Mood disorders:
Indications for: VRAYLAR
Manic, mixed or depressive episodes associated with bipolar I disorder. Adjunct to antidepressants for major depressive disorder (MDD).
Adult Dosage:
Manic, mixed episodes: 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. Bipolar I depressive episodes, adjunct to MDD: initially 1.5mg once daily; may increase to 3mg on Day 15 based on response and tolerability; max 3mg/day. 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 Dosage:
Not established.
Boxed Warning:
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.
VRAYLAR 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 for clinical worsening or behavior changes in all patients. 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 WBC or ANC, or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline or ANC <1000/mm3. 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.
VRAYLAR Classification:
Atypical antipsychotic.
VRAYLAR 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).
Adverse Reactions:
Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, restlessness, nausea, fatigue, constipation, insomnia, increased appetite, dizziness; orthostatic hypotension, hyperglycemia, dyslipidemia, weight gain, dysphagia, neutropenia, leukopenia.
Drug Elimination:
Renal (~21%). Half-life: 31.6–68.4 hours.
Generic Drug Availability:
NO
How Supplied:
Caps—30, 90; Blister packs—7 (1.5mg; 1.5mg × 1 + 3mg × 6)
Psychosis:
Indications for: VRAYLAR
Schizophrenia.
Adult Dosage:
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 Dosage:
Not established.
Boxed Warning:
Increased mortality in elderly patients with dementia-related psychosis. Suicidal thoughts and behaviors.
VRAYLAR 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 for clinical worsening or behavior changes in all patients. 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 WBC or ANC, or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline or ANC <1000/mm3. 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.
VRAYLAR Classification:
Atypical antipsychotic.
VRAYLAR 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).
Adverse Reactions:
Extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, restlessness, nausea; orthostatic hypotension, hyperglycemia, dyslipidemia, weight gain, dysphagia, neutropenia, leukopenia.
Drug Elimination:
Renal (~21%). Half-life: 31.6–68.4 hours.
Generic Drug Availability:
NO
How Supplied:
Caps—30, 90; Blister packs—7 (1.5mg; 1.5mg × 1 + 3mg × 6)
