b'B:16"T:15.75"S:14.875"AVAILABLE ON THE VA NATIONAL FORMULARY* IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO AND ARISTADA (continued)30Contraindication: Known hypersensitivity reaction to aripiprazole.Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, Reactions have ranged from pruritus/urticaria to anaphylaxis.neutropenia and agranulocytosis have been reported with antipsychotics. Cerebrovascular Adverse Reactions, Including Stroke: IncreasedMonitor complete blood count in patients with pre-existing low white For adults with schizophrenia incidence of cerebrovascular adverse reactions (e.g., stroke, transientblood cell count (WBC)/absolute neutrophil count or history of ischemic attack), including fatalities, have been reported in placebo- drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO Give me treatmentcontrolled trials of elderly patients with dementia-related psychosisand/or ARISTADA at the first sign of a clinically significant decline in treated with risperidone, aripiprazole, and olanzapine. ARISTADAWBC and in severely neutropenic patients. INITIO and ARISTADA are not approved for the treatment of patientsSeizures: Use with caution in patients with a history of seizures that starts strongwith dementia-related psychosis.or with conditions that lower the seizure threshold. Potential for Dosing and Medication Errors: Medication errors,Potential for Cognitive and Motor Impairment: ARISTADA INITIO and including substitution and dispensing errors, between ARISTADAARISTADA may impair judgment, thinking, or motor skills. Patients and stays strong INITIO and ARISTADA could occur. ARISTADA INITIO is intended forshould be cautioned about operating hazardous machinery, including single administration in contrast to ARISTADA which is administeredautomobiles, until they are certain therapy with ARISTADA INITIO and/monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADAor ARISTADA does not affect them adversely. INITIO for ARISTADA because of differing pharmacokinetic profiles. Body Temperature Regulation: Disruption of the bodys ability to ARISTADA IS PROVEN EFFECTIVE 1 Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptomreduce core body temperature has been attributed to antipsychoticcomplex may occur with administration of antipsychotic drugs, includingagents. Advise patients regarding appropriate care in avoiding START STRONG WITH ARISTADA INITIO SINGLE-DAY INITIATION 1,2 ARISTADA INITIO and ARISTADA. Clinical manifestations of NMS includeoverheating and dehydration. Appropriate care is advised for patients hyperpyrexia, muscle rigidity, altered mental status, and evidence ofwho may exercise strenuously, may be exposed to extreme heat,autonomic instability (irregular pulse or blood pressure, tachycardia,receive concomitant medication with anticholinergic activity, or are STAY STRONG WITH THE ARISTADA 2-MONTH DOSE (1064 MG) 1a diaphoresis, and cardiac dysrhythmia). Additional signs may includesubject to dehydration.a elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), andDysphagia: Esophageal dysmotility and aspiration have been Additional dosing options are available:acute renal failure. The management of NMS should include: 1) associated with antipsychotic drug use; use caution in patients at risk 441 mg monthly, 662 mg monthly, andimmediate discontinuation of antipsychotic drugs and other drugs notfor aspiration pneumonia. 882 mg monthly or every 6 weeks. essential to concurrent therapy; 2) intensive symptomatic treatment and medical monitoring; and 3) treatment of any concomitant seriousConcomitant Medication: ARISTADA INITIO is only available at medical problems for which specific treatments are available.a single strength as a single-dose pre-filled syringe, so dosage Important dosing considerations forTardive Dyskinesia (TD): The risk of developing TD (a syndrome ofadjustments are not possible. Avoid use in patients who are known ARISTADA INITIO and ARISTADA abnormal, involuntary movements) and the potential for it to becomeCYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong irreversible are believed to increase as the duration of treatment andCYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs For patients who have never taken aripiprazole,the total cumulative dose of antipsychotic increase. The syndrome canor benzodiazepines. establish tolerability with oral aripiprazole priordevelop, although much less commonly, after relatively brief treatmentDepending on the ARISTADA dose, adjustments may be recommended to initiating ARISTADA or ARISTADA INITIO 1,2 periods at low doses. Prescribing