Caplyta for treating schizophrenia and bipolar depression in adults

Caplyta is an oral atypical antipsychotic medication approved for adults to manage schizophrenia, depressive episodes in bipolar I or II disorder, and as additional treatment for major depressive disorder. It is taken once daily in capsule form with flexible dosing for certain patient groups.

• Treatment of schizophrenia in adult patients.
• Treatment of depressive episodes associated with bipolar I or bipolar II disorder in adults, either as monotherapy or adjunctive to lithium or valproate.
• Adjunctive therapy with antidepressants for adults with major depressive disorder (MDD).

lumateperone

Caplyta works by modulating multiple neurotransmitter systems in the brain, particularly affecting dopamine and serotonin receptors, to help regulate mood, perception, and behavior disturbances seen in schizophrenia and mood disorders.

Recommended Dosage

Generally, 42 mg orally once daily with or without food.

Dosage Adjustments

• For patients taking strong CYP3A4 inhibitors, reduce dose to 10.5 mg once daily.
• For patients taking moderate CYP3A4 inhibitors, reduce dose to 21 mg once daily.
• For patients with moderate or severe hepatic impairment (Child-Pugh B or C), reduce dose to 21 mg once daily.
• No dose adjustment needed for mild hepatic impairment.

Formulations

Available capsules: 42 mg (blue cap), 21 mg (white cap), 10.5 mg (light pink cap).

History of hypersensitivity to lumateperone or any components of Caplyta. Hypersensitivity reactions reported include pruritus, various rashes, and urticaria.

Boxed Warning

• Increased mortality in elderly patients with dementia-related psychosis: Antipsychotics increase risk of death in these patients. Caplyta is not approved for dementia-related psychosis.
• Suicidal thoughts and behaviors: Increased risk noted in pediatric and young adult patients treated with antidepressants. Caplyta is not approved for pediatric use. Monitor closely for worsening depression or suicidal ideation.

Other Important Warnings

• Cerebrovascular events: Increased risk of stroke and transient ischemic attack in elderly with dementia.
• Neuroleptic malignant syndrome (NMS): Potentially fatal; discontinue immediately if suspected.
• Tardive dyskinesia: May occur with treatment; assess periodically and consider discontinuation if symptoms develop.
• Metabolic changes: Monitor for hyperglycemia, diabetes, dyslipidemia, and weight gain.
• Leukopenia and neutropenia: Monitor blood counts in at-risk patients; discontinue if severe neutropenia develops.
• Orthostatic hypotension and syncope: Monitor vulnerable patients, especially during initiation.
• Seizures: Use with caution in patients with seizure history or lowered seizure threshold.
• Potential cognitive and motor impairment: Use caution when driving or operating machinery until effects are known.

Common Side Effects

• Somnolence and sedation (reported in 12-24% of patients depending on condition treated)

Serious Side Effects

• Neuroleptic malignant syndrome
• Tardive dyskinesia
• Metabolic disturbances including hyperglycemia and dyslipidemia
• Orthostatic hypotension and syncope
• Leukopenia, neutropenia, and potentially agranulocytosis

• Strong CYP3A4 inhibitors: Require dose reduction to 10.5 mg daily.
• Moderate CYP3A4 inhibitors: Require dose reduction to 21 mg daily.

Pregnancy

No specific pregnancy information provided in the supplied label.

Lactation

No lactation information provided in the supplied label.

Specific signs or management of overdose are not detailed in the provided text.

Storage conditions are not specified in the provided label excerpt.