Safety Data

The safety of ABILIFY MAINTENA® (aripiprazole) is based on an adequate and well-controlled study of ABILIFY MAINTENA® (aripiprazole) in patients living with schizophrenia.

Clinical safety profile

The safety profile of ABILIFY ASIMTUFII was comparable to that seen with ABILIFY MAINTENA1

Adverse reactions in ≥2% of patients in a 12-week, double-blind, placebo-controlled study of adult patients living with schizophrenia1

Adverse reactions* in ≥2% of patients
SYSTEM ORGAN CLASSPREFERRED TERMABILIFY MAINTENA (%, n=167)PLACEBO (%, n=172)
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL DISORDERSConstipation107
Dry mouth42
Diarrhea32
Vomiting31
Abdominal discomfort21
GENERAL DISORDERS AND ADMINISTRATION SITE CONCERNS
GENERAL DISORDERS AND ADMINISTRATION SITE CONCERNSInjection site pain51
INFECTIONS AND INFESTATIONS
INFECTIONS AND INFESTATIONSUpper respiratory tract infection42
INVESTIGATIONS
INVESTIGATIONSIncreased weight177
Decreased weight42
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERSArthralgia41
Back pain42
Myalgia42
Musculoskel­et­al pain31
NERVOUS SYSTEM DISORDERS
NERVOUS SYSTEM DISORDERSAkathisia114
Sedation51
Dizziness42
Tremor31
RESPIRATORY, THORACIC,                            
AND MEDIASTINAL
RESPIRATORY, THORACIC,                            
AND MEDIASTINAL		Nasal congestion21

*Table excludes adverse reactions that had an incidence of ≤ placebo.1

Adverse reactions with an incidence ≥5% of patients and at least twice that for placebo1

Adverse Reactions, Chart Increased weight 16.8% 16.8% 7.0% Akathisia 11.4% 11.4% 3.5% Injection site pain 5.4% 5.4% 0.6% Sedation 5.4% 5.4% 1.2% ABILIFY MAINTENA (n=167) Placebo (n=172)
Adverse Reactions, Chart ABILIFY MAINTENA (n=167) Placebo (n=172) Increased weight 16.8% 16.8% 7.0% Akathisia 11.4% 11.4% 3.5% Injection site pain 5.4% 5.4% 0.6% Sedation 5.4% 5.4% 1.2%

0 patients on ABILIFY MAINTENA or placebo discontinued due to these four adverse reactions2

In a 12-week study, 4.2% of patients on ABILIFY MAINTENA discontinued
due to all adverse reactions vs 7.6% with placebo.3

32-week, open-label, multiple-dose, randomized, parallel arm-study:

Injection site reactions for ABILIFY ASIMTUFII or ABILIFY MAINTENA

The percentage of patients in the open-label study reporting any injection-site-related adverse reactions (all reported as injection site pain) was 19% for patients treated with ABILIFY ASIMTUFII 960 mg and 9% for patients treated with ABILIFY MAINTENA 400 mg4

0 100 Unbearably
 painful No pain 3.0 3.7 1.3 1.4 ABILIFY ASIMTUFII 960 mg ABILIFY MAINTENA 400 mg
0 100 ABILIFY ASIMTUFII 960 mg ABILIFY MAINTENA 400 mg 3.0 3.7 First injection postdose First injection postdose Last injection postdose Last injection postdose 1.3 1.4 No pain No pain Unbearably painful Unbearably painful

The following safety information is derived from 12-week, double-blind study in patients with schizophrenia

Prolactin and extrapyramidal symptoms (EPS) in schizophrenia2

  ABILIFY MAINTENA 400 MGPLACEBO
PROLACTIN2Mean change from baseline to Week 12; ng/mL (SD) (P=0.0176)†-6.4 (13.5)-1.1 (14.5)
Potentially clinically relevant prolactin levels (>1x upper limit of normal)–any post-baseline visit, (n/N)‡2.8% (4/142)11.4% (16/140)
ADVERSE REACTIONS2Incidence of EPS-related events, excluding akathisia, % (n/N)9.6% (16/167)5.2% (9/172)
ABILIFY MAINTENA 400 MGPLACEBO
PROLACTIN2
Mean change from baseline to Week 12;                            
ng/mL (SD) (P=0.0176)†
-6.4 (13.5)-1.1 (14.5)
Potentially clinically relevant prolactin levels (>1x upper limit of normal)–any post-baseline visit, (n/N)‡
2.8% (4/142)11.4% (16/140)
ADVERSE REACTIONS2
Incidence of EPS-related events, excluding akathisia, % (n/N)
9.6% (16/167)5.2% (9/172)

†ABILIFY MAINTENA, n=99; placebo, n=66.2

‡Incidence for ABILIFY MAINTENA vs placebo in female subjects (6.3% vs 13.8%) and male subjects (1.8% vs 10.8%).2

n=number of patients with event; N=number of patients treated; SD=standard deviation.

