treatment or dose adjustment; risk may be greater in children, adolescents, and young adults taking antidepressants; safety and effectiveness not established in children <10 yr
• Geri: Appears on Beers list. ↑ risk of stroke, cognitive decline, and mortality in older adults with dementia. Avoid use in older adults, except for schizophrenia or bipolar disorder.

CV: bradycardia, orthostatic hypotension, syncope, tachycardia.

Derm: pruritus, rash.

EENT: blurred vision.

Endo: hyperglycemia, hyperprolactinemia.

GI: nausea, esophageal dysmotility.

Hemat: AGRANULOCYTOSIS, anemia, leukopenia.

Metab: dyslipidemia, weight gain.

Neuro: akathisia, drowsiness, parkinsonism, agitation, anxiety, cognitive/motor impairment, dizziness, dystonia, NEUROLEPTIC MALIGNANT SYNDROME, SEIZURES, SUICIDAL THOUGHTS, tardive dyskinesia.

Drug-Drug:

• Strong CYP3A4 inhibitors, including ketoconazole, clarithromycin, ritonavir, and voriconazole ↑ levels and risk of toxicity; concurrent use contraindicated.
• Strong CYP3A4 inducers, including rifampin, phenytoin, and carbamazepine ↓ levels and effectiveness; concurrent use contraindicated.
• Moderate CYP3A4 inhibitors, including diltiazem, atazanavir, erythromycin, fluconazole, and verapamil ↑ levels and risk of toxicity; if used concurrently, lurasidone dose should not exceed 40 mg/day.
• ↑ sedation may occur with other CNS depressants, including alcohol, sedative/hypnotics, opioids, some antidepressants and antihistamines.

Drug-Natural Products:

• St. John's wort ↓ levels and effectiveness; concurrent use contraindicated

Drug-Food:

• Grapefruit juice↑ levels and risk of toxicity; concurrent use contraindicated

(Generic available)

• Tablets: 20 mg; 40 mg; 60 mg; 80 mg; 120 mg;

Schizophrenia

• PO (Adults): 40 mg once daily (not to exceed 160 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy: ↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).
• PO (Children 13–17 yr): 40 mg once daily (not to exceed 80 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy: ↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).

Depressive Episodes Associated with Bipolar I Disorder

• PO (Adults): 20 mg once daily (not to exceed 120 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy: ↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).
• PO (Children 10–17 yr): 20 mg once daily (not to exceed 80 mg once daily); Addition of moderate CYP3A4 inhibitor to existing lurasidone therapy: ↓ lurasidone dose by 50%; Addition of lurasidone to existing moderate CYP3A4 inhibitor therapy: 20 mg once daily (not to exceed 80 mg once daily).

Latuda

• Effect may be mediated via effects on central dopamine Type 2 (D₂) and serotonin Type 2 (5HT_2A) receptor antagonism.

• Reduction in schizophrenic behavior.
• Reduction in depressive episodes in bipolar I disorder.

Therapeutic Classification: antipsychotics

Pharmacologic Classification:

Absorption: 9–19% absorbed following oral administration.

Distribution: Unknown.

Protein Binding: >99%.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A4 isoenzyme. Two metabolites are pharmacologically active; 80% eliminated in feces, 8% in urine primarily as metabolites.

Half-life: 18 hr.

(plasma concentrations)

• Instruct patient to take medication as directed. Emphasize the caloric food needs for taking medication.
• Inform patient of the possibility of extrapyramidal symptoms. Instruct patient to report these symptoms immediately to health care professional.
• Advise patient to change positions slowly to minimize orthostatic hypotension. Protect from falls.
• May cause drowsiness and cognitive and motor impairment. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
• Advise patient and family to notify health care professional if thoughts about suicide or dying, attempts to commit suicide; new or worse depression; new or worse anxiety; feeling very agitated or restless; panic attacks; trouble sleeping; new or worse irritability; acting aggressive; being angry or violent; acting on dangerous impulses; an extreme ↑ in activity and talking, other unusual changes in behavior or mood occur.
• Advise patient to avoid extremes in temperature; this drug impairs body temperature regulation.
• Advise patient to tell health care professional what medications they are taking and to avoid taking new Rx, OTC, vitamins, or herbal products without consulting health care professional, especially alcohol and other CNS depressants.
• Advise patient to notify health care professional of medication regimen before treatment or surgery.
• Instruct patient to notify health care professional promptly if sore throat, fever, unusual bleeding or bruising, rash, or tremors occur.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected, and to avoid breastfeeding during therapy. Monitor neonates exposed to lurasidone during the third trimester of pregnancy for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. Monitor breastfed infants for excessive drowsiness, lethargy, and developmental delays. Encourage women who become pregnant while taking lurasidone to enroll in the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage symptoms appropriately.
• Emphasize the importance of routine follow up exams to monitor side effects.

loo-RAS-i-done