ABILIFY (Page 12 of 24)

Adult Patients Receiving ABILIFY as Adjunctive Treatment of Major Depressive Disorder

The following findings are based on a pool of two placebo-controlled trials of patients with major depressive disorder in which ABILIFY was administered at doses of 2 mg to 20 mg as adjunctive treatment to continued antidepressant therapy.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions was 6% for adjunctive ABILIFY-treated patients and 2% for adjunctive placebo-treated patients.

Commonly Observed Adverse Reactions

The commonly observed adverse reactions associated with the use of adjunctive ABILIFY in patients with major depressive disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) were: akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision.

Less Common Adverse Reactions in Adult Patients with Major Depressive Disorder

Table 23 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks), including only those adverse reactions that occurred in 2% or more of patients treated with adjunctive ABILIFY (doses ≥2 mg/day) and for which the incidence in patients treated with adjunctive ABILIFY was greater than the incidence in patients treated with adjunctive placebo in the combined dataset.

Table 23:Adverse Reactions in Short-Term, Placebo-Controlled Adjunctive Trials in Patients with Major Depressive Disorder

Percentage of Patients Reporting Reactiona

System Organ Class

ABILIFY + ADT*

Placebo + ADT*

Preferred Term

(n=371)

(n=366)

Eye Disorders

Blurred Vision

6

1

Gastrointestinal Disorders

Constipation

5

2

General Disorders and Administration Site Conditions

Fatigue

8

4

Feeling Jittery

3

1

Infections and Infestations

Upper Respiratory Tract Infection

6

4

Investigations

Weight Increased

3

2

Metabolism and Nutrition Disorders

Increased Appetite

3

2

Musculoskeletal and Connective Tissue Disorders

Arthralgia

4

3

Myalgia

3

1

Nervous System Disorders

Akathisia

25

4

Somnolence

6

4

Tremor

5

4

Sedation

4

2

Dizziness

4

2

Disturbance in Attention

3

1

Extrapyramidal Disorder

2

0

Psychiatric Disorders

Restlessness

12

2

Insomnia

8

2

a Adverse reactions reported by at least 2% of patients treated with adjunctive ABILIFY, except adverse reactions which had an incidence equal to or less than placebo.

* Antidepressant Therapy

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

The following findings are based on a pool of three placebo-controlled trials of patients with agitation associated with schizophrenia or bipolar mania in which ABILIFY injection was administered at doses of 5.25 mg to 15 mg.

Commonly Observed Adverse Reactions

There was one commonly observed adverse reaction (nausea) associated with the use of ABILIFY injection in patients with agitation associated with schizophrenia and bipolar mania (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo).

Less Common Adverse Reactions in Patients with Agitation Associated with Schizophrenia or Bipolar Mania

Table 24 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (24-hour), including only those adverse reactions that occurred in 2% or more of patients treated with ABILIFY injection (doses ≥5.25 mg/day) and for which the incidence in patients treated with ABILIFY injection was greater than the incidence in patients treated with placebo in the combined dataset.

Table 24:Adverse Reactions in Short-Term, Placebo-Controlled Trials in Patients Treated with ABILIFY Injection

Percentage of Patients Reporting Reactiona

System Organ Class

ABILIFY

Placebo

Preferred Term

(n=501)

(n=220)

Cardiac Disorders

Tachycardia

2

<1

Gastrointestinal Disorders

Nausea

9

3

Vomiting

3

1

General Disorders and Administration Site Conditions

Fatigue

2

1

Nervous System Disorders

Headache

12

7

Dizziness

8

5

Somnolence

7

4

Sedation

3

2

Akathisia

2

0

a Adverse reactions reported by at least 2% of patients treated with ABILIFY injection, except adverse reactions which had an incidence equal to or less than placebo.

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