What is Vraylar (cariprazine) approved for?
Vraylar (cariprazine) is approved to treat certain psychiatric conditions, including schizophrenia in adults. [1]
It is also approved for:
- Bipolar I disorder—depressive episodes in adults, and manic or mixed episodes in adults. [1]
- Bipolar I disorder—manic or mixed episodes in pediatric patients ages 10 years and older. [1]
Which Vraylar “indications” cover depression vs mania?
Vraylar’s labeled bipolar uses include both mood phases:
- Bipolar I disorder depressive episodes: indicated for adults. [1]
- Bipolar I disorder manic or mixed episodes: indicated for adults, and also for pediatric patients ages 10+ for manic or mixed episodes. [1]
Are the indications the same for adults and children?
No. The pediatric indication is limited to manic or mixed episodes of bipolar I disorder for ages 10 years and older. Schizophrenia and bipolar depression indications are for adults. [1]
What exactly does “indicated for” mean for clinicians and patients?
“Indicated for” means the specific condition(s), age group(s), and disease phase(s) (for example, depressive vs manic/mixed) that the drug’s labeling supports. For Vraylar, the labeled conditions are schizophrenia (adults) and bipolar I disorder (depression in adults; manic/mixed in adults and ages 10+). [1]
Sources
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207422