Metabolic safety profile in schizophrenia4

METABOLIC MEASURE ABILIFY MAINTENA 400 MGPLACEBO
FASTING GLUCOSE% (n/N) of patients who shifted from normal to high (<100 mg/dL to ≥126 mg/dL)8.0% (7/88)0.0% (0/75)
TOTAL CHOLESTEROL% (n/N) of patients who shifted from normal to high (<200 mg/dL to ≥240 mg/dL)3.6% (3/83)2.7% (2/73)
FASTING LDL CHOLESTEROL% (n/N) of patients who shifted from normal to high (<100 mg/dL to ≥160 mg/dL)1.7% (1/59)2.0% (1/51)
HDL CHOLESTEROL% (n/N) of patients who shifted from normal to low (≥40 mg/dL to <40 mg/dL)13.5% (14/104)12.6% (11/87)
FASTING TRIGLYCERIDES% (n/N) of patients who shifted from normal to high (<150 mg/dL to ≥200 mg/dL)7.1% (7/98)5.1% (4/78)
WEIGHT GAINMean change from baseline to Week 12, kg+3.5+0.8
Weight gain ≥7% of body weight, % (n/N)21.5% (31/144)8.5 (12/141)
METABOLIC MEASURE
ABILIFY MAINTENA 400 MGPLACEBO
FASTING GLUCOSE
% (n/N) of patients who shifted from normal to high (<100 mg/dL to ≥126 mg/dL)
8.0% (7/88)0.0% (0/75)
TOTAL CHOLESTEROL
% (n/N) of patients who shifted from normal to high (<200 mg/dL to ≥240 mg/dL)
3.6% (3/83)2.7% (2/73)
FASTING LDL CHOLESTEROL
% (n/N) of patients who shifted from normal to high (<100 mg/dL to ≥160 mg/dL)
1.7% (1/59)2.0% (1/51)
HDL CHOLESTEROL
% (n/N) of patients who shifted from normal to low (≥40 mg/dL to <40 mg/dL)
13.5% (14/104)12.6% (11/87)
FASTING TRIGLYCERIDES
% (n/N) of patients who shifted from normal to high (<150 mg/dL to ≥200 mg/dL)
7.1% (7/98)5.1% (4/78)
WEIGHT GAIN
Mean change from baseline to Week 12, kg
+3.5+0.8
Weight gain ≥7% of body weight, % (n/N)
21.5% (31/144)8.5 (12/141)

HDL=high-density lipoprotein; LDL=low-density lipoprotein.

ABILIFY MAINTENA has been evaluated for safety in multiple studies in more than 800 adult patients living with bipolar I disorder4

The following safety information was derived from a 52-week, open-label study in patients with bipolar I disorder initiated on ABILIFY MAINTENA.4

Metabolic safety profile in bipolar I disorder4

METABOLIC MEASURE 
GLUCOSE1.1% of patients experienced a shift from normal to high fasting glucose
9.8% of patients experienced a shift from borderline to high fasting glucose
2.9% of patients experienced shifts from normal to borderline to high fasting glucose
TOTAL CHOLESTEROL2.1% of patients experienced a shift from normal to high fasting cholesterol
LDL CHOLESTEROL2.2% of patients experienced a shift from normal to high fasting cholesterol
HDL CHOLESTEROL8.5% of patients experienced a shift from normal to low fasting cholesterol
TRIGLYCERIDES3.6% of patients experienced a shift from normal to high fasting triglycerides
0.0% of patients experienced a shift from normal to very high fasting triglycerides
1.0% of patients experienced a shift from normal or borderline to very high fasting triglycerides
METABOLIC MEASURE
GLUCOSE
1.1% of patients experienced a shift from normal to high fasting glucose
9.8% of patients experienced a shift from borderline to high fasting glucose
2.9% of patients experienced shifts from normal to borderline to high fasting glucose
TOTAL CHOLESTEROL
2.1% of patients experienced a shift from normal to high fasting cholesterol
LDL CHOLESTEROL
2.2% of patients experienced a shift from normal to high fasting cholesterol
HDL CHOLESTEROL
8.5% of patients experienced a shift from normal to low fasting cholesterol
TRIGLYCERIDES
3.6% of patients experienced a shift from normal to high fasting triglycerides
0.0% of patients experienced a shift from normal to very high fasting triglycerides
1.0% of patients experienced a shift from normal or borderline to very high fasting triglycerides

These safety data are from those patients who were initiated on ABILIFY MAINTENA during a 52-week, open-label study.4

  • In those patients who initiated ABILIFY MAINTENA, 1.8% discontinued ABILIFY MAINTENA treatment due to weight increase4
  • ABILIFY MAINTENA was associated with mean increase in weight from baseline of 1.0 kg at Week 524
  • 21.4% of these patients demonstrated a ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight4

See dosing and administration information for ABILIFY ASIMTUFII

ABILIFY ASIMTUFII Dosing and Administration