Vraylar FDA Approval for Pediatric Use
Yes, Vraylar (cariprazine) is FDA approved for children, specifically for schizophrenia in ages 13 years and older, and for acute manic or mixed episodes of bipolar I disorder in ages 10 years and older. 1
FDA-Approved Pediatric Indications
According to the current FDA labeling, Vraylar is approved for:
- Schizophrenia: Children and adolescents ages 13 years and older 1
- Bipolar I disorder (acute manic or mixed episodes): Children and adolescents ages 10 years and older 1
Not Approved For
Vraylar is not FDA approved for pediatric use in:
- Children under 13 years with schizophrenia 1
- Children under 10 years with manic or mixed episodes of bipolar I disorder 1
- Any age children with bipolar depression 1
- Any age children for adjunctive treatment of major depressive disorder 1
Critical Safety Considerations in Pediatric Patients
Black Box Warning for Suicidality
Cariprazine and antidepressant medicines increase the risk of suicidal thoughts or actions in people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed. 1
Monitoring requirements include:
- Close attention to sudden changes in mood, behaviors, thoughts, or feelings 1
- Immediate reporting of new or worsening depression, anxiety, agitation, panic attacks, insomnia, irritability, aggression, or suicidal ideation 1
- Regular follow-up visits, particularly during treatment initiation and dose adjustments 1
Safety and Tolerability Profile in Pediatric Populations
Research data support the FDA approval with favorable safety findings:
- Pharmacokinetic parameters in pediatric patients (ages 10-17) were consistent with those observed in adults, with steady state reached within 1-2 weeks for cariprazine and its active metabolite DCAR, and 4-5 weeks for DDCAR 2
- Most common treatment-related adverse events in pediatric studies included sedation, parkinsonism, tremor, dystonia, and blurred vision 2
- Cariprazine appeared safe and tolerable in children and adolescents with schizophrenia or bipolar disorder in phase I studies 2
- Safety parameters in adolescents (13-17 years) were comparable to adults, with the exception of less insomnia reported in younger patients 3
Dosing Considerations
The FDA-approved adult dose range of 1.5-6 mg may be appropriate for adolescent patients, as pharmacokinetic studies demonstrated dose-proportional increases in systemic exposure from 1.5 to 4.5 mg/day in pediatric populations 2, 3