Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia, including polydipsia, polyuria, polyphagia, and weakness. Patients with diabetes should be regularly monitored for worsening of glucose control those with risk factors for diabetes should undergo baseline and periodic fasting blood glucose testing. There have been reports of hyperglycemia in patients treated with oral aripiprazole. Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics.Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include: TD may remit, partially or completely, if antipsychotic treatment is withdrawn. Discontinue ARISTADA if clinically appropriate. Prescribing antipsychotics should be consistent with the need to minimize TD. The syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Tardive Dyskinesia (TD): The risk of developing TD (a syndrome of abnormal, involuntary movements) and the potential for it to become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic increase. The management of NMS should include: 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy 2) intensive symptomatic treatment and medical monitoring and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. Clinical manifestations of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles. ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis. Reactions have ranged from pruritus/urticaria to anaphylaxis.Ĭerebrovascular Adverse Reactions, Including Stroke: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack), including fatalities, have been reported in placebo-controlled trials of elderly patients with dementia-related psychosis treated with risperidone, aripiprazole, and olanzapine. Under no circumstances will Alkermes, Inc., or its affiliates, employees, consultants, agents or representatives be liable for costs, expenses, losses, claims, liabilities or other damages that may arise from, or be incurred in connection with, the information provided here or any use thereof.Ĭontraindication: Known hypersensitivity reaction to aripiprazole. Alkermes does not guarantee coverage or reimbursement. Additional insurance requirements may apply and healthcare providers should always contact the insurer directly to obtain complete and current information regarding coverage of ARISTADA and/or ARISTADA INITIO. Healthcare providers also are responsible for the accuracy of all claims and related documentation submitted for reimbursement. †IMPORTANT: Healthcare providers are responsible for keeping current and complying with all applicable coverage requirements and for the selection of diagnosis and procedure codes that accurately reflect their patient’s condition and the services rendered. If not starting with ARISTADA INITIO, administer oral aripiprazole for 21 consecutive days with the first ARISTADA injection 5.*Administer 1 injection of ARISTADA INITIO and a single 30 mg dose of oral aripiprazole with the first ARISTADA injection 5.Injection, aripiprazole lauroxil, (ARISTADA), 1 mg Injection, aripiprazole lauroxil, (ARISTADA INITIO), 1 mg
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