antipsychotics should be consistentif patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking ARISTADA INITIO and ARISTADA are only to bewith the need to minimize TD. Discontinue ARISTADA if clinicallystrong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 administered as an intramuscular injection by aJulian, appropriate. TD may remit, partially or completely, if antipsychoticinducers for greater than 2 weeks. Avoid use of ARISTADA 662 mg, healthcare professional 1,2 treated withtreatment is withdrawn.882 mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors ARISTADA everyand strong CYP2D6 inhibitors. (See Table 4 in the ARISTADA full There are 2 ways to start treatment withMetabolic Changes: Atypical antipsychotic drugs have been associatedPrescribing Information.)ARISTADA. If not starting ARISTADA with the2 months (1064 mg) with metabolic changes that include: ARISTADA INITIO regimen, administerHyperglycemia/Diabetes Mellitus: Hyperglycemia, in some casesCommonly Observed Adverse Reactions: In pharmacokinetic studiesS:10" T:10.75" B:11"21 consecutive days of oral aripiprazoleextreme and associated with ketoacidosis, coma, or death, hasthe safety profile of ARISTADA INITIO was generally consistent with with the first ARISTADA injection been reported in patients treated with atypical antipsychotics.that observed for ARISTADA. The most common adverse reaction (5% There have been reports of hyperglycemia in patients treated withincidence and at least twice the rate of placebo reported by patients Adjust ARISTADA dose as needed. When makingoral aripiprazole. Patients with diabetes should be regularlytreated with ARISTADA 441 mg and 882 mg monthly) was akathisia.dose and dosing interval adjustments, considermonitored for worsening of glucose control; those with risk factorsInjection-Site Reactions: In pharmacokinetic studies evaluating the pharmacokinetics and prolonged-releasefor diabetes should undergo baseline and periodic fasting bloodARISTADA INITIO, the incidences of injection-site reactions with characteristics of ARISTADA. ARISTADA INITIO is a single dose, and adjustments are not possible 1,2 Learn more about the treatmentglucose testing. Any patient treated with atypical antipsychoticsARISTADA INITIO were similar to the incidence observed with should be monitored for symptoms of hyperglycemia, includingARISTADA. Injection-site reactions were reported by 4%, 5%, and 2% of When any dose of ARISTADA is missed,experiences of real patients atpolydipsia, polyuria, polyphagia, and weakness. Patients whopatients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA administer the next injection as soon as possible.develop symptoms of hyperglycemia should also undergo fasting(monthly), and placebo, respectively. Most of these were injection-site Concomitant supplementation following a missedaristadahcp.com/patient-stories. blood glucose testing. In some cases, hyperglycemia has resolvedpain and associated with the first injection and decreased with each dose may be recommended depending on thewhen the atypical antipsychotic was discontinued; however, somesubsequent injection. Other injection-site reactions (induration, time elapsed since the last injection. See the fullpatients require continuation of antidiabetic treatment despiteswelling, and redness) occurred at less than 1%. Prescribing Information for more information discontinuation of the suspect drug. Dystonia: Symptoms of dystonia, prolonged abnormal contractions of Safety and effectiveness of ARISTADA in patientsDyslipidemia: Undesirable alterations in lipids have been observedmuscle groups, may occur in susceptible individuals during the first 65 years of age have not been evaluated in patients treated with atypical antipsychotics.days of treatment and at low doses. Weight Gain: Weight gain has been observed with atypicalPregnancy/Nursing: May cause extrapyramidal and/or withdrawal * See Important Coverage Disclaimer atantipsychotic use. Clinical monitoring of weight is recommended. symptoms in neonates with third trimester exposure. Advise patients https://www.aristadahcp.com/access-support Pathological Gambling and Other Compulsive Behaviors: Compulsiveto notify their healthcare provider of a known or suspected pregnancy. or uncontrollable urges to gamble have been reported with use ofInform patients that there is a pregnancy exposure registry that aripiprazole. Other compulsive urges less frequently reported includemonitors pregnancy outcomes in women exposed to ARISTADA INITIO sexual urges, shopping, binge eating and other impulsive or compulsiveand/or ARