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VRAYLAR
Mood disorders
Psychosis
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Drug Name:

VRAYLAR Rx

Generic Name and Formulations:
Cariprazine 1.5mg, 3mg, 4.5mg, 6mg; caps.

Company:
Allergan

Therapeutic Use:

Indications for VRAYLAR:

Manic or mixed episodes associated with bipolar I disorder.

Adult:

Initially 1.5mg once daily; increase to 3mg on Day 2; may further adjust by 1.5mg or 3mg increments based on response and tolerability; max 6mg/day. Usual range 3–6mg once daily. Initiating a strong CYP3A4 inhibitor while on Vraylar: reduce Vraylar dose by ½. Initiating Vraylar while already on a strong CYP3A4 inhibitor: give 1.5mg on Days 1 and 3 (no dose on Day 2), then 1.5mg daily from Day 4 onward; increase to max 3mg daily. May need to increase Vraylar dose after withdrawing inhibitor.

Children:

Not established.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue immediately if neuroleptic malignant syndrome is suspected; treat appropriately. Tardive dyskinesia. Diabetes. Monitor for hyperglycemia, hyperlipidemia; do fasting blood glucose and lipids testing initially and during therapy. Monitor for weight gain, extrapyramidal symptoms, akathisia; consider reducing dose or discontinuing. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Hypovolemia. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Cardio- or cerebrovascular disease. Monitor HR and BP. History of seizures. Strenuous exercise. Exposure to extreme heat. Risk for aspiration. Reevaluate periodically. Severe hepatic or renal impairment: not recommended. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:

See Adults. Potentiated by strong CYP3A inhibitors (eg, itraconazole, ketoconazole). Concomitant CYP3A4 inducers (eg, rifampin, carbamazepine): not recommended. Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, restlessness, dizziness, headache, constipation, abdominal pain, nausea, diarrhea, weight gain, fatigue, fever, tachycardia; orthostatic hypotension, hyperglycemia, dysphagia, others.

Generic Availability:

NO

How Supplied:

Caps—30, 90; Blister packs—7 (1.5mg × 1 + 3mg × 6)

Indications for VRAYLAR:

Schizophrenia.

Adult:

Initially 1.5mg once daily; increase to 3mg on Day 2; may further adjust by 1.5mg or 3mg increments based on response and tolerability; max 6mg/day. Usual range 1.5–6mg once daily. Initiating a strong CYP3A4 inhibitor while on Vraylar: reduce Vraylar dose by ½. Initiating Vraylar while already on a strong CYP3A4 inhibitor: give 1.5mg on Days 1 and 3 (no dose on Day 2), then 1.5mg daily from Day 4 onward; increase to max 3mg daily. May need to increase Vraylar dose after withdrawing inhibitor.

Children:

Not established.

Warnings/Precautions:

Elderly with dementia-related psychosis (not approved use); increased risk of death or cerebrovascular events (eg, stroke, TIA). Discontinue immediately if neuroleptic malignant syndrome is suspected; treat appropriately. Tardive dyskinesia. Diabetes. Monitor for hyperglycemia, hyperlipidemia; do fasting blood glucose and lipids testing initially and during therapy. Monitor for weight gain, extrapyramidal symptoms, akathisia; consider reducing dose or discontinuing. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Hypovolemia. Dehydration. Perform fall risk assessments when initiating and recurrently on long-term therapy. Cardio- or cerebrovascular disease. Monitor HR and BP. History of seizures. Strenuous exercise. Exposure to extreme heat. Risk for aspiration. Reevaluate periodically. Severe hepatic or renal impairment: not recommended. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:

See Adults. Potentiated by strong CYP3A inhibitors (eg, itraconazole, ketoconazole). Concomitant CYP3A4 inducers (eg, rifampin, carbamazepine): not recommended. Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, restlessness, dizziness, headache, constipation, abdominal pain, nausea, diarrhea, weight gain, fatigue, fever, tachycardia; orthostatic hypotension, hyperglycemia, dysphagia, others.

Generic Availability:

NO

How Supplied:

Caps—30, 90; Blister packs—7 (1.5mg × 1 + 3mg × 6)

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