Lumateperone (1 brand name, 1 dosage form, 0 routes)
Available dosage forms: CAPSULE.
Brand Names
- LUMATEPERONE
Boxed Warning
Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions (5.1)]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors [see Warnings and Precautions (5.2)]. The safety and effectiveness of CAPLYTA have not been established in pediatric patients [see Use in Specific Populations (8.4)].
Indications and Usage
CAPLYTA is indicated for: Treatment of schizophrenia in adults [see Clinical Studies (14.1)]. Treatment of depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults, as monotherapy and as adjunctive therapy with lithium or valproate [see Clinical Studies (14.2)]. Adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies ( 14.3 ) ].
Contraindications
CAPLYTA is contraindicated in patients with history of hypersensitivity reaction to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g. allergic dermatitis, papular rash, and generalized rash), and urticaria.
Adverse Reactions
The following adverse reactions are discussed in detail in other sections of the labeling: Increased Mortality in Elderly Patients with Dementia-Related Psychosis [see Boxed Warning, Warnings and Precautions (5.1)] Suicidal Thoughts and Behaviors [see Boxed Warning, 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)] Leukopenia, Neutropenia, and Agranulocytosis [see Warnings and Precautions (5.7)] Orthostatic Hypotension and Syncope [see Warnings and Precautions (5.8)] Falls [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Potential for Cognitive and Motor Impairment [see Warnings and Precautions (5.11)] Body Temperature Dysregulation [see Warnings and Precautions (5.12)] Dysphagia [see Warnings and Precautions (5.13)]
Mechanism of Action
The mechanism of action of lumateperone for the treatment of schizophrenia in adults, for the treatment of depressive episodes associated with bipolar depression (as monotherapy or as adjunctive therapy with lithium or valproate), and as adjunctive therapy with antidepressants for the treatment of MDD is unknown. However, the mechanism of action of lumateperone for these uses could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors, and partial agonist activity at central dopamine D2 receptors.
Overdosage
No specific antidotes for CAPLYTA are known. In managing a CAPLYTA overdose, provide supportive care, including close medical supervision and monitoring and consider the possibility of multiple drug involvement. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.