Drug Detail:Brexpiprazole (Brexpiprazole [ brex-pip-ra-zole ])
Drug Class: Atypical antipsychotics
Usual Adult Dose for Schizophrenia
Initial dose: 1 mg orally once a day on Days 1 through 4
Titration: Based on clinical response and tolerability, titrate to 2 mg once a day on Day 5 through Day 7, then to 4 mg once a day on Day 8
Target 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 or 1 mg orally once a day
Titration: 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.
Target dose: 2 mg orally once a day
Maximum dose: 3 mg/day
Use: Adjunctive treatment of major depressive disorder (MDD)
Usual Pediatric Dose for Schizophrenia
Initial dose: 0.5 mg orally once a day on Days 1 through 4
Titration: Based on clinical response and tolerability, titrate to 1 mg once a day on Day 5 through Day 7, then to 2 mg once a day on Day 8. Weekly dose increases can be made in 1 mg increments.
Target Dose: 2 to 4 mg orally once a day
Maximum dose: 4 mg/day
Use: Treatment of schizophrenia in children 13 to 17 years of age
Renal Dose Adjustments
Mild Renal Dysfunction (CrCl 60 mL/min and greater): Data not available
Moderate to Severe Renal Dysfunction (CrCl less than 60 mL/min):
- Schizophrenia: Maximum recommended dosage 3 mg/day
- MDD: Maximum recommended dosage 2 mg/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):
- Schizophrenia: Maximum recommended dosage 3 mg/day
- MDD: Maximum recommended dosage 2 mg/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- When coadministered drug is withdrawn, the dose should be adjusted to the original level.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 FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides
CONTRAINDICATIONS:
- Hypersensitivity to the active component or to any of the ingredients
US BOXED WARNINGS:
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS:
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an 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.
- Patients should be closely monitored for clinical worsening and for the emergence of suicidal thoughts and behaviors.
Safety and efficacy have not been established in pediatric patients younger than 13 years old with schizophrenia.
Safety and efficacy have not been established in pediatric patients with MDD.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- This drug may be taken without regard to 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.
General:
- Patients should be reassessed periodically to determine continued need for treatment and appropriate dosage for treatment.
Monitoring:
- METABOLIC: Monitor for increases in blood sugar, weight, and lipids.
- PSYCHIATRIC: Monitor for clinical worsening and suicidality; close supervision of high-risk patients should accompany drug therapy.
- Monitor for pathological gambling and decreased impulse control, especially in those with a history of these behaviors.
Patient advice:
- Read the Patient Information and Instructions for Use.
- Patients, families, and caregivers should report worsening of depression, suicidal ideation, or any unusual changes in behavior, especially during early antidepressant treatment and when doses are adjusted up or down.
- Patients should be advised to speak with health care providers if they plan to take any new medications including over the counter medications as there are potential drug interactions requiring dose adjustments.
- Inform patients that this drug may cause somnolence, and they should avoid driving or operating machinery if these side effects occur.
- 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.
- Advise patients to speak to their healthcare provider if they become pregnant, intend to become pregnant, or are breastfeeding.
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