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%).
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?
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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.