1 INDICATIONS AND USAGE
ABILIFY is an atypical antipsychotic indicated as oral formulations for the:
Treatment of schizophrenia (1.1)
Adults: Efficacy was established in four 4-6 week trials and one maintenance trial in patients with schizophrenia (14.1)
Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia (14.1)
Acute treatment of manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or valproate (1.2)
Adults: Efficacy was established in four 3-week monotherapy trials and one 6-week adjunctive trial in patients with manic or mixed episodes (14.2)
Pediatric Patients (ages 10-17): Efficacy was established in one 4-week monotherapy trial in patients with manic or mixed episodes (14.2)
Maintenance treatment of bipolar I disorder (1.2)
Adults: Efficacy was established in one maintenance trial (14.2)
Adjunctive treatment of major depressive disorder (MDD) (1.3)
Adults: Efficacy was established in two 6-week trials in patients with MDD who had an inadequate response to antidepressant therapy during the current episode (14.3)
Treatment of irritability associated with autistic disorder (1.4)
Pediatric Patients (ages 6-17 years): Efficacy was established in two 8-week trials in patients with autistic disorder (14.4)
as an injection for the:
Acute treatment of agitation associated with schizophrenia or bipolar I disorder (1.5)
Adults: Efficacy was established in three 24-hour trials in agitated patients with schizophrenia or manic/mixed episodes of bipolar I disorder
(14.5)
1.1 Schizophrenia
ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). Maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see CLINICAL STUDIES (14.1)].
1.2 Bipolar I Disorder
Monotherapy
ABILIFY is indicated for the acute and maintenance treatment of manic and mixed episodes associated with bipolar I disorder. Efficacy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). Maintenance efficacy was demonstrated in a monotherapy trial in adults and can be extrapolated to pediatric patients (10 to 17 years) [see CLINICAL STUDIES (14.2)].
Adjunctive Therapy
ABILIFY is indicated as an adjunctive therapy to either lithium or valproate for the acute treatment of manic and mixed episodes associated with bipolar I disorder. Efficacy was established in one 6-week adjunctive trial in adults and can be extrapolated to pediatric patients (10 to 17 years) [see CLINICAL STUDIES (14.2)].
1.3 Adjunctive Treatment of Major Depressive Disorder
ABILIFY is indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). Efficacy was established in two 6-week trials in adults with MDD who had an inadequate response to antidepressant therapy during the current episode [see CLINICAL STUDIES (14.3)].
1.4 Irritability Associated with Autistic Disorder
ABILIFY is indicated for the treatment of irritability associated with autistic disorder. Efficacy was established in two 8-week trials in pediatric patients (aged 6 to 17 years) with irritability associated with autistic disorder (including symptoms of aggression towards others, deliberate self-injuriousness, temper tantrums, and quickly changing moods) [see CLINICAL STUDIES (14.4)].
1.5 Agitation Associated with Schizophrenia or Bipolar Mania
ABILIFY Injection is indicated for the acute treatment of agitation associated with schizophrenia or bipolar disorder, manic or mixed. "Psychomotor agitation" is defined in DSM-IV as "excessive motor activity associated with a feeling of inner tension". Patients experiencing agitation often manifest behaviors that interfere with their diagnosis and care (eg, threatening behaviors, escalating or urgently distressing behavior, or self-exhausting behavior), leading clinicians to the use of intramuscular antipsychotic medications to achieve immediate control of the agitation. Efficacy was established in three short-term (24-hour) trials in adults [see CLINICAL STUDIES (14.5)].
1.6 Special Considerations in Treating Pediatric Schizophrenia, Bipolar I Disorder, and Irritability Associated with Autistic Disorder
Psychiatric disorders in children and adolescents are often serious mental disorders with variable symptom profiles that are not always congruent with adult diagnostic criteria. It is recommended that psychotropic medication therapy for pediatric patients only be initiated after a thorough diagnostic evaluation has been conducted and careful consideration given to the risks associated with medication treatment. Medication treatment for pediatric patients with schizophrenia, bipolar I disorder, and irritability associated with autistic disorder is indicated as part of a total treatment program that often includes psychological, educational, and social interventions.