ABILIFY (Page 2 of 16)

2.2 Bipolar I Disorder

Adults

Dose Selection: The recommended starting and target dose is 15 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. ABILIFY may be given without regard to meals. The dose may be increased to 30 mg/day based on clinical response. The safety of doses above 30 mg/day has not been evaluated in clinical trials [see CLINICAL STUDIES (14.2)].

Maintenance Treatment: Maintenance of efficacy in bipolar I disorder was demonstrated in a trial involving patients who had been symptomatically stable on ABILIFY Tablets (15 mg/day or 30 mg/day, as monotherapy) for at least 6 consecutive weeks. These patients were discontinued from those medications and randomized to either ABILIFY, at the same dose they were stabilized on, or placebo, and observed for relapse [see CLINICAL STUDIES (14.2)]. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

Pediatric Patients

Dose Selection: The efficacy of ABILIFY has been established in the treatment of pediatric patients 10 to 17 years of age with bipolar I disorder at doses of 10 mg/day or 30 mg/day. The recommended target dose of ABILIFY is 10 mg/day, as monotherapy or as adjunctive therapy with lithium or valproate. The starting daily dose of the tablet formulation in these patients was 2 mg/day, which was titrated to 5 mg/day after 2 days and to the target dose of 10 mg/day after 2 additional days. Subsequent dose increases should be administered in 5 mg/day increments. ABILIFY can be administered without regard to meals. [See CLINICAL STUDIES (14.2).]

Maintenance Treatment: The efficacy of ABILIFY for the maintenance treatment of bipolar I disorder in the pediatric population has not been evaluated. While there is no body of evidence available to answer the question of how long the pediatric patient treated with ABILIFY should be maintained, maintenance efficacy can be extrapolated from adult data along with comparisons of aripiprazole pharmacokinetic parameters in adult and pediatric patients. Thus, responding patients may be considered for continued treatment beyond the acute response at the lowest dose required to maintain remission. Patients should be periodically reassessed to determine the continued need for maintenance treatment.

2.3 Adjunctive Treatment of Major Depressive Disorder

Adults

Dose Selection: The recommended starting dose for ABILIFY as adjunctive treatment for patients already taking an antidepressant is 2 mg/day to 5 mg/day. The efficacy of ABILIFY as an adjunctive therapy for major depressive disorder was established within a dose range of 2 mg/day to 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES (14.3)].

Maintenance Treatment: The efficacy of ABILIFY for the adjunctive maintenance treatment of major depressive disorder has not been evaluated. While there is no body of evidence available to answer the question of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment.

2.4 Irritability Associated with Autistic Disorder

Pediatric Patients

Dose Selection: The efficacy of aripiprazole has been established in the treatment of pediatric patients 6 to 17 years of age with irritability associated with autistic disorder at doses of 5 mg/day to 15 mg/day. The dosage of ABILIFY should be individualized according to tolerability and response.

Dosing should be initiated at 2 mg/day. The dose should be increased to 5 mg/day, with subsequent increases to 10 mg/day or 15 mg/day if needed. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week [see CLINICAL STUDIES (14.4)].

Maintenance Treatment: The efficacy of ABILIFY for the maintenance treatment of irritability associated with autistic disorder has not been evaluated. While there is no body of evidence available to answer the question of how long the patient treated with ABILIFY should be maintained, patients should be periodically reassessed to determine the continued need for maintenance treatment.

2.5 Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)

Adults

Dose Selection: The recommended dose in these patients is 9.75 mg. The effectiveness of aripiprazole injection in controlling agitation in schizophrenia and bipolar mania was demonstrated over a dose range of 5.25 mg to 15 mg. No additional benefit was demonstrated for 15 mg compared to 9.75 mg. A lower dose of 5.25 mg may be considered when clinical factors warrant. If agitation warranting a second dose persists following the initial dose, cumulative doses up to a total of 30 mg/day may be given. However, the efficacy of repeated doses of aripiprazole injection in agitated patients has not been systematically evaluated in controlled clinical trials. The safety of total daily doses greater than 30 mg or injections given more frequently than every 2 hours have not been adequately evaluated in clinical trials [see CLINICAL STUDIES (14.5)].

If ongoing aripiprazole therapy is clinically indicated, oral aripiprazole in a range of 10 mg/day to 30 mg/day should replace aripiprazole injection as soon as possible [see DOSAGE AND ADMINISTRATION (2.1 and 2.2)].

Administration of ABILIFY Injection

To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 1. Discard any unused portion.

Table 1: ABILIFY Injection Dosing Recommendations
Single-Dose Required Volume of Solution
5.25 mg 0.7 mL
9.75 mg 1.3 mL
15 mg 2 mL

ABILIFY Injection is intended for intramuscular use only. Do not administer intravenously or subcutaneously. Inject slowly, deep into the muscle mass.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

2.6 Dosage Adjustment

Dosage adjustments in adults are not routinely indicated on the basis of age, gender, race, or renal or hepatic impairment status [see USE IN SPECIFIC POPULATIONS (8.48.10)].

Dosage adjustment for patients taking aripiprazole concomitantly with strong CYP3A4 inhibitors:
When concomitant administration of aripiprazole with strong CYP3A4 inhibitors such as ketoconazole or clarithromycin is indicated, the aripiprazole dose should be reduced to one-half the usual dose. When the CYP3A4 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should then be increased [see DRUG INTERACTIONS (7.1)].
Dosage adjustment for patients taking aripiprazole concomitantly with potential CYP2D6 inhibitors:
When concomitant administration of potential CYP2D6 inhibitors such as quinidine, fluoxetine, or paroxetine with aripiprazole occurs, aripiprazole dose should be reduced at least to one-half of its normal dose. When the CYP2D6 inhibitor is withdrawn from the combination therapy, the aripiprazole dose should then be increased [see DRUG INTERACTIONS (7.1)]. When adjunctive ABILIFY is administered to patients with major depressive disorder, ABILIFY should be administered without dosage adjustment as specified in DOSAGE AND ADMINISTRATION (2.3).
Dosage adjustment for patients taking potential CYP3A4 inducers:
When a potential CYP3A4 inducer such as carbamazepine is added to aripiprazole therapy, the aripiprazole dose should be doubled. Additional dose increases should be based on clinical evaluation. When the CYP3A4 inducer is withdrawn from the combination therapy, the aripiprazole dose should be reduced to 10 mg to 15 mg [see DRUG INTERACTIONS (7.1)].

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