Schizophrenia

Adults

ABILIFY is indicated for acute and maintenance treatment of Schizophrenia [see Clinical Studies].

Adolescents

ABILIFY is indicated for the treatment of Schizophrenia in adolescents 13 to 17 years of age [see Clinical Studies].

Bipolar Disorder

Adults

ABILIFY is indicated for acute and maintenance treatment of manic and mixed episodes associated with Bipolar I Disorder with or without psychotic features [see Clinical Studies].

Pediatric Patients

ABILIFY is indicated for the acute treatment of manic and mixed episodes associated with Bipolar Disorder with or without psychotic features in pediatric patients 10 to 17 years of age [see Clinical Studies].

Adjunctive Treatment of Major Depressive Disorder

Adults

ABILIFY is indicated for use as an adjunctive treatment to antidepressants for Major Depressive Disorder [see Clinical Studies].

Agitation Associated with Schizophrenia or Bipolar Mania

Adults

ABILIFY Injection is indicated for the 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 [see Clinical Studies].

Schizophrenia Usual Dose

Adults

The recommended starting and target dose for ABILIFY (aripiprazole) is 10 mg/day or 15 mg/day administered on a once-a-day schedule without regard to meals. ABILIFY has been systematically evaluated and shown to be effective in a dose range of 10 mg/day to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 mg/day or 15 mg/day were not more effective than 10 mg/day or 15 mg/day. Dosage increases should not be made before 2 weeks, the time needed to achieve steady-state [see Clinical Studies].

Adolescents

The recommended target dose of ABILIFY is 10 mg/day. Aripiprazole was studied in pediatric patients 13 to 17 years of age with Schizophrenia at daily doses of 10 mg and 30 mg. The starting daily dose of the tablet formulation in these patients was 2 mg, which was titrated to 5 mg after 2 days and to the target dose of 10 mg after 2 additional days. Subsequent dose increases should be administered in 5 mg increments. The 30 mg/day dose was not shown to be more efficacious than the 10 mg/day dose. ABILIFY can be administered without regard to meals [see Clinical Studies].

Maintenance Therapy

Adults

While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, systematic evaluation of patients with Schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer, were discontinued from those medications, and were then administered ABILIFY 15 mg/day and observed for relapse during a period of up to 26 weeks, has demonstrated a benefit of such maintenance treatment [see Clinical Studies] Patients should be periodically reassessed to determine the need for maintenance treatment.

Pediatric Patients

The efficacy of ABILIFY for the maintenance treatment of Schizophrenia in the pediatric population has not been evaluated.

Switching from Other Antipsychotics

There are no systematically collected data to specifically address switching patients with Schizophrenia from other antipsychotics to ABILIFY or concerning concomitant administration with other antipsychotics. While immediate discontinuation of the previous antipsychotic treatment may be acceptable for some patients with Schizophrenia, more gradual discontinuation may be most appropriate for others. In all cases, the period of overlapping antipsychotic administration should be minimized.

Bipolar Disorder

Usual Dose

Adults

In clinical trials, the starting dose was 30 mg given once a day, without regard to meals. A dose of 30 mg/day was found to be effective when administered as the tablet formulation. Approximately 15% of patients had their dose decreased to 15 mg based on assessment of tolerability. The safety of doses above 30 mg/day has not been evaluated in clinical trials [see Clinical Studies].

Pediatric Patients

The efficacy of aripiprazole 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. 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. ]

Maintenance Therapy

Adults

While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, adult patients with Bipolar I Disorder who had been symptomatically stable on ABILIFY Tablets (15 mg/day or 30 mg/day with a starting dose of 30 mg/day) for at least 6 consecutive weeks and then randomized to ABILIFY Tablets (15 mg/day or 30 mg/day) or placebo and monitored for relapse, demonstrated a benefit of such maintenance treatment [see Clinical Studies]. While it is generally agreed that pharmacological treatment beyond an acute response in Mania is desirable, both for maintenance of the initial response and for prevention of new manic episodes, there are no systematically obtained data to support the use of aripiprazole in such longer-term treatment (beyond 6 weeks). Physicians who elect to use ABILIFY for extended periods, that is, longer than 6 weeks, should periodically re-evaluate the long-term usefulness of the drug for the individual.

