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Reference ID: 2912460 HIGHLIGHTS OF PRESCRIBING INFORMATION valproate (2.2) These highlights do not include all the information needed to use ABILIFY As an adjunct to 2-5 mg 5-10 mg 15 mg safely and effectively. See full prescribing information for ABILIFY. antidepressants for the /day /day /day ® ABILIFY (aripiprazole) Tablets treatment of major ® ABILIFY DISCMELT (aripiprazole) Orally Disintegrating Tablets depressive disorder – adults ® (2.3) ABILIFY (aripiprazole) Oral Solution ® Irritability associated with 2 mg/day 5-10 mg/day 15 mg/day ABILIFY (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY autistic disorder – pediatric Initial U.S. Approval: 2002 patients (2.4) Agitation associated with 9.75 mg /1.3 30 mg/day WARNINGS: INCREASED MORTALITY IN ELDERLY schizophrenia or bipolar mL injected injected PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and mania – adults (2.5) IM IM SUICIDALITY AND ANTIDEPRESSANT DRUGS • Oral formulations: Administer once daily without regard to meals (2) See full prescribing information for complete boxed warning. • IM injection: Wait at least 2 hours between doses. Maximum daily dose • Elderly patients with dementia-related psychosis treated with 30 mg (2.5) antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related ----------------------DOSAGE FORMS AND STRENGTHS--------------------- psychosis. (5.1) • Tablets: 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg (3) • Orally Disintegrating Tablets: 10 mg and 15 mg (3) • Children, adolescents, and young adults taking antidepressants for • Oral Solution: 1 mg/mL (3) major depressive disorder (MDD) and other psychiatric disorders • Injection: 9.75 mg/1.3 mL single-dose vial (3) are at increased risk of suicidal thinking and behavior. (5.2) ------------------------------CONTRAINDICATIONS------------------------------- Known hypersensitivity to ABILIFY (4) ---------------------------RECENT MAJOR CHANGES--------------------------- Indications and Usage, Bipolar I Disorder, ------------------------WARNINGS AND PRECAUTIONS----------------------- Adjunctive Therapy (1.2) 02/2011 • Elderly Patients with Dementia-Related Psychosis: Increased incidence of Dosage and Administration, Bipolar I Disorder, cerebrovascular adverse events (eg, stroke, transient ischemic attack, Adjunctive Therapy (2.2) 02/2011 including fatalities) (5.1) Dosage and Administration, Dosage Adjustment (2.6) 02/2011 • Suicidality and Antidepressants: Increased risk of suicidality in children, ---------------------------INDICATIONS AND USAGE---------------------------- adolescents, and young adults with major depressive disorder (5.2) ABILIFY is an atypical antipsychotic indicated • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation as oral formulations for the: and close monitoring (5.3) Treatment of schizophrenia (1.1) • Tardive Dyskinesia: Discontinue if clinically appropriate (5.4) • Adults: Efficacy was established in four 4-6 week trials and one • Hyperglycemia and Diabetes Mellitus: Monitor glucose regularly in maintenance trial in patients with schizophrenia (14.1) patients with and at risk for diabetes (5.5) • Adolescents (ages 13-17): Efficacy was established in one 6-week trial in • Orthostatic Hypotension: Use with caution in patients with known patients with schizophrenia (14.1) cardiovascular or cerebrovascular disease (5.6) Acute treatment of manic or mixed episodes associated with bipolar I disorder as • Leukopenia, Neutropenia, and Agranulocytosis: have been reported with monotherapy and as an adjunct to lithium or valproate (1.2) antipsychotics including ABILIFY. Patients with a history of a clinically • Adults: Efficacy was established in four 3-week monotherapy trials and significant low white blood cell count (WBC) or a drug-induced one 6-week adjunctive trial in patients with manic or mixed episodes (14.2) leukopenia/neutropenia should have their complete blood count (CBC) • Pediatric Patients (ages 10-17): Efficacy was established in one 4-week monitored frequently during the first few months of therapy and monotherapy trial in patients with manic or mixed episodes (14.2) discontinuation of ABILIFY should be considered at the first sign of a Maintenance treatment of bipolar I disorder, both as monotherapy and as an clinically significant decline in WBC in the absence of other causative adjunct to lithium or valproate (1.2) factors (5.7) • Adults: Efficacy was established in one maintenance monotherapy trial and • Seizures/Convulsions: Use cautiously in patients with a history of seizures in one maintenance adjunctive trial (14.2) or with conditions that lower the seizure threshold (5.8) • Adjunctive treatment of major depressive disorder (MDD) (1.3) • Potential for Cognitive and Motor Impairment: Use caution when • Adults: Efficacy was established in two 6-week trials in patients with MDD operating machinery (5.9) who had an inadequate response to antidepressant therapy during the • Suicide: The possibility of a suicide attempt is inherent in schizophrenia current episode (14.3) and bipolar disorder. Closely supervise high-risk patients (5.11) Treatment of irritability associated with autistic disorder (1.4) -------------------------------ADVERSE REACTIONS------------------------------ • Pediatric Patients (ages 6-17 years): Efficacy was established in two 8­ Commonly observed adverse reactions (incidence ≥5% and at least twice that for week trials in patients with autistic disorder (14.4) placebo) were (6.2): as an injection for the: • Adult patients with schizophrenia: akathisia Acute treatment of agitation associated with schizophrenia or bipolar I disorder • Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal (1.5) disorder, somnolence, and tremor • Adults: Efficacy was established in three 24-hour trials in agitated patients • Adult patients (monotherapy) with bipolar mania: akathisia, sedation, with schizophrenia or manic/mixed episodes of bipolar I disorder (14.5) restlessness, tremor, and extrapyramidal disorder ------------------------DOSAGE AND ADMINISTRATION---------------------- • Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder Initial Recommended Maximum • Pediatric patients (10 to 17 years) with bipolar mania: somnolence, Dose Dose Dose extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary Schizophrenia – adults (2.1) 10-15 mg 10-15 mg 30 mg hypersecretion, and dizziness /day /day /day • Adult patients with major depressive disorder (adjunctive treatment to Schizophrenia – adolescents 2 mg 10 mg 30 mg antidepressant therapy): akathisia, restlessness, insomnia, constipation, (2.1) /day /day /day fatigue, and blurred vision Bipolar mania – adults: 15 mg 15 mg 30 mg • Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, monotherapy (2.2) /day /day /day vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, Bipolar mania – adults: 10-15 mg 15 mg 30 mg salivary hypersecretion, extrapyramidal disorder, and lethargy adjunct to lithium or /day /day /day • Adult patients with agitation associated with schizophrenia or bipolar valproate (2.2) mania: nausea Bipolar mania – pediatric 2 mg 10 mg 30 mg To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers patients: monotherapy or as /day /day /day Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or an adjunct to lithium or www.fda.gov/medwatch Reference ID: 2912460 Page 1 of 80 --------------------------------DRUG INTERACTIONS----------------------------- CYP3A4 inhibitor, the ABILIFY dose should be reduced to one-quarter • Strong CYP3A4 (eg, ketoconazole) or CYP2D6 (eg, fluoxetine) inhibitors (25%) of the usual dose (2.6, 12.3). will increase ABILIFY drug concentrations; reduce ABILIFY dose to one- • CYP3A4 inducers (eg, carbamazepine) will decrease ABILIFY drug half of the usual dose when used concomitantly (2.6, 7.1), except when concentrations; double ABILIFY dose when used concomitantly (2.6, 7.1) used as adjunctive treatment with antidepressants (2.6). If a strong CYP3A4 inhibitor and strong CYP2D6 inhibitor are co-administered or a See 17 for PATIENT COUNSELING INFORMATION and Medication known CYP2D6 poor metabolizer is receiving a concomitant strong Guide Revised: 02/2011 Reference ID: 2912460 Page 2 of 80 FULL PRESCRIBING INFORMATION: CONTENTS* WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS 7.1 Potential for Other Drugs to Affect ABILIFY WITH DEMENTIA-RELATED PSYCHOSIS AND SUICIDALITY 7.2 Potential for ABILIFY to Affect Other Drugs AND ANTIDEPRESSANT DRUGS 7.3 Drugs Having No Clinically Important Interactions with 1 INDICATIONS AND USAGE ABILIFY 1.1 Schizophrenia 8 USE IN SPECIFIC POPULATIONS 1.2 Bipolar I Disorder 8.1 Pregnancy 1.3 Adjunctive Treatment of Major Depressive Disorder 8.2 Labor and Delive r y 1.4 Irritability Associated with Autistic Disorder 8.3 Nursing Mothers 1.5 Agitation Associated with Schizophrenia or Bipolar Mania 8.4 Pediatric Use 1.6 Special Considerations in Treating Pediatric 8.5 Geriatric Use Schizophrenia, Bipolar I Disorder, and Irritability 8.6 Renal Impairment Associated with Autistic Disorder 8.7 Hepatic Impairment 2 DOSAGE AND ADM INISTRATION 8.8 Gender 2.1 Schizophrenia 8.9 Race 2.2 Bipolar I Disorder 8.10 Smoking 2.3 Adjunctive Treatment of Major Depressive Disorder 9 DRUG ABUSE AND DEPENDENCE 2.4 Irritability Associated with Autistic Disorder 9.1 Controlled Substance 2.5 Agitation Associated with Schizophrenia or Bipolar Mania 9.2
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