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Rexulti

Rexulti Warnings

brexpiprazole

Manufacturer:

Otsuka (Philippines)

Distributor:

Otsuka (Philippines)
Full Prescribing Info
Warnings
Increased Mortality in Elderly Patients with Dementia-Related Psychosis; and Suicidal Thoughts and Behaviors.
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. Brexpiprazole (Rexulti) is not approved for the treatment of patients with dementia-related psychosis without agitation associated with dementia due to Alzheimer's disease [see Increased Mortality in Elderly Patients with Dementia-Related Psychosis under Precautions].
Suicidal Thoughts and Behaviors: Antidepressants increased the risk of suicidal thoughts and behaviors in patients 24 years of age and younger in short-term studies. Monitor closely for clinical worsening and for emergence of suicidal thoughts and behaviors. The safety and efficacy of Brexpiprazole (Rexulti) has not been established in pediatric patients with MDD [see Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults and Use in Children under Precautions].
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