Brand Name: Abilify
Generic Name: aripiprazole
Abilify (aripiprazole) is an antipsychotic medication used in treatment of bipolar
mania and schizophrenia. Detailed info on uses, dosage and side-effects of Abilify below.
Abilify Patient Information Sheet
Contents:
Full Prescribing Info Abilify Page 1
Full Prescribing Info Abilify Page 2
Full Prescribing Info Abilify Page 3
1 Indications and Usage
1.1 Indications and Usage - Schizophrenia
1.2 Indications and Usage - Bipolar Disorder
1.3 Indications and Usage - Adjunctive Treatment of Major Depressive Disorder
1.4 Indications and Usage - Agitation Associated with Schizophrenia or Bipolar Mania
2. Dosage and Administration
3 Forms and Strengths
4 Contraindications
5 Warnings and Precautions
6 Adverse Reactions
7 Drug Interactions
8 Use in Specific Populations
9 Drug Abuse and Dependence
10 Overdosage
11 Description
12 Clinical Pharmacology
13 Nonclinical Toxicology
14 Clinical Studies
16 How Supplied Storage and Handling
17 Patient Counseling Information
FULL PRESCRIBING INFORMATION
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WARNINGS: INCREASED MORTALITY IN ELDERLY PATIENTS
WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDALITY AND
ANTIDEPRESSANT DRUGS
Elderly patients with dementia-related psychosis treated with antipsychotic
drugs are at an increased risk of death. Analyses of seventeen placebocontrolled
trials (modal duration of 10 weeks), largely in patients taking
atypical antipsychotic drugs, revealed a risk of death in drug-treated
patients of between 1.6 to 1.7 times the risk of death in placebo-treated
patients. Over the course of a typical 10-week controlled trial, the rate of
death in drug-treated patients was about 4.5%, compared to a rate of about
2.6% in the placebo group. Although the causes of death were varied, most
of the deaths appeared to be either cardiovascular (eg, heart failure, sudden
death) or infectious (eg, pneumonia) in nature. Observational studies
suggest that, similar to atypical antipsychotic drugs, treatment with
conventional antipsychotic drugs may increase mortality. The extent to
which the findings of increased mortality in observational studies may be
attributed to the antipsychotic drug as opposed to some characteristic(s) of
the patients is not clear. ABILIFY (aripiprazole) is not approved for the
treatment of patients with dementia-related psychosis [see Warnings and
Precautions (5.1)].
Antidepressants increased the risk compared to placebo of suicidal
thinking and behavior (suicidality) in children, adolescents, and young
adults in short-term studies of Major Depressive Disorder (MDD) and other
psychiatric disorders. Anyone considering the use of adjunctive ABILIFY or
any other antidepressant in a child, adolescent, or young adult must
balance this risk with the clinical need. Short-term studies did not show
an increase in the risk of suicidality with antidepressants compared to
placebo in adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in adults aged 65 and older.
Depression and certain other psychiatric disorders are themselves
associated with increases in the risk of suicide. Patients of all ages who are
started on antidepressant therapy should be monitored appropriately and
observed closely for clinical worsening, suicidality, or unusual changes in
behavior. Families and caregivers should be advised of the need for close
observation and communication with the prescriber. ABILIFY is not
approved for use in pediatric patients with depression [see Warnings and
Precautions (5.2)].
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ABILIFY is indicated for acute and maintenance treatment of Schizophrenia in adults and in
adolescents 13 to 17 years of age [see Clinical Studies (14.1)].
Monotherapy
ABILIFY is indicated for acute and maintenance treatment of manic and mixed episodes
associated with Bipolar I Disorder with or without psychotic features in adults and in pediatric
patients 10 to 17 years of age [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 with or without
psychotic features in adults and in pediatric patients 10 to 17 years of age [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 acute treatment
of Major Depressive Disorder in adults [see Clinical Studies (14.3)].
1.4 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 in adults. “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 (14.4)].
2 Dosage and Administration
2.1 Schizophrenia
Adults
The recommended starting and target dose for ABILIFY 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 (14.1)].
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 (aripiprazole) can be administered
without regard to meals [see Clinical Studies (14.1)].
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 (14.1)].
Patients should be periodically reassessed to determine the need for maintenance treatment.
Adolescents
The efficacy of ABILIFY for the maintenance treatment of Schizophrenia in the pediatric
population has not been evaluated. While there is no body of evidence available to answer the
question of how long the adolescent 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, it is generally
recommended that responding patients be continued beyond the acute response, but at the
lowest dose needed to maintain remission. Patients should be periodically reassessed to
determine the need for maintenance treatment.
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.
2.2 Bipolar Disorder
Usual Dose for Acute Treatment
Adults
The recommended starting and target dose is 15 mg as monotherapy or as adjunctive therapy
with lithium or valproate given once a day, without regard to meals. The dose can 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)].
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, 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 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, whether used as monotherapy or as adjunctive
therapy, adult patients with Bipolar I Disorder who had been symptomatically stable on ABILIFY
Tablets (15 mg/day or 30 mg/day as monotherapy 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 (14.2)]. 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. 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, it is generally
recommended that responding patients be continued beyond the acute response, but at the
lowest dose needed to maintain remission. Patients should be periodically reassessed to
determine the need for maintenance treatment.
2.3 Adjunctive Treatment of Major Depressive Disorder
Usual Dose for Acute Treatment
Adults
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)].
Pediatric Patients
The efficacy of ABILIFY (aripiprazole) for the adjunctive treatment of Major Depressive Disorder
in the pediatric population has not been evaluated.
Maintenance Therapy
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 need for maintenance treatment.
2.4 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 (14.4)].
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.
| Table1: 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.
Pediatric Patients
ABILIFY Intramuscular Injection has not been evaluated in pediatric patients.
2.5 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 (8.4-8.10)].
- 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)].
2.6 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 (12.3)].
2.7 Dosing of Orally Disintegrating Tablets
The dosing for ABILIFY Orally Disintegrating Tablets is the same as for the oral tablets [see
Dosage and Administration (2.1, 2.2, and 2.3)].
3 FORMS AND STRENGTHS
ABILIFY® (aripiprazole) Tablets are available as described in Table 2.
| Table 2: ABILIFY Table
Presentations |
| Table Strength |
Tablet Color/Shape |
Tablet Markings |
| 2 mg |
green modified rectangle |
"A-006" and "2" |
| 5 mg |
blue modified rectangle |
“A-007” and “5” |
| 10 mg |
pink modified rectangle |
“A-008” and “10” |
| 15 mg |
yellow round |
“A-009” and “15” |
| 20 mg |
white round |
“A-010” and “20” |
| 30 mg |
pink round |
“A-011” and “30” |
ABILIFY DISCMELT® (aripiprazole) Orally Disintegrating Tablets are available as described in Table 3.
| Table 3: ABILIFY DISCMELT Orally Disintegrating Tablet Presentations |
| Table Strength |
Tablet Color/Shape |
Tablet Markings |
| 10 mg |
pink (with scattered specks) round |
“A” and “640”
“10” |
| 15 mg |
yellow (with scattered specks) round |
“A” and “641” |
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.
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Reviewed: 10/2008
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