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ARISTADA INITIO and ARISTADA Patient Transition Form

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PATIENT TRANSITION FORM Discharge planner to complete information and attach to discharge plan for next place of care. Patient name Date of birth Appointment date at next place of care Hospital injection information (Name of hospital here) In-hospital treatment regimen initiated with the first ARISTADA® (aripiprazole lauroxil) injection (check one) One-time injection of ARISTADA INITIO® (aripiprazole lauroxil) + a single dose of 30 mg oral aripiprazole 21 consecutive days of oral aripiprazole Oral aripiprazole dose (check one) 10 mg 15 mg 20 mg 30 mg Start date ARISTADA dose and frequency (check one) 441 mg, 882 mg, 1064 mg, once every 4 weeks once every 4 weeks once every 2 months 662 mg, 882 mg, once every 4 weeks once every 6 weeks Date of first ARISTADA injection Date of next ARISTADA injection If the patient misses their next dose of ARISTADA, administer the next injection of ARISTADA as soon as possible. Depending on the time elapsed since the last ARISTADA injection, supplementation may be recommended. See missed dose guidance in the ARISTADA full Prescribing Information. INDICATION ARISTADA INITIO® (aripiprazole lauroxil), in combination with oral aripiprazole, is indicated for the initiation of ARISTADA® (aripiprazole lauroxil) when used for the treatment of schizophrenia in adults. ARISTADA is indicated for the treatment of schizophrenia in adults. IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO AND ARISTADA WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis. Please see additional Important Safety Information and full Prescribing Information, including Boxed Warning, for ARISTADA INITIO and ARISTADA. IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO AND ARISTADA INDICATION and IMPORTANT SAFETY TD may remit, partially or completely, if Body Temperature Regulation: Disruption of the INFORMATION for ARISTADA INITIO® antipsychotic treatment is withdrawn. body’s ability to reduce core body temperature (aripiprazole lauroxil) and ARISTADA® Metabolic Changes: Atypical antipsychotic has been attributed to antipsychotic agents. (aripiprazole lauroxil) extended-release drugs have been associated with metabolic Advise patients regarding appropriate care in changes that include: avoiding overheating and dehydration. injectable suspension, for intramuscular use Appropriate care is advised for patients who • Hy perglycemia/Diabetes Mellitus: may exercise strenuously, may be exposed to INDICATION Hyperglycemia, in some cases extreme and extreme heat, receive concomitant medication ARISTADA INITIO, in combination with oral associated with ketoacidosis, coma, or death, with anticholinergic activity, or are subject to aripiprazole, is indicated for the initiation of has been reported in patients treated with dehydration. ARISTADA when used for the treatment of atypical antipsychotics. There have been schizophrenia in adults. reports of hyperglycemia in patients treated Dysphagia: Esophageal dysmotility and aspiration have been associated with ARISTADA is indicated for the treatment of with oral aripiprazole. Patients with diabetes antipsychotic drug use; use caution in patients at schizophrenia in adults. should be regularly monitored for worsening of glucose control; those with risk factors for risk for aspiration pneumonia. IMPORTANT SAFETY INFORMATION diabetes should undergo baseline and Concomitant Medication: ARISTADA INITIO is periodic fasting blood glucose testing. Any only available at a single strength as a single- WARNING: INCREASED MORTALITY IN patient treated with atypical antipsychotics dose pre-filled syringe, so dosage adjustments ELDERLY PATIENTS WITH DEMENTIA- should be monitored for symptoms of are not possible. Avoid use in patients who are RELATED PSYCHOSIS hyperglycemia, including polydipsia, polyuria, known CYP2D6 poor metabolizers or taking polyphagia, and weakness. Patients who strong CYP3A4 inhibitors, strong CYP2D6 Elderly patients with dementia-related develop symptoms of hyperglycemia should inhibitors, or strong CYP3A4 inducers, psychosis treated with antipsychotic drugs are also undergo fasting blood glucose testing. In antihypertensive drugs or benzodiazepines. at an increased risk of death. ARISTADA some cases, hyperglycemia has resolved INITIO and ARISTADA are not approved for Depending on the ARISTADA dose, adjustments the treatment of patients with dementia- when the atypical antipsychotic was may be recommended if patients are 1) known as related psychosis. discontinued; however, some patients require CYP2D6 poor metabolizers and/or 2) taking continuation of antidiabetic treatment despite strong CYP3A4 inhibitors, strong CYP2D6 discontinuation of the suspect drug. Contraindication: Known hypersensitivity inhibitors, or strong CYP3A4 inducers for greater reaction to aripiprazole. Reactions have ranged • D yslipidemia: Undesirable alterations in lipids than 2 weeks. Avoid use of ARISTADA 662 mg, from pruritus/urticaria to anaphylaxis. have been observed in patients treated with 882 mg, or 1064 mg for patients taking both atypical antipsychotics. strong CYP3A4 inhibitors and strong CYP2D6 Cerebrovascular Adverse Reactions, Including inhibitors. (See Table 4 in the ARISTADA full Stroke: Increased incidence of cerebrovascular • W eight Gain: Weight gain has been observed Prescribing Information.) adverse reactions (e.g., stroke, transient ischemic with atypical antipsychotic use. Clinical attack), including fatalities, have been reported monitoring of weight is recommended. Commonly Observed Adverse Reactions: In in placebo-controlled trials of elderly patients Pathological Gambling and Other Compulsive pharmacokinetic studies the safety profile of with dementia-related psychosis treated with Behaviors: Compulsive or uncontrollable urges ARISTADA INITIO was generally consistent with risperidone, aripiprazole, and olanzapine. to gamble have been reported with use of that observed for ARISTADA. The most common ARISTADA INITIO and ARISTADA are not aripiprazole. Other compulsive urges less adverse reaction (≥5% incidence and at least approved for the treatment of patients with frequently reported include sexual urges, twice the rate of placebo reported by patients dementia-related psychosis. shopping, binge eating and other impulsive or treated with ARISTADA 441 mg and 882 mg monthly) was akathisia. Potential for Dosing and Medication Errors: compulsive behaviors which may result in harm Medication errors, including substitution and for the patient and others if not recognized. Injection-Site Reactions: In pharmacokinetic dispensing errors, between ARISTADA INITIO Closely monitor patients and consider dose studies evaluating ARISTADA INITIO, the and ARISTADA could occur. ARISTADA INITIO is reduction or stopping aripiprazole if a patient incidences of injection-site reactions with intended for single administration in contrast to develops such urges. ARISTADA INITIO were similar to the incidence ARISTADA which is administered monthly, every Orthostatic Hypotension: Aripiprazole may observed with ARISTADA. Injection-site 6 weeks, or every 8 weeks. Do not substitute cause orthostatic hypotension which can be reactions were reported by 4%, 5%, and 2% of ARISTADA INITIO for ARISTADA because of associated with dizziness, lightheadedness, and patients treated with 441 mg ARISTADA differing pharmacokinetic profiles. tachycardia. Monitor heart rate and blood (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were Neuroleptic Malignant Syndrome (NMS): A pressure, and warn patients with known injection-site pain and associated with the first potentially fatal symptom complex may occur cardiovascular or cerebrovascular disease and injection and decreased with each subsequent with administration of antipsychotic drugs, risk of dehydration and syncope. injection. Other injection-site reactions including ARISTADA INITIO and ARISTADA. Falls: Antipsychotics including ARISTADA INITIO (induration, swelling, and redness) occurred at Clinical manifestations of NMS include and ARISTADA may cause somnolence, postural less than 1%. hyperpyrexia, muscle rigidity, altered mental hypotension or motor and sensory instability status, and evidence of autonomic instability which may lead to falls and subsequent injury. Dystonia: Symptoms of dystonia, prolonged (irregular pulse or blood pressure, tachycardia, Upon initiating treatment and recurrently, abnormal contractions of muscle groups, may diaphoresis, and cardiac dysrhythmia). complete fall risk assessments as appropriate. occur in susceptible individuals during the first days of treatment and at low doses. Additional signs may include elevated creatine Leukopenia, Neutropenia, and Agranulocytosis: phosphokinase, myoglobinuria (rhabdomyolysis), Leukopenia, neutropenia and agranulocytosis Pregnancy/Nursing: May cause extrapyramidal and acute renal failure. The management of NMS have been reported with antipsychotics. and/or withdrawal symptoms in neonates with should include: 1) immediate discontinuation of Monitor complete blood count in patients with third trimester exposure. Advise patients to antipsychotic drugs and other drugs not pre-existing low white blood cell count (WBC)/ notify their healthcare provider of a known or essential to concurrent therapy; 2) intensive absolute neutrophil count or
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