Lurasidone

Lurasidone hydrochloride tablets are indicated for: • Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see Clinical Studies ( 14.1 )] . • 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 should be taken with food (at least 350 calories)
• Administration with food substantially increases the absorption of lurasidone hydrochloride tablets
• Indication Starting Dose Recommended Dose Schizophrenia – adults 40 mg per day 40 mg to 160 mg per day Schizophrenia – adolescents (13 to 17 years) 40 mg per day 40 mg to 80 mg per day Bipolar Depression - adults 20 mg per day 20 mg to 120 mg per day Bipolar Depression – pediatric patients (10 to 17 years) 20 mg per day 20 mg to 80 mg per day • Moderate and Severe Renal Impairment: Recommended starting dose is 20 mg per day, and the maximum recommended dose is 80 mg per day . • Moderate and Severe Hepatic Impairment: Recommended starting dose is 20 mg per day
• The maximum recommended dose is 80 mg per day in moderate hepatic impairment and 40 mg per day in severe hepatic impairment . • Concomitant Use of a Moderate CYP3A4 inhibitor (e.g., diltiazem): Lurasidone hydrochloride tablets dose should be reduced to half of the original dose level
• Recommended starting dose is 20 mg per day
• Maximum recommended dose is 80 mg per day . • Concomitant Use of a Moderate CYP3A4 Inducer: It may be necessary to increase the dose of lurasidone hydrochloride tablets
• Schizophrenia
• Adults The recommended starting dose of lurasidone hydrochloride tablets is 40 mg once daily
• Initial dose titration is not required. …

Lurasidone hydrochloride tablets are available in the following shape and color (Table 1) with respective one-sided debossing. Table 1: Lurasidone Hydrochloride Tablets Presentations Tablet Strength Tablet Color/Shape Tablet Markings 20 mg white to off white, round, biconvex tablets debossed with "L" on one side and "1" on the other side. Tablets: 20 mg( 3 )

• Schizophrenia The safety and effectiveness of lurasidone hydrochloride 40-mg/day and 80-mg/day
• For the treatment of schizophrenia in adolescents (13 to 17 years) was established in a 6-week, placebo-controlled clinical study in 326 adolescent patients [see Dosage and Administration , Adverse Reactions , and Clinical Studies ]
• The safety and effectiveness of lurasidone hydrochloride has not been established
• In pediatric patients less than 13 years of age with schizophrenia. …

Clinical studies with lurasidone hydrochloride did not include sufficient numbers of patients aged 65 and older to determine whether or not they respond differently from younger patients. In elderly patients with psychosis (65 to 85), lurasidone hydrochloride tablets concentrations (20 mg/day) were similar to those in young subjects. It is unknown whether dose adjustment is necessary on the basis of age alone. …

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Suicidal Thoughts and Behavior Advise patients and caregivers to look for the emergence of suicidality, especially early during treatment and when the dosage is adjusted up or down and instruct them to report such symptoms to the healthcare provider [see Boxed Warning, Warnings and Precautions ]
• Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction referred to as Neuroleptic Malignant Syndrome (NMS). …

• Known hypersensitivity to lurasidone HCl or any components in the formulation
• Angioedema has been observed with lurasidone [see Adverse Reactions ]. • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see Drug Interactions ]. • Strong CYP3A4 inducers (e.g., rifampin, avasimibe, St
• John’s wort, phenytoin, carbamazepine, etc.) [see Drug Interactions ]. …

7.1 Drugs Having Clinically Important Interactions with Lurasidone Hydrochloride Table 34: Clinically Important Drug Interactions with Lurasidone Hydrochloride Strong CYP3A4 Inhibitors Clinical Impact: Concomitant use of lurasidone hydrochloride with strong CYP3A4 inhibitors increased the exposure of lurasidone compared to the use of lurasidone hydrochloride alone [see Clinical Pharmacology ( 12.3 )]. Intervention: Lurasidone hydrochloride should not be used concomitantly with strong CYP3A4 inhibitors [see Contraindications ( 4 )]. …

• 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 ). …

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 Precau …

8.1 Pregnancy Risk Summary Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery [see Clinical Considerations]. There are no studies of lurasidone hydrochloride use in pregnant women. The limited available data are not sufficient to inform a drug-associated risk of birth defects or miscarriage. …

10.1 Human Experience In premarketing clinical studies, accidental or intentional overdosage of lurasidone hydrochloride was identified in one patient who ingested an estimated 560 mg of lurasidone hydrochloride. This patient recovered without sequelae. This patient resumed lurasidone hydrochloride treatment for an additional two months. 10.2 Management of Overdosage No specific antidotes for lurasidone hydrochloride are known. In managing overdose, provide supportive care, including close medical supervision and monitoring, and consider the possibility of multiple drug involvement. …

9.1 Controlled Substance Lurasidone hydrochloride is not a controlled substance. 9.2 Abuse Lurasidone hydrochloride has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with lurasidone hydrochloride did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or …

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