Lumateperone tosylate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Black Box Warning
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Increased Mortality in Elderly Patients with Dementia-Related Psychosis
See full prescribing information for complete Boxed Warning.
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.
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Overview
Lumateperone tosylate is an Atypical Antipsychotic that is FDA approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Most common adverse reactions (≥5% and twice the rate of placebo): somnolence/sedation, dry mouth..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
42 mg orally once daily with or without food.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lumateperone tosylate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lumateperone tosylate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Lumateperone tosylate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Lumateperone tosylate in pediatric patients.
Contraindications
Known hypersensitivity to lumateperone or any of its components.
Warnings
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Increased Mortality in Elderly Patients with Dementia-Related Psychosis
See full prescribing information for complete Boxed Warning.
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.
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Increased mortality in elderly patients with dementia-related psychosis.
Suicidal thoughts and behaviors in children, adolescents, and young adults.
Neuroleptic malignant syndrome,
Tardive dyskinesia,
Metabolic changes (e.g., hyperglycemia, dyslipidemia, weight gain).
Leukopenia, neutropenia, and agranulocytosis.
Orthostatic hypotension and syncope,
Falls,
Seizures,.
Potential for cognitive and motor impairment.
Body temperature dysregulation.
Dysphagia.
Adverse Reactions
Clinical Trials Experience
somnolence/sedation and dry mouth.
Postmarketing Experience
There is limited information regarding Lumateperone tosylate Postmarketing Experience in the drug label.
Drug Interactions
Avoid concomitant use with strong CYP3A4 inhibitors or inducers.
Use caution with other centrally acting drugs.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Lumateperone tosylate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Lumateperone tosylate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Lumateperone tosylate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Lumateperone tosylate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Lumateperone tosylate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Lumateperone tosylate in geriatric settings.
Gender
There is no FDA guidance on the use of Lumateperone tosylate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Lumateperone tosylate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Lumateperone tosylate in patients with renal impairment.
Hepatic Impairment
Avoid use in moderate to severe hepatic impairment.
Females of Reproductive Potential and Males
May impair fertility.
Immunocompromised Patients
There is no FDA guidance one the use of Lumateperone tosylate in patients who are immunocompromised.
Administration and Monitoring
Administration
Administer 42 mg orally once daily with or without food.
Monitoring
Monitor for adverse reactions, especially during initial therapy.
IV Compatibility
Not applicable.
Overdosage
Overdose information is limited; symptoms may include extrapyramidal symptoms, sedation.
Management: Provide supportive care; consider contacting a poison control center.
Pharmacology
There is limited information regarding Lumateperone tosylate Pharmacology in the drug label.
Mechanism of Action
The mechanism of action of lumateperone in the treatment of schizophrenia is unknown. However, the efficacy of lumateperone could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
Structure
There is limited information regarding Lumateperone tosylate Structure in the drug label.
Pharmacodynamics
Lumateperone exhibits high affinity for serotonin 5-HT₂A receptors and moderate affinity for dopamine D₂ receptors. It also inhibits the serotonin transporter (SERT), contributing to its antidepressant properties.
Pharmacokinetics
After oral administration, lumateperone reaches peak plasma concentrations within 1–2 hours. It has a terminal elimination half-life of approximately 13–21 hours, supporting once-daily dosing.
Nonclinical Toxicology
There is limited information regarding Lumateperone tosylate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Lumateperone tosylate Clinical Studies in the drug label.
How Supplied
Form: Capsules
Strength: 42 mg
Packaging: Bottles containing 30 capsules
Storage
Storage Conditions: Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Administration: Advise patients to take CAPLYTA exactly as prescribed, once daily with or without food.
Potential Side Effects: Inform patients about possible side effects, including somnolence, dry mouth, and dizziness.
Precautions: Caution patients about engaging in activities requiring mental alertness, such as driving, until they know how CAPLYTA affects them.
Pregnancy and Lactation: Advise women of reproductive potential to inform their healthcare provider if they are pregnant or plan to become pregnant. Breastfeeding is not recommended during treatment with CAPLYTA.
Precautions with Alcohol
Advise patients to avoid alcohol while taking CAPLYTA, as it may exacerbate certain side effects such as sedation and dizziness.
Brand Names
CAPLYTA®
Manufactured by Intra-Cellular Therapies, Inc.
Look-Alike Drug Names
There is limited information regarding Lumateperone tosylate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.