Fanapt (Iloperidone) FDA Approval Age
Fanapt (iloperidone) is only approved for use in adults (18 years and older) with schizophrenia. There is no FDA approval for its use in children or adolescents.
Evidence on Antipsychotic Approvals
- The available evidence does not indicate that Fanapt (iloperidone) has received FDA approval for use in children or adolescents with schizophrenia 1
- A randomized trial of iloperidone (REPRIEVE study) evaluated its effectiveness for prevention of relapse in schizophrenia, but only included adult subjects 1
- In contrast, some other antipsychotics have specific pediatric approvals:
Clinical Considerations for Antipsychotic Use in Youth
- Treatment of early-onset schizophrenia (occurring between 13-17 years) requires careful medication selection, as only specific antipsychotics have been studied and approved for this population 5
- When treating adolescents with schizophrenia, clinicians should prioritize medications with established safety and efficacy in this age group 4
- The pattern of response to antipsychotics in youth appears similar to that in adults, but youth with early-onset schizophrenia may be less likely to respond adequately to medication therapy 4
Safety Considerations
- The long-term use of antipsychotics in early-onset schizophrenia has not been extensively studied, making it important to use FDA-approved medications when possible 4
- Atypical antipsychotics approved for adolescents have demonstrated specific safety profiles that have been evaluated in this population:
- Aripiprazole was generally well tolerated in adolescents with schizophrenia in clinical trials, with most adverse events being mild to moderate in severity 3
- Weight gain varies among antipsychotics, with aripiprazole showing less significant weight gain compared to olanzapine in adolescent populations 6
Practical Guidance
- When treating adolescents with schizophrenia, clinicians should first consider FDA-approved options for this age group before considering off-label alternatives 4
- For patients under 18 years of age requiring antipsychotic treatment for schizophrenia, FDA-approved options include aripiprazole (13-17 years) and other specifically approved medications 2, 3
- Baseline and follow-up assessments, including physical examination and laboratory tests, are essential when initiating antipsychotic treatment in adolescents 4
In summary, Fanapt (iloperidone) is only approved for adult patients with schizophrenia (18 years and older). For adolescent patients with schizophrenia, clinicians should consider FDA-approved options such as aripiprazole, which has demonstrated efficacy and safety in this population.