Abilify Oral Tablets, Orally-Disintegrating Tablets, and Oral Solution are indicated for:

Schizophrenia:

• Treatment of schizophrenia in adult and adolescent patients (13 to 17 years of age).

Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder:

• Acute treatment of manic and mixed episodes associated with bipolar I disorder as monotherapy and adjunctive therapy with lithium or valproate in adult and pediatric patients (10 to 17 years of age).

Adjunctive Treatment of Major Depressive Disorder:

• Adjunctive treatment of major depressive disorder in adult patients.

Irritability Associated with Autistic Disorder:

• Treatment of irritability associated with autistic disorder in pediatric patients (6 to 17 years of age).

Tourette’s Disorder:

• Treatment of Tourette’s disorder in pediatric patients (6 to 18 years of age).

Abilify Injection is indicated for:

• Treatment of agitation associated with schizophrenia or bipolar mania in adult patients.

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ABILIFY is not approved for the treatment of patients with dementia-related psychosis.

ABILIFY is not approved for use in treating depression in the pediatric population.

Children, adolescents, and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders are at increased risk of suicidal thinking and behavior. All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.

Dosage adjustment is recommended in known CYP2D6 poor metabolizers due to high aripiprazole concentrations. Approximately 8% of Caucasians and 3–8% of Black/African Americans cannot metabolize CYP2D6 substrates and are classified as poor metabolizers (PM).

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) may occur with administration of antipsychotic drugs, including ABILIFY.

In clinical trials and/or postmarketing experience, events of leukopenia and neutropenia have been reported temporally related to antipsychotic agents, including ABILIFY. Agranulocytosis has also been reported.

Post-marketing case reports suggest that patients can experience intense urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other compulsive urges, reported less frequently include: sexual urges, shopping, eating or binge eating, and other impulsive or compulsive behaviors.

Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Esophageal dysmotility and aspiration have been associated with antipsychotic drug use, including ABILIFY. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer’s dementia.

Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia, diabetes mellitus, and dyslipidemia.

Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics.

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents.

ABILIFY may cause orthostatic hypotension, perhaps due to its a1-adrenergic receptor antagonism.

Antipsychotics, including ABILIFY, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries.

ABILIFY should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medications).

In placebo-controlled clinical studies (two flexible dose and one fixed dose study) of dementia-related psychosis, there was an increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, in ABILIFY-treated patients (mean age: 84 years; range: 78 to 88 years).

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. The risk of developing tardive dyskinesia and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.

As with other antipsychotic drugs, ABILIFY should be used cautiously in patients with a history of seizures or with conditions that lower the seizure threshold.

The concomitant use of ABILIFY with strong CYP3A4 Inhibitors (e.g., itraconazole, clarithromycin) or strong CYP2D6 inhibitors (e.g., quinidine, fluoxetine, paroxetine) increased the exposure of aripiprazole compared to the use of ABILIFY alone.

The concomitant use of ABILIFY and carbamazepine decreased the exposure of aripiprazole compared to the use of ABILIFY alone.

Due to its alpha adrenergic antagonism, aripiprazole has the potential to enhance the effect of certain antihypertensive agents.

The intensity of sedation was greater with the combination of oral aripiprazole and lorazepam as compared to that observed with aripiprazole alone. The orthostatic hypotension observed was greater with the combination as compared to that observed with lorazepam alone.

Neonates exposed to antipsychotic drugs (including ABILIFY) during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms. Animal studies: fetal death, decreased fetal weight, undescended testicles, delayed skeletal ossification, skeletal abnormalities, and diaphragmatic hernia.

ABILIFY is present in human breast milk. Because of the potential for serious adverse reactions in nursing infants from ABILIFY, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

GoToSource

• Dementia. GoToSource

• Stimulant dependence. GoToSource

• Alcohol dependence. GoToSource

• Generalized anxiety disorder, social anxiety and post-traumatic stress disorder. GoToSource

• Oppositional defiant disorder. GoToSource

• Autism. GoToSource

• Attention deficit hyperactivity disorder. GoToSource

• Use in patients under 6 years of age. GoToSource

• Monotherapy for major depressive disorder. GoToSource

• Psychosis, agitation, insomnia and eating disorders. GoToSource

• Developmental disability. GoToSource

• Restless legs syndrome and trichotillomania. GoToSource

• Obsessive-compulsive disorder. GoToSource

• Drug-induced psychosis in parkinson disease. GoToSource

• Borderline personality disorder. GoToSource

• Primary delusional parasitosis. GoToSource

• Migraines. GoToSource

• Psychosis associated with alzheimer’s disease. GoToSource

• Treatment for aggression. GoToSource

Elderly patients with dementia-related psychosis are at increased risk of death and strokes. GoToSource

Patients with CYP2D6 gene results in higher systemic concentrations and higher adverse reaction risk. GoToSource

Tardive dyskinesia (involuntary movements). GoToSource

Psychosis. GoToSource

Increased risk of suicidal thinking and behavior. GoToSource

Neuroleptic malignant syndrome (life-threatening reaction to neuroleptic medications). GoToSource

Weight gain, hyperglycemia (high blood sugar) and diabetes. GoToSource

Orthostatic hypotension (fall in blood pressure when upright position is assumed) and cardiac arrhythmia. GoToSource

Constipation, sedation, tremor, restlessness and seizures. GoToSource

Insomnia and anxiety. GoToSource

Impulse-control problems including compulsive or uncontrollable urges to gamble, binge eat, shop and have sex. GoToSource

Dysphagia (difficulty swallowing). GoToSource

Leukopenia (decrease in white blood cells), neutropenia (low level of neutrophils a type of white blood cell) and agranulocytosis (bone marrow does not produce enough white blood cells). GoToSource

Cerebrovascular events including strokes, increased cognitive decline and increased risk of death due to pneumonia. GoToSource

Lawsuits filed for diabetes, hyperglycemia, neuroleptic malignant syndrome, tardive dyskinesia and strokes.