Pediatric Patients

The efficacy of ABILIFY for the maintenance treatment of Bipolar I Disorder in the pediatric population has not been evaluated.

Adjunctive Treatment of Major Depressive Disorder

Usual Dose

Adults

The recommended starting dose for ABILIFY (aripiprazole) 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/dayto 15 mg/day. Dose adjustments of up to 5 mg/day should occur gradually, at intervals of no less than 1 week. The long-term efficacy of ABILIFY for the adjunctive treatment of Major Depressive Disorder has not been established [see Clinical Studies].

Pediatric Patients

The efficacy of ABILIFY for the adjunctive treatment of Major Depressive Disorder in the pediatric population has not been evaluated.

Agitation Associated with Schizophrenia or Bipolar Mania (Intramuscular Injection)

Usual Dose

Adults

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].

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].

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

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.

Pediatric Patients

ABILIFY Intramuscular Injection has not been evaluated in pediatric patients.

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].

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].

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]. When adjunctive ABILIFY is administered to patients with Major Depressive Disorder, ABILIFY should be administered without dosage adjustment as specified in DOSAGE AND ADMINISTRATION.

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].

Dosing of Oral Solution

The oral solution can be substituted for tablets on a mg-per-mg basis up to the 25 mg dose level. Patients receiving 30 mg tablets should receive 25 mg of the solution [see CLINICAL PHARMACOLOGY].

Dosing of Orally Disintegrating Tablets

The dosing for ABILIFY Orally Disintegrating Tablets is the same as for the oral tablets [see DOSAGE AND ADMINISTRATION].

Dosage Forms And Strengths

ABILIFY®(aripiprazole) Tablets are available as described in Table 2.

Table 2: ABILIFY Tablet Presentations

ABILIFY® DISCMELT™(aripiprazole) Orally Disintegrating Tablets are available as described in Table 3.

Table 3: ABILIFY DISCMELTOrally Disintegrating Tablet Presentations

ABILIFY® (aripiprazole) Oral Solution (1 mg/mL) is a clear, colorless to light yellow solution, supplied in child-resistant bottles along with a calibrated oral dosing cup.

ABILIFY® (aripiprazole) Injection for Intramuscular Use is a clear, colorless solution available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials.

ABILIFY® (aripiprazole) Tablets have markings on one side and are available in the strengths and packages listed in Table 13.

Table 13: ABILIFY Tablet Presentations

ABILIFY® DISCMELT™ (aripiprazole) Orally Disintegrating Tablets are round tablets with markings on either side. ABILIFY DISCMELT is available in the strengths and packages listed in Table 14.

Table 14: ABILIFY DISCMELT Orally Disintegrating Tablet Presentations

ABILIFY®(aripiprazole) Oral Solution (1 mg/mL) is supplied in child-resistant bottles along with a calibrated oral dosing cup. ABILIFY Oral Solution is available as follows:

150 mL bottle NDC 59148-013-15

ABILIFY®(aripiprazole) Injection for intramuscular use is available as a ready-to-use, 9.75 mg/1.3 mL (7.5 mg/mL) solution in clear, Type 1 glass vials as follows:

9.75 mg/1.3 mL single-dose vial NDC 59148-016-65

Storage

Tablets

Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature].

Oral Solution

Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Opened bottles of ABILIFY Oral Solution can be used for up to 6 months after opening, but not beyond the expiration date on the bottle. The bottle and its contents should be discarded after the expiration date.

Injection

Store at 25° C (77° F); excursions permitted between 15° C to 30° C (59° F to 86° F) [see USP Controlled Room Temperature]. Protect from light by storing in the original container. Retain in carton until time of use.

Tablets manufactured by Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan or Bristol-Myers Squibb Company, Princeton, NJ 08543 USA

Orally Disintegrating Tablets, Oral Solution, and Injection: Manufactured by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Distributed and marketed by Otsuka America Pharmaceutical, Inc, Rockville, MD 20850 USA. Marketed by Bristol-Myers Squibb Company, Princeton, NJ 08543 USA. Rev February 2008. Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan. FDA rev date: 2/27/2008

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