Adverse reactions in ≥2% of patients in a 12-week, double-blind, placebo-controlled study
|Percentage of patients reporting reaction*|
|System Organ Class||Preferred Term||Abilify Maintena (n=167)||Placebo (n=172)|
|General disorders and administration site conditions||Injection site pain||5||1|
|Infections and infestations||Upper respiratory tract infection||4||2|
|Musculoskeletal and connective tissue disorders||Arthralgia||4||1|
|Nervous system disorders||Akathisia||11||4|
|Respiratory, thoracic, and mediastinal||Nasal congestion||2||1|
*Table excludes adverse reactions that had an incidence ≤ placebo.
Adverse reactions with an incidence ≥5% of patients and at least twice that for placebo
on ABILIFY MAINTENA or placebo discontinued due to these 4 adverse reactions1
In a 12-week study, 4.2% of patients on ABILIFY MAINTENA discontinued due to all adverse reactions vs 7.6% with placebo2
The following safety information is derived from a 12-week, double-blind study in patients with schizophrenia.1
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 revelant prolactin levels (>1x upper limit of normal)—any post-baseline visit, % (n/N)‡||2.8% (4/142)||11.4% (16/140)|
|ADVERSE REACTION1,2||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 MEASURE1||ABILIFY MAINTENA 400 mg||Placebo|
|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)|
|LDL CHOLESTEROL||% (n/N) of patients who shifted from normal to high (<200 mg/dL to ≥240 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)|
|TRIGLYCERIDES||% (n/N) of patients who shifted from normal to low (≥40 mg/dL to <40 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 I disorder initiated on ABILIFY MAINTENA.
Metabolic safety profile in bipolar I disorder
|GLUCOSE||% of patients who experienced a shift from normal to high fasting glucose||1.1%|
|% of patients who experienced a shift from borderline to high fasting glucose||9.8%|
|% of patients who experienced shifts from normal to borderline to high fasting glucose||2.9%|
|TOTAL CHOLESTEROL||% of patients who experienced a shift from normal to high fasting cholesterol||2.1%|
|LDL CHOLESTEROL||% of patients who experienced a shift from normal to high fasting cholesterol||2.2%|
|HDL CHOLESTEROL||% of patients who experienced a shift from normal to low fasting cholesterol||8.5%|
|TRIGLYCERIDES||% of patients who experienced a shift from normal to high fasting triglycerides||3.6%|
|% of patients who experienced a shift from normal to very high fasting triglycerides||0.0%|
|% of patients who experienced a shift from normal or borderline to very high fasting triglycerides||1.0%|
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
Considering ABILIFY MAINTENA for your patients?
Ready to initiate ABILIFY MAINTENA?
See how you can get appropriate patients started on ABILIFY MAINTENA.
See the pharmacokinetic data for ABILIFY MAINTENA in adult patients with schizophrenia.
References: 1. Data on file. ABIMAI-124. 2. Kane JM, Peters-Strickland T, Baker RA, et al. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014;75(11):1254-1260.