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During antipsychotic treatment, improvement in the patient's clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period.
Suicidality: The occurrence of suicidal behaviour is inherent in psychotic illnesses, and in some cases, has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see Adverse Reactions). Close supervision of high risk patients should accompany antipsychotic treatment.
Cardiovascular disorders: Abilify Maintena should be used with caution in patients with known cardiovascular disease (history of myocardial infarction or ischaemic heart disease, heart failure, or conduction abnormalities), cerebrovascular disease, conditions which would predispose patients to hypotension (dehydration, hypovolemia, and treatment with antihypertensive medicinal products) or hypertension, including accelerated or malignant.
Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Abilify Maintena and preventive measures undertaken (see Adverse Reactions).
QT prolongation: In clinical trials of treatment with oral aripiprazole, the incidence of QT prolongation was comparable to placebo. Aripiprazole should be used with caution in patients with a family history of QT prolongation (see Adverse Reactions).
Tardive dyskinesia: In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole. If signs and symptoms of tardive dyskinesia appear in a patient on Abilify Maintena, dose reduction or discontinuation of should be considered (see Adverse Reactions). These symptoms can temporally deteriorate or can even arise after discontinuation of treatment.
Neuroleptic Malignant Syndrome (NMS): NMS is a potentially fatal symptom complex associated with antipsychotic medicinal products. In clinical trials, rare cases of NMS were reported during treatment with aripiprazole. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
However, elevated creatine phosphokinase and rhabdomyolysis, not necessarily in association with NMS, have also been reported. If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, all antipsychotic medicinal products, including aripiprazole, must be discontinued (see Adverse Reactions).
Seizure: In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole. Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures (see Adverse Reactions).
Hyperglycemia and diabetes mellitus: Hyperglycemia in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics. Assessment of the relationship between atypical antipsychotics use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia and the increasing incidence of diabetes mellitus in the general population. Given this confounder, the relationship between atypical antipsychotic use and hyperglycemia-related adverse events is not completely understood. However, epidemiological studies suggest an increased risk of treatment-emergent hyperglycemia-related adverse events in patients treated with the atypical antipsychotics. Precise risk estimates for hyperglycemia-related adverse events in patients treated with atypical antipsychotics are not available.
Patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics should be monitored regularly for worsening of glucose control. Patients with risk factors for diabetes mellitus (e.g. obesity, family history of diabetes) who are starting treatment with atypical antipsychotics should undergo fasting blood glucose testing at the beginning of treatment and periodically during treatment. 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 during treatment with atypical antipsychotics should 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.
In schizophrenia clinical trials with Abilify Maintena there have been few reports of hyperglycemia and diabetes, the incidence was 0.6% and 1.1% respectively in the maintenance trials and 0% and 0.6% in the acute trial.
In the bipolar I disorder clinical trial, the incidence of hyperglycemia and diabetes were 0.8% and 0% respectively.
Hypersensitivity: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole.
Weight gain: Weight gain is commonly seen in schizophrenic patients due to use of antipsychotics known to cause weight gain, co-morbidities, poorly managed life-style and might lead to severe complications. Weight gain has been reported post-marketing among patients prescribed oral aripiprazole. When seen, it is usually in those with significant risk factors such as history of diabetes, thyroid disorder or pituitary adenoma. In clinical trials aripiprazole has not been shown to induce clinically relevant weight gain (see Adverse Reactions).
Dysphagia: Oesophageal dysmotility and aspiration have been associated with antipsychotic medicinal product use, including aripiprazole. Aripiprazole should be used cautiously in patients at risk for aspiration pneumonia.
Pathological gambling and impulse-control disorders: Patients can experience increased urges, particularly for gambling, and the inability to control these urges while taking aripiprazole. Other urges, reported include: increased sexual urges, compulsive shopping, binge or compulsive eating, and other impulsive and compulsive behaviors. It is important for prescribers to ask patients or their caregivers specifically about the development of new or increased gambling urges, or other urges while being treated with aripiprazole. It should be noted that impulse control symptoms can be associated with the underlying disorder; however, in some cases, urges were reported to have stopped when the dose was reduced or the medication was discontinued. Patients who are at higher risk for impulse-control problems (e.g. personal or family history of obsessive-compulsive disorder, impulse-control disorders, bipolar disorder, impulsive personality, alcoholism, drug abuse or other addictive behaviours) would require closer monitoring for new or worsening of uncontrollable urges. Impulse control problems may result in harm to the patient and others if not recognized.
