ABILIFY (Page 11 of 24)

Pediatric Patients (6 to 17 years) with Autistic Disorder

The following findings are based on two 8-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 15 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (6 to 17 years) was 10% and 8%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with autistic disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 20.

Table 20:Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 17 years) with Autistic Disorder Treated with Oral ABILIFY

Percentage of Patients Reporting Reaction

ABILIFY

Placebo

Preferred Term

(n=212)

(n=101)

Sedation

21

4

Fatigue

17

2

Vomiting

14

7

Somnolence

10

4

Tremor

10

0

Pyrexia

9

1

Drooling

9

0

Decreased Appetite

7

2

Salivary Hypersecretion

6

1

Extrapyramidal Disorder

6

0

Lethargy

5

0

Pediatric Patients (6 to 18 years) with Tourette’s Disorder

The following findings are based on one 8-week and one 10-week, placebo-controlled trials in which oral ABILIFY was administered in doses of 2 to 20 mg/day.

Adverse Reactions Associated with Discontinuation of Treatment

The incidence of discontinuation due to adverse reactions between ABILIFY-treated and placebo-treated pediatric patients (6 to 18 years) was 7% and 1%, respectively.

Commonly Observed Adverse Reactions

Commonly observed adverse reactions associated with the use of ABILIFY in pediatric patients with Tourette’s disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) are shown in Table 21.

Table 21:Commonly Observed Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 18 years) with Tourette’s Disorder Treated with Oral ABILIFY

Percentage of Patients Reporting Reaction

ABILIFY

Placebo

Preferred Term

(n=121)

(n=72)

Sedation

13

6

Somnolence

13

1

Nausea

11

4

Headache

10

3

Nasopharyngitis

9

0

Fatigue

8

0

Increased Appetite

7

1

Less Common Adverse Reactions in Pediatric Patients (6 to 18 years) with Schizophrenia, Bipolar Mania, Autistic Disorder, or Tourette’s Disorder

Table 22 enumerates the pooled incidence, rounded to the nearest percent, of adverse reactions that occurred during acute therapy (up to 6 weeks in schizophrenia, up to 4 weeks in bipolar mania, up to 8 weeks in autistic disorder, and up to 10 weeks in Tourette’s disorder), including only those reactions that occurred in 2% or more of pediatric patients treated with ABILIFY (doses ≥2 mg/day) and for which the incidence in patients treated with ABILIFY was greater than the incidence in patients treated with placebo.

Table 22:Adverse Reactions in Short-Term, Placebo-Controlled Trials of Pediatric Patients (6 to 18 years) Treated with Oral ABILIFY

Percentage of Patients Reporting Reactiona

System Organ Class

ABILIFY

Placebo

Preferred Term

(n=732)

(n=370)

Eye Disorders

Blurred Vision

3

0

Gastrointestinal Disorders

Abdominal Discomfort

2

1

Vomiting

8

7

Nausea

8

4

Diarrhea

4

3

Salivary Hypersecretion

4

1

Abdominal Pain Upper

3

2

Constipation

2

2

General Disorders and Administration Site Conditions

Fatigue

10

2

Pyrexia

4

1

Irritability

2

1

Asthenia

2

1

Infections and Infestations

Nasopharyngitis

6

3

Investigations

Weight Increased

3

1

Metabolism and Nutrition Disorders

Increased Appetite

7

3

Decreased Appetite

5

4

Musculoskeletal and Connective Tissue Disorders

Musculoskeletal Stiffness

2

1

Muscle Rigidity

2

1

Nervous System Disorders

Somnolence

16

4

Headache

12

10

Sedation

9

2

Tremor

9

1

Extrapyramidal Disorder

6

1

Akathisia

6

4

Drooling

3

0

Lethargy

3

0

Dizziness

3

2

Dystonia

2

1

Respiratory, Thoracic, and Mediastinal Disorders

Epistaxis

2

1

Skin and Subcutaneous Tissue Disorders

Rash

2

1

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

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