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Brexpiprazole Dosage

Applies to the following strengths: 0.25 mg; 0.5 mg; 1 mg; 2 mg; 3 mg; 4 mg

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Schizophrenia

Initial dose: 1 mg orally once a day on Days 1 through 4
Titration regimen: Based on clinical response and tolerability, titrate to 2 mg once a day on Days 5 to 7, then to 4 mg once a day on Day 8.
Maintenance dose: 2 to 4 mg orally once a day
Maximum dose: 4 mg/day

Use: Treatment of schizophrenia

Usual Adult Dose for Depression

Initial dose: 0.5 mg to 1 mg orally once a day
Titration regimen: Based on clinical response and tolerability, dose increases should be done at weekly intervals; titrate to 1 mg once a day, then up 2 mg once a day.
Maintenance dose: 2 mg orally once a day
Maximum dose: 3 mg/day

Comment: Healthcare providers should periodically reassess the need for maintenance treatment.

Use: Adjunctive treatment of major depressive disorder (MDD)

Renal Dose Adjustments

Mild Renal Dysfunction (CrCl 60 mL/min and greater): Data not available
Moderate to Severe Renal Dysfunction and end-stage renal dysfunction (CrCl less than 60 mL/min):
-MDD: Up to 2 mg orally once a day
-Schizophrenia: Up to 3 mg orally once a day

Liver Dose Adjustments

Mild Liver Dysfunction (Child Pugh score less than 7): Data not available
Moderate to Severe Liver Dysfunction (Child-Pugh score 7 or higher):
-MDD: Up to 2 mg orally once a day
-Schizophrenia: Up to 3 mg orally once a day

Dose Adjustments

Elderly patients: Dose selection should be cautious, usually starting at the low end of the dosing range.

CYP450 Dose Adjustments:
-Known CYP450 2D6 poor metabolizers (PM): Administer one-half usual dose.
-Known CYP450 2D6 PM receiving concomitant strong/moderate CYP450 3A4 inhibitors: Administer one-quarter usual dose.
-Concomitantly receiving strong CYP450 2D6 OR 3A4 inhibitors: Administer one-half usual dose.
-Concomitantly receiving strong/moderate CYP450 2D6 AND strong/moderate CYP450 3A4 inhibitors: Administer one-quarter usual dose.
-Concomitantly receiving CYP450 3A4 inducer: Double the usual dose over 1 to 2 weeks.

IMPORTANT NOTES:
-When coadministered drug is withdrawn, the dose should be adjusted to the original level.
-When coadministered CYP450 3A4 inducer is withdrawn, the dose of this drug should be adjusted to the original level over 1 to 2 weeks.

Precautions

US BOXED WARNINGS:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:
-Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at increased risk of death.
-This drug is not approved for the treatment of patients with dementia-related psychosis.

SUICIDAL THOUGHTS AND BEHAVIORS:
-Antidepressants increase the risk of suicidal thoughts and behaviors in patients aged 24 years and younger in short-term studies.
-Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors.
-The safety and effectiveness of this drug have not been established in pediatric patients.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-May be taken with or without food.
-If a dose is missed, take the missed dose as soon as remembered, however, if close to next dose, skip missed dose; do not take 2 doses at the same time.

Storage requirements:
-Store below 30C.

General:
-Patients should be reassessed periodically to determine continued need for treatment and appropriate dosage for treatment.

Monitoring:
-Cardiovascular: Orthostatic vital signs in at-risk patients
-Hematologic: CBC frequently during the first few months in patients with preexisting low WBC and/or a prior history of drug-induced leukopenia or neutropenia
-Metabolic: Monitor for increases in blood sugar, weight, and lipids

Patient advice:
-Patients, families, and caregivers should be educated on the risks of suicidal thoughts and behaviors, as well as the risk of mania and hypomania; what to watch for and when to seek medical advice.
-This drug may impair judgment, thinking, or motor skills; have patient avoid driving or operating machinery until adverse effects are determined.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.
-Advise patient that this drug may cause metabolic changes such as increases in blood sugar, body weight and lipids.
-Patients should avoid overheating and dehydration.
-Patients should speak with their healthcare provider if they are taking, or plan to take any new prescription or over the counter medications because there is a potential for drug interactions; patients should be advised to avoid alcohol as it may make some side effects worse.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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