Consider dose reduction or stopping the medication if a patient develops such urges while taking aripiprazole (see Adverse Reactions).
Falls: Antipsychotics, including aripiprazole, may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.
Orthostatic Hypotension: Aripiprazole may be associated with orthostatic hypotension, perhaps due to its α1-adrenergic receptor antagonism. Aripiprazole may induce orthostatic hypotension, tachycardia, dizziness, and sometimes syncope, especially at the initiation of treatment.
In the placebo-controlled trial in acute schizophrenia, presyncope occurred in 1/167 (0.6%) of patients treated with Abilify Maintena, while syncope and orthostatic hypotension each occurred in 1/172, (0.6%) of patients treated with placebo. There were no significant orthostatic changes in blood pressure for the Abilify Maintena treated patients or placebo-treated patients (defined as a decrease in systolic blood pressure ≥20 mmHg accompanied by an increase in heart rate ≥25 when comparing standing to supine values).
In the double-blind controlled phase of the schizophrenia maintenance clinical trials using Abilify Maintena orthostatic related events were reported in 2/534 (0.4%) patients. Orthostasis occurred in 4/576 (0.7%) patients treated with Abilify Maintena during the stabilization phase, including abnormal orthostatic blood pressure (1/576, 0.2%), postural dizziness (1/576, 0.2%), presyncope (1/576, 0.2%) and orthostatic hypotension (1/576, 0.2%). In the stabilization phase, the incidence of significant orthostatic change in blood pressure was 0.2% (1/575).
During the stabilization phase of the maintenance trial in adult patients with bipolar I disorder, syncope was the only orthostatic related adverse event reported in 0.2% of patients treated with Abilify Maintena. Incidence of potential clinically relevant orthostatic hypotension reported during the Abilify Maintena stabilization phase in bipolar I disorder was 0.2% (1/421) and during the double-blind, placebo-controlled phase, there were no differences reported in either treatment group.
Aripiprazole should be used with caution in patients with known cardiovascular disease (e.g. history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (e.g., dehydration, hypovolemia, and treatment with antihypertensive medications). Patients with a history of clinically significant cardio vascular disorders were excluded from clinical trials.
Effects on ability to drive and use machines: Abilify Maintena can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see Adverse Reactions). Therefore, patients should be advised not to drive or operate machines until their individual susceptibility to this medicinal product is known.
Elderly patients with dementia-related psychosis: Increased mortality: In three placebo-controlled trials of oral aripiprazole in elderly patients with psychosis associated with Alzheimer's disease (n = 938; mean age: 82.4 years; range: 56-99 years), patients treated with aripiprazole are at an increased risk of death compared to placebo. The rate of death in oral aripiprazole-treated patients was 3.5 % compared to 1.7 % in the placebo group. Although the causes of deaths were varied, most of the deaths appeared to be either cardiovascular (e.g. heart failure, sudden death) or infectious (e.g. pneumonia) in nature (see Adverse Reactions).
Cerebrovascular adverse reactions: In the same trials with oral aripiprazole, cerebrovascular adverse reactions (e.g. stroke, transient ischaemic attack), including fatalities, were reported in patients (mean age: 84 years; range: 78-88 years). Overall, 1.3 % of oral aripiprazole-treated patients reported cerebrovascular adverse reactions compared with 0.6 % of placebo-treated patients in these trials. This difference was not statistically significant. However, in one of these trials, a fixed-dose trial, there was a significant dose response relationship for cerebrovascular adverse reactions in patients treated with aripiprazole (see Adverse Reactions).
Abilify Maintena is not indicated for the treatment of patients with dementia-related psychosis.
