Safety Data
ABILIFY MAINTENA® (aripiprazole) safety data
Clinical safety profile
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 | Constipatifon | 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
0 patients on ABILIFY MAINTENA or placebo discontinued due to these four adverse reactions1
In a 12-week study, 4.2% of patients on ABILIFY MAINTENA discontinued
due to all adverse reactions vs 7.6% with placebo.2
12-week, double-blind,
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
The following safety information is derived from a 12-week, double-blind study in patients with schizophrenia
Prolactin and extrapyramidal symptoms (EPS) in schizophrenia1
| ABILIFY MAINTENA 400 MG |
PLACEBO | ||
|---|---|---|---|
| PROLACTIN1,2 | 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 REACTIONS1,2 | Incidence of EPS-related events, excluding akathisia, % (n/N) | 9.6% (16/167) | 5.2% (9/172) |
| ABILIFY MAINTENA 400 MG | PLACEBO |
|---|---|
| PROLACTIN1,2 | |
| 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 REACTIONS1,2 | |
| 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%).1
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, but did not participate in the 52-week, double-blind 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.