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Abilify (Aripiprazole) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Schizophrenia

ABILIFY is indicated for the treatment of schizophrenia. The efficacy of ABILIFY in the treatment of schizophrenia was established in short-term (4- and 6-week) controlled trials of schizophrenic inpatients (see CLINICAL PHARMACOLOGY: Clinical Studies).

The efficacy of ABILIFY in maintaining stability in patients with schizophrenia who had been symptomatically stable on other antipsychotic medications for periods of 3 months or longer, were discontinued from those other medications, and were then administered ABILIFY 15 mg/day and observed for relapse during a period of up to 26 weeks was demonstrated in a placebo-controlled trial (see CLINICAL PHARMACOLOGY: Clinical Studies). The physician who elects to use ABILIFY for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION).

Bipolar Disorder

ABILIFY is indicated for the treatment of acute manic and mixed episodes associated with Bipolar Disorder.

The efficacy of ABILIFY was established in two placebo-controlled trials (3 week) of inpatients with DSM-IV criteria for Bipolar I Disorder who were experiencing an acute manic or mixed episode with or without psychotic features (see CLINICAL PHARMACOLOGY: Clinical Studies).

The efficacy of ABILIFY in maintaining efficacy in patients with Bipolar I Disorder with a recent manic or mixed episode who had been stabilized and then maintained for at least 6 weeks, was demonstrated in a double-blind, placebo-controlled trial. Prior to entering the double-blind, randomization phase of this trial, patients were clinically stabilized and maintained their stability for 6 consecutive weeks on ABILIFY. Following this 6-week maintenance phase, patients were randomized to either placebo or ABILIFY and monitored for relapse (see CLINICAL PHARMACOLOGY: Clinical Studies). 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 patient (see DOSAGE AND ADMINISTRATION).

Agitation Associated with Schizophrenia or Bipolar Mania

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.

The efficacy of ABILIFY Injection for the treatment of agitation associated with schizophrenia or Bipolar I Disorder was established in three short-term (24-hour), placebo-controlled trials in agitated inpatients with schizophrenia or Bipolar I Disorder (manic or mixed episodes) (see CLINICAL PHARMACOLOGY: Clinical Studies).

DOSAGE AND ADMINISTRATION

ORAL

Schizophrenia

Usual Dose

The recommended starting and target dose for ABILIFY is 10 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 to 30 mg/day, when administered as the tablet formulation; however, doses higher than 10 or 15 mg/day were not more effective than 10 or 15 mg/day. Dosage increases should not be made before 2 weeks, the time needed to achieve steady state.

Dosage in Special Populations

Dosage adjustments are not routinely indicated on the basis of age, gender, race, or renal or hepatic impairment status (see CLINICAL PHARMACOLOGY: Special Populations).

Dosage adjustment for patients taking aripiprazole concomitantly with potential CYP3A4 inhibitors: When concomitant administration of ketoconazole with aripiprazole occurs, aripiprazole dose should be reduced to one-half of the usual dose. When the CYP3A4 inhibitor is withdrawn from the combination therapy, aripiprazole dose should then be increased.

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, aripiprazole dose should then be increased.

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 (to 20 or 30 mg). Additional dose increases should be based on clinical evaluation. When carbamazepine is withdrawn from the combination therapy, the aripiprazole dose should be reduced to 10 to 15 mg.

Maintenance Therapy

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, demonstrated a benefit of such maintenance treatment (see CLINICAL PHARMACOLOGY: Clinical Studies). 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.

Bipolar Disorder

Usual Dose

In clinical trials, the starting dose was 30 mg given once a day. 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.

Dosage in Special Populations

See Dosage in Special Populations under DOSAGE AND ADMINISTRATION: Schizophrenia.

Maintenance Therapy

While there is no body of evidence available to answer the question of how long a patient treated with aripiprazole should remain on it, 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 PHARMACOLOGY: 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 (ie, beyond 6 weeks).

Oral Solution

The oral solution can be given on a mg-per-mg basis in place of the 5-, 10-, 15-, or 20-mg tablet strengths. Solution doses can be substituted for the tablet doses on a mg-per-mg basis up to 25 mg of the tablet. Patients receiving 30-mg tablets should receive 25 mg of the solution (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

Directions for Use of ABILIFY DISCMELT Orally Disintegrating Tablets

Patients should be told the following:

Do not open the blister until ready to administer. For single tablet removal, open the package and peel back the foil on the blister to expose the tablet. Do not push the tablet through the foil because this could damage the tablet. Immediately upon opening the blister, using dry hands, remove the tablet and place the entire ABILIFY DISCMELT orally disintegrating tablet on the tongue. Tablet disintegration occurs rapidly in saliva. It is recommended that ABILIFY DISCMELT be taken without liquid. However, if needed, it can be taken with liquid. Do not attempt to split the tablet.

INTRAMUSCULAR INJECTION

Agitation Associated with Schizophrenia or Bipolar Mania

Usual Dose

The efficacy of aripiprazole injection in controlling agitation in these disorders was demonstrated in a dose range of 5.25 mg to 15 mg. The recommended dose in these patients is 9.75 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. Also, 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.

If ongoing aripiprazole therapy is clinically indicated, oral aripiprazole in a range of 10 mg to 30 mg/day should replace aripiprazole injection as soon as possible (see PHARMACOLOGY and DOSAGE AND ADMINISTRATION: Schizophrenia or Bipolar Disorder).

Administration of ABILIFY Injection

To administer ABILIFY Injection, draw up the required volume of solution into the syringe as shown in Table 6. Discard any unused portion.

Table 6: ABILIFY Injection Dosing Recommendations
Single-DoseRequired Volume of Solution
5.25 mg0.7 mL
9.75 mg1.3 mL
15 mg2 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.

Dosage in Special Populations

See Dosage in Special Populations under DOSAGE AND ADMINISTRATION: Schizophrenia.

HOW SUPPLIED

ABILIFY® (aripiprazole) Tablets have markings on one side and are available in the strengths and packages listed in Table 7.

Table 7: ABILIFY Tablet Presentations
Tablet
Strength
Tablet
Color/Shape
Tablet
Markings
Pack
Size
NDC
Code
2 mggreen
modified rectangle
"A-006"
and "2"
Bottle of 30

Blister of 100
59148-006-13

59148-006-35
5 mgblue
modified rectangle
"A-007"
and "5"
Bottle of 30

Blister of 100
59148-007-13

59148-007-35
10 mgpink
modified rectangle
"A-008"
and "10"
Bottle of 30

Blister of 100
59148-008-13

59148-008-35
15 mgyellow
round
"A-009"
and "15"
Bottle of 30

Blister of 100
59148-009-13

59148-009-35
20 mgwhite
round
"A-010"
and "20"
Bottle of 30

Blister of 100
59148-010-13

59148-010-35
30 mgpink
round
"A-011"
and "30"
Bottle of 30

Blister of 100
59148-011-13

59148-011-35

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 8.

Table 8: ABILIFY DISCMELT Orally Disintegrating Tablet Presentations
Tablet
Strength
Tablet
Color
Tablet
Markings
Pack
Size
NDC
Code
10 mgpink (with
scattered specks)
"A" and "640"
"10"
Blister of 3059148-640-23
15 mgyellow (with
scattered specks)
"A" and "641"
"15"
Blister of 3059148-641-23

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

US Patent Nos: 5,006,528; 6,977,257; and 7,115,587

© 2006, Otsuka Pharmaceutical Co, Ltd, Tokyo, 101-8535 Japan

1216978A2
191707A8
1174/11-06

Rev November 2006

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