CLINICAL SAFETY PROFILE OF
ABILIFY MAINTENA® (aripiprazole)
ABILIFY MAINTENA has been evaluated for safety in more than 2,000 adult patients with schizophrenia
Adverse reactions in ≥2% of patients in a 12‑week, double‑blind, placebo‑controlled study
Adverse reactions with an incidence ≥5% of patients and at least twice that for placebo
In a 12-week study, 4.2% of patients on
ABILIFY MAINTENA discontinued due to all adverse reactions vs 7.6% with placebo1
Prolactin and extrapyramidal symptoms (EPS) in schizophrenia
n=number of patients with event; N=number of patients treated; SD=standard deviation.
Metabolic safety profile in schizophrenia
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
Metabolic safety profile in
bipolar I disorder
This safety data is from those patients who were initiated on
- In those patients who were initiated
ABILIFY MAINTENA, 1.8% discontinued ABILIFY MAINTENAtreatment due to weight increase ABILIFY MAINTENAwas 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
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
- 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.