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REXULTI
Mood disorders
Psychosis
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Drug Name:

REXULTI Rx

Generic Name and Formulations:
Brexpiprazole 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg; tabs.

Company:
Otsuka America Pharmaceutical, Inc.

Therapeutic Use:

Indications for REXULTI:

Adjunct therapy for major depressive disorder (MDD).

Adult:

Initially 0.5mg or 1mg once daily; titrate weekly up to target dose of 2mg/day; max 3mg/day. Moderate-to-severe hepatic impairment, or moderate, severe or end-stage renal impairment: max 2mg/day. CYP2D6 poor metabolizers: give ½ of usual dose; and if taking with moderate/strong CYP3A4 inhibitors: give ¼ of usual dose. Concomitant strong CYP2D6 or strong CYP3A4 inhibitors: give ½ of usual dose. Concomitant moderate/strong CYP2D6 with moderate/strong CYP3A4 inhibitors: give ¼ of usual dose. Concomitant strong CYP3A4 inducers: double usual dose over 1–2 weeks.

Children:

Not established.

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. Cardio- or cerebrovascular disease. Discontinue immediately if neuroleptic malignant syndrome is suspected; treat appropriately and monitor. Tardive dyskinesia. Pre-existing low WBC or ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for hyperglycemia/diabetes, dyslipidemia, weight gain. Risk of hypotension, syncope, or aspiration. History of seizures or conditions that lower the seizure threshold. Strenuous exercise. Exposure to extreme heat. Dehydration. Hypovolemia. Perform fall risk assessments when initiating and recurrently on long-term therapy. CYP2D6 poor metabolizers. Renal or moderate-to-severe hepatic impairment. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post-delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:

See Adults. May be potentiated by strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ketoconazole) or strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine). May be antagonized by strong CYP3A4 inducers (eg, rifampin, St. John’s wort). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Weight gain, akathisia, headache, somnolence, tremor, nasopharyngitis, dizziness, anxiety, restlessness.

Generic Availability:

NO

How Supplied:

Tabs—30

Indications for REXULTI:

Schizophrenia.

Adult:

Initially 1mg once daily on Days 1–4; titrate to 2mg once daily on Day 5–7, then to 4mg once daily on Day 8; target dose 2–4mg/day; max 4mg/day. Moderate-to-severe hepatic impairment, or moderate, severe or end-stage renal impairment: max 3mg/day. CYP2D6 poor metabolizers: give ½ of usual dose; and if taking with moderate/strong CYP3A4 inhibitors: give ¼ of usual dose. Concomitant strong CYP2D6 or strong CYP3A4 inhibitors: give ½ of usual dose. Concomitant moderate/strong CYP2D6 with moderate/strong CYP3A4 inhibitors: give ¼ of usual dose. Concomitant strong CYP3A4 inducers: double usual dose over 1–2 weeks.

Children:

Not established.

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. Cardio- or cerebrovascular disease. Discontinue immediately if neuroleptic malignant syndrome is suspected; treat appropriately and monitor. Tardive dyskinesia. Pre-existing low WBC or ANC or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for hyperglycemia/diabetes, dyslipidemia, weight gain. Risk of hypotension, syncope, or aspiration. History of seizures or conditions that lower the seizure threshold. Strenuous exercise. Exposure to extreme heat. Dehydration. Hypovolemia. Perform fall risk assessments when initiating and recurrently on long-term therapy. CYP2D6 poor metabolizers. Renal or moderate-to-severe hepatic impairment. Write ℞ for smallest practical amount. Neonates: risk of extrapyramidal and/or withdrawal symptoms post-delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers.

Interactions:

See Adults. May be potentiated by strong CYP3A4 inhibitors (eg, itraconazole, clarithromycin, ketoconazole) or strong CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine). May be antagonized by strong CYP3A4 inducers (eg, rifampin, St. John’s wort). Potentiates antihypertensives. Caution with drugs that interfere with temperature regulation (eg, anticholinergics).

Pharmacological Class:

Atypical antipsychotic.

Adverse Reactions:

Weight gain, akathisia, headache, somnolence, tremor, nasopharyngitis, dizziness, anxiety, restlessness.

Generic Availability:

NO

How Supplied:

Tabs—30

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