👶Pregnancy
Brexpiprazole crosses the placenta. Overall, second-generation antipsychotics have not shown a major increase in congenital malformations as a class, but data for brexpiprazole specifically are limited. Third-trimester exposure to antipsychotics can cause neonatal EPS or withdrawal (eg, agitation, abnormal muscle tone, feeding or breathing problems). Tapering late in pregnancy is not routinely recommended because relapse risk is high; instead, use the lowest effective dose and monitor the newborn closely after birth.🤱Breastfeeding
Brexpiprazole is present in breast milk at low levels, but case reports describe reduced milk production that improved after the drug was stopped. Antipsychotic exposure through breast milk may cause sedation, poor feeding, or motor changes in infants. Decisions about breastfeeding while on brexpiprazole should weigh maternal benefit, the importance of breastfeeding, and potential infant exposure, with close infant monitoring if breastfeeding continues.👧Children & Adolescents (Under 18)
Approved for schizophrenia in adolescents ≥13 years; safety and efficacy for depression or Alzheimer’s agitation are not established in children. Antipsychotics in youth require careful indication, close monitoring for metabolic and movement side effects, and regular re-evaluation of the need for ongoing treatment.👴Older Adults (65+)
Older adults are more sensitive to orthostatic hypotension, sedation, falls, metabolic changes, and cerebrovascular events. Use the lowest effective dose, titrate slowly, and reassess regularly. There is a boxed warning for increased mortality and stroke risk in older adults with dementia-related psychosis; brexpiprazole is only approved in this population for agitation associated with dementia due to Alzheimer disease.🔬Liver Impairment
In moderate to severe hepatic impairment (Child-Pugh B or C), lower maximum doses are recommended (eg, 3 mg/day for schizophrenia; 2 mg/day for MDD adjunct and Alzheimer’s agitation).💧Kidney Impairment
In moderate to severe renal impairment (CrCl <60 mL/min), lower maximum doses are recommended (3 mg/day schizophrenia; 2 mg/day MDD adjunct and Alzheimer’s agitation). No adjustment is needed for CrCl ≥60 mL/min.