INDICATION AND USES:

CAPLYTA is an atypical antipsychotic indicated for the treatment of:

• Schizophrenia in adults. (1)
• Depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate. (1)

DOSAGE AND ADMINISTRATION:

• The recommended dosage of CAPLYTA is 42 mg once daily with or without food. (2.1)
• Dose titration is not required. (2.1)
• Moderate or severe hepatic impairment: Recommended dosage is 21 mg once daily (2.3, 8.6)

DOSAGE FORMS AND STRENGTHS:

• Capsules: 42 mg, 21 mg, 10.5 mg (3)

SIDE EFFECTS:

Most common adverse reactions in clinical trials (incidence > 5% and greater than twice placebo) were (6.1):

• Schizophrenia: somnolence/sedation and dry mouth
• Bipolar depression: somnolence/sedation, dizziness, nausea, dry mouth.

To report SUSPECTED ADVERSE REACTIONS, contact Intra-Cellular Therapies, Inc. at 1-888-611-4824 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

CONTRAINDICATIONS:

Known hypersensitivity to lumateperone or any components of CAPLYTA. (4)

WARNINGS AND PRECAUTIONS:

• Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke and transient ischemic attack). (5.2)
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. (5.3)
• Tardive Dyskinesia: Discontinue treatment if clinically appropriate. (5.4)
• Metabolic Changes: Monitor for hyperglycemia/diabetes mellitus, dyslipidemia, and weight gain. (5.5)
• Leukopenia, Neutropenia, and Agranulocytosis: Perform complete blood counts (CBC) in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. Consider discontinuing CAPLYTA if clinically significant decline in WBC occurs in absence of other causative factors. (5.6)
• Orthostatic Hypotension and Syncope: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope. (5.7)
• Seizures: Use cautiously in patients with a history of seizure or with conditions that lower seizure threshold. (5.9)
• Potential for Cognitive and Motor Impairment: Use caution when operating machinery. (5.10)

DRUG INTERACTIONS:

CYP3A4 inducers: Avoid concomitant use. (2.2, 7.1) · Moderate or strong CYP3A4 inhibitors: Avoid concomitant use. (2.2, 7.1)

OVERDOSE: No specific antidotes for CAPLYTA are known. In managing overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. In case of overdose, consult a Certified Poison Control Center (1-800-222-1222 or www.poison.org).