Select therapeutic use:

Mood disorders:

Indications for: CAPLYTA

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

Adult Dosage:

42mg once daily. Moderate to severe hepatic impairment, or concomitant with moderate CYP3A4 inhibitors: reduce dose to 21mg once daily. Concomitant strong CYP3A4 inhibitors: reduce dose to 10.5mg once daily.

Children Dosage:

Not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.

CAPLYTA Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in all patients. Discontinue immediately if neuroleptic malignant syndrome is suspected. Cardio- or cerebrovascular disease. Risk for hypotension, aspiration, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC or ANC, or a history of leukopenia/neutropenia; monitor CBC during 1st few months of treatment; consider discontinuing at 1st sign of significant decline in WBC occurs in absence of other causative factors. Exposure to extreme heat. Dehydration. Hypovolemia. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Reevaluate periodically. Write ℞ for smallest practical amount. Moderate to severe hepatic impairment: reduce dose (see Adult). Neonates: risk for extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.

CAPLYTA Classification:

Atypical antipsychotic.

CAPLYTA Interactions:

Potentiated by moderate or strong CYP3A4 inhibitors (eg, diltiazem, itraconazole); reduce dose (see Adult). Antagonized by CYP3A4 inducers (eg, rifampin); avoid. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Adverse Reactions:

Somnolence/sedation, dry mouth, dizziness, nausea; tardive dyskinesia (consider discontinuation if occurs), neutropenia, orthostatic hypotension, syncope.

Note:

Register patients in the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Drug Availability:

NO

How Supplied:

Caps—30

Pricing for CAPLYTA

30 capsules of 42mg package (Qty: 1)
Appx. price $1521
GoodRx

Psychosis:

Indications for: CAPLYTA

Schizophrenia.

Adult Dosage:

42mg once daily. Moderate to severe hepatic impairment, or concomitant with moderate CYP3A4 inhibitors: reduce dose to 21mg once daily. Concomitant strong CYP3A4 inhibitors: reduce dose to 10.5mg once daily.

Children Dosage:

Not established.

Boxed Warning:

Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.

CAPLYTA Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Increased risk of suicidal thoughts and behavior in children, adolescents, and young adults; monitor closely for worsening or unusual changes in all patients. Discontinue immediately if neuroleptic malignant syndrome is suspected. Cardio- or cerebrovascular disease. Risk for hypotension, aspiration, seizures, or diabetes (do baseline fasting blood sugar). Pre-existing low WBC or ANC, or a history of leukopenia/neutropenia; monitor CBC during 1st few months of treatment; consider discontinuing at 1st sign of significant decline in WBC occurs in absence of other causative factors. Exposure to extreme heat. Dehydration. Hypovolemia. Perform fall risk assessments when initiating and recurrently on long-term therapy. Monitor for hyperglycemia, dyslipidemia, weight gain. Reevaluate periodically. Write ℞ for smallest practical amount. Moderate to severe hepatic impairment: reduce dose (see Adult). Neonates: risk for extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.

CAPLYTA Classification:

Atypical antipsychotic.

CAPLYTA Interactions:

Potentiated by moderate or strong CYP3A4 inhibitors (eg, diltiazem, itraconazole); reduce dose (see Adult). Antagonized by CYP3A4 inducers (eg, rifampin); avoid. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Adverse Reactions:

Somnolence/sedation, dry mouth, dizziness, nausea; tardive dyskinesia (consider discontinuation if occurs), neutropenia, orthostatic hypotension, syncope.

Note:

Register patients in the National Pregnancy Registry for Atypical Antipsychotics (866) 961-2388.

Generic Drug Availability:

NO

How Supplied:

Caps—30

Pricing for CAPLYTA

30 capsules of 42mg package (Qty: 1)
Appx. price $1521
GoodRx