The clinical safety profile of
ABILIFY MAINTENA® (aripiprazole)
ABILIFY MAINTENA has been evaluated for safety in more than 2,000 adult patients with schizophrenia
The following safety information is derived from a 12-week, double-blind study or an open-label study.
Adverse reactions in ≥2% of
ABILIFY MAINTENA–treated adult patients with schizophrenia in a 12-week, double-blind, placebo-controlled study
*Table excludes adverse reactions that had an incidence equal to or less than placebo.
- Most commonly observed adverse reactions (incidence ≥5% for
ABILIFY MAINTENAand at least twice that for placebo) were increased weight (16.8% vs 7.0%), akathisia (11.4% vs 3.5%), injection site pain (5.4% vs 0.6%), and sedation (5.4% vs 1.2%)
- The mean intensity of injection pain reported by patients using a visual analog scale (0=no pain to 100=unbearably painful) approximately 1 hour after injection was 7.1
(SD 14.5)for the first injection and 4.8 (SD 12.4)at the last visit
- The incidence of discontinuation before Week 10 due to adverse reactions was 4.2% for patients on
ABILIFY MAINTENAand 7.6% for placebo1
- In an open-label study comparing bioavailability of
ABILIFY MAINTENA® (aripiprazole)administered in the deltoid or gluteal muscle, injection site pain was observed in both groups at approximately equal rates
The following safety information is derived from a 12-week, double-blind study in patients with schizophrenia.
Prolactin and extrapyramidal symptoms (EPS)
n=number of patients with event; N=number of patients treated; SD=standard deviation.
†AM N=99, placebo N=66.
‡Incidence for AM vs placebo in female subjects
Metabolic safety profile
HDL=high-density lipoprotein; LDL=low-density lipoprotein.
ABILIFY MAINTENA has been evaluated for safety in multiple studies in more than 800 adult patients 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
Metabolic safety profile in
bipolar I disorder
This safety data is from those patients who were initiated on
- During the 52-week, open-label bipolar I disorder study in those patients who initiated
ABILIFY MAINTENA,1.8% discontinued ABILIFY MAINTENAtreatment due to weight increase ABILIFY MAINTENAwas associated with mean increase from baseline in weight of 1.0 kg at week 52
- In this trial, 21.4% of these patients demonstrated a ≥7% increase in body weight and 15.4% demonstrated a ≥7% decrease in body weight
Important Warning and Precaution Regarding Metabolic Changes:
Atypical antipsychotic drugs have caused metabolic changes including:
- Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics including aripiprazole. Patients with diabetes mellitus should be regularly monitored for worsening of glucose control; those with risk factors for diabetes (e.g., obesity, family history of diabetes), should undergo baseline and periodic fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of anti-diabetic treatment despite discontinuation of the suspect drug.
- Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
- Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.