Safety Data

ABILIFY MAINTENA® (aripiprazole) safety

Clinical safety profile

The safety profile of ABILIFY ASIMTUFII® (aripiprazole) 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 schizophrenia

Adverse reactions*
in ≥2% of patients
SYSTEM ORGAN CLASS PREFERRED TERM ABILIFY MAINTENA
(%, n=167)
PLACEBO
(%, n=172)
GASTROINTESTINAL DISORDERS
GASTROINTESTINAL DISORDERS Constipation 10 7
Dry mouth 4 2
Diarrhea 3 2
Vomiting 3 1
Abdominal discomfort 2 1
GENERAL DISORDERS AND ADMINISTRATION SITE CONCERNS
GENERAL DISORDERS AND ADMINISTRATION SITE CONCERNS Injection site pain 5 1
INFECTIONS AND INFESTATIONS
INFECTIONS AND INFESTATIONS Upper respiratory tract infection 4 2
INVESTIGATIONS
INVESTIGATIONS Increased weight 17 7
Decreased weight 4 2
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS Arthralgia 4 1
Back pain 4 2
Myalgia 4 2
Musculoskel­et­al pain 3 1
NERVOUS SYSTEM DISORDERS
NERVOUS SYSTEM DISORDERS Akathisia 11 4
Sedation 5 1
Dizziness 4 2
Tremor 3 1
RESPIRATORY, THORACIC,
AND MEDIASTINAL
RESPIRATORY, THORACIC,
AND MEDIASTINAL
Nasal congestion 2 1

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

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

Adverse Reactions, ChartIncreased weight16.8%16.8%7.0%Akathisia11.4%11.4%3.5%Injection site pain5.4%5.4%0.6%Sedation5.4%5.4%1.2%ABILIFY MAINTENA (n=167)Placebo (n=172)
Adverse Reactions, ChartABILIFY MAINTENA (n=167)Placebo (n=172)Increased weight16.8%16.8%7.0%Akathisia11.4%11.4%3.5%Injection site pain5.4%5.4%0.6%Sedation5.4%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


12-week, double-blind, placebo-controlled study

Injection site reactions for ABILIFY MAINTENA

5.4% of patients treated with gluteal-administered ABILIFY MAINTENA reported injection site pain compared with 0.6% on placebo

Mean intensity of ABILIFY MAINTENA injection pain reported by patients

Injection Pain, Chart~1 hour after first injection (SD 14.5) 7.14.8At the last visit (SD 12.4)Unbearably painful100No pain0SD=standard deviation.ABILIFY MAINTENA 400 mg
Injection Pain, Chart01007.1~1 hour after first injection (SD 14.5) 4.8At the last visit (SD 12.4)No painUnbearably painfulSD=standard deviation.ABILIFY MAINTENA 400 mg

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

Prolactin and extrapyramidal symptoms (EPS) in schizophrenia

    ABILIFY MAINTENA
400 MG
PLACEBO
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 400 MG PLACEBO
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.

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

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


Metabolic safety profile in schizophrenia

METABOLIC MEASURE   ABILIFY MAINTENA
400 MG
PLACEBO
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)
METABOLIC MEASURE
ABILIFY MAINTENA 400 MG PLACEBO
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 disorder

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

Metabolic safety profile in bipolar I disorder

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
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.

  • In those patients who initiated ABILIFY MAINTENA, 1.8% discontinued ABILIFY MAINTENA treatment due to weight increase
  • ABILIFY MAINTENA was associated with mean increase in weight from baseline of 1.0 kg at Week 52
  • 21.4% of these patients demonstrated a ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight

See dosing and administration information for ABILIFY MAINTENA.