Latuda (lurasidone HCl)

Dosage of lurasidone hydrochloride is expressed in terms of the hydrochloride salt.

Lurasidone hydrochloride is commercially available as tablets, which are administered orally once daily, usually in the morning or evening, and should be taken with food (containing at least 350 calories) to increase absorption. Food increases peak concentrations and AUC of lurasidone threefold and twofold, respectively; however, lurasidone exposure was not affected as meal size was increased from 350 to 1000 calories and was independent of meal fat content. Lurasidone was administered with food in the controlled clinical studies.

Store lurasidone tablets at 25degreesC; excursions permitted to 15-30degreesC.

No dosing information is available for this tab.

No dosing information is available for this tab.

Lurasidone is primarily metabolized by cytochrome P-450 (CYP) isoenzyme 3A4. Lurasidone is not a substrate of CYP isoenzymes 1A1, 1A2, 2A6, 4A11, 2B6, 2C8, 2C9, 2C19, 2D6, or 2E1. Lurasidone is not a substrate of organic anion transporter polypeptide (OATP) 1B1 or OATP1B3, but is likely a substrate of P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Lurasidone is not expected to inhibit OATP1B1, OATP1B3, organic cation transporter (OCT) 1, OCT2, organic anion transporter (OAT)1, OAT3, multidrug and toxin extrusion transporter (MATE)1, MATE2K, or bile salt exporter pump (BSEP) at clinically relevant concentrations. Lurasidone is not a clinically important inhibitor of P-gp, but may inhibit BCRP.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

*Known hypersensitivity to lurasidone hydrochloride or any components in the formulation. Angioedema has been reported.

*Concurrent use of strong cytochrome P-450 (CYP) isoenzyme 3A4 inhibitors (e.g., clarithromycin, ketoconazole, ritonavir, voriconazole) or strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's wort (Hypericum perforatum)).

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

Adverse effects occurring in >=5% of adult patients receiving lurasidone for schizophrenia and at a frequency at least twice that reported with placebo include somnolence (including hypersomnia, hypersomnolence, and sedation), akathisia, extrapyramidal symptoms (including parkinsonian symptoms and dyskinesia), and nausea.

Adverse effects occurring in >=5% of adolescent patients (13-17 years of age) receiving lurasidone for schizophrenia and at a frequency at least twice that reported with placebo include somnolence (including hypersomnia, hypersomnolence, and sedation), nausea, akathisia, extrapyramidal symptoms (non-akathisia), rhinitis (80 mg dosage only) and vomiting.

Adverse effects occurring in >=5% of adult patients receiving lurasidone for bipolar depression as monotherapy or as adjunctive therapy with lithium or valproate and at a frequency at least twice that reported with placebo include somnolence (including hypersomnia, hypersomnolence, and sedation), akathisia, and extrapyramidal symptoms (including parkinsonian symptoms and dyskinesia).

Adverse effects occurring in >=5% of pediatric patients (10-17 years of age) receiving lurasidone as monotherapy for bipolar depression and at a frequency at least twice that reported with placebo include nausea, weight increase, and insomnia.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

Safety and effectiveness of lurasidone 40-80 mg daily for the treatment of schizophrenia have been established in adolescent patients 13-17 years of age. Safety and efficacy for this indication was established in a 6-week, placebo-controlled study in 326 adolescent patients. Safety and efficacy of lurasidone for schizophrenia have not been established in pediatric patients <13 years of age.

Safety and efficacy of lurasidone 20-80 mg daily for the treatment of bipolar depression have been established in pediatric patients 10-17 years of age. Safety and efficacy for this indication was established in a 6-week, placebo-controlled study in 347 pediatric patients. Safety and efficacy of lurasidone for bipolar depression have not been established in pediatric patients <10 years of age.

Efficacy of lurasidone for the treatment of irritability associated with autistic disorder have not been established in pediatric patients. Treatment with lurasidone 20 mg daily and 60 mg daily failed to demonstrate efficacy in a 6-week study in pediatric patients 6-17 years of age with irritability associated with autistic disorder diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 4th Ed. (DSM-IV) criteria. The primary endpoint of an improvement from baseline in the irritability subscale of the Aberrant Behavior Checklist (ABC) was not met at 6 weeks.

In long term (104-week), open-label study of pediatric patients 6-17 years of age with schizophrenia, bipolar depression, or autistic disorder, z-scores were derived for height based on standardized growth curves adjusted for age and sex. There was minimal deviation from the growth curve in the study.

A pregnancy registry is available that monitors pregnancy outcomes in women exposed to lurasidone during pregnancy. For more information, contact the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregi stry/.

Neonates exposed to antipsychotic agents during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Symptoms reported to date have included agitation, hypertonia, hypotonia, tardive dyskinetic-like symptoms, tremor, somnolence, respiratory distress, and feeding disorder. Monitor neonates for extrapyramidal and/or withdrawal symptoms and manage appropriately. The symptoms have varied in severity; some neonates recovered within hours to days without specific treatment while others have required prolonged hospitalization.

Lactation studies have not been conducted to assess the presence of lurasidone in human milk. The effects of lurasidone on the breast-fed infant or on milk production are not known. Lurasidone is distributed into milk in rats. The developmental and health benefits of breast-feeding should be weighed along with the mother's clinical need for the drug and any potential adverse effects on the breast-fed infant from lurasidone or from the underlying maternal condition.

The manufacturer states that it is not known whether dosage adjustment is necessary in geriatric patients on the basis of age alone.

Clinical trial experience with lurasidone in patients with schizophrenia who are >=65 years of age is insufficient to determine whether they respond differently than younger adults.

In geriatric patients (65-85 years of age) with psychosis, serum lurasidone concentrations were similar to those observed in younger adults. The manufacturer states that it is unknown whether dosage adjustment is necessary in geriatric patients on the basis of age alone.

Geriatric patients with dementia-related psychosis treated with lurasidone are at an increased risk of death compared with those treated with placebo. In addition, an increased incidence of adverse cerebrovascular events (cerebrovascular accidents and transient ischemic attacks), including fatalities, has been observed in geriatric patients with dementia-related psychosis treated with certain atypical antipsychotic agents (aripiprazole, olanzapine, risperidone) in placebo-controlled studies. The manufacturer states that lurasidone is not approved for the treatment of patients with dementia-related psychosis.

In pooled data analyses, a reduced risk of suicidality was observed in adults >=65 years of age with antidepressant therapy compared with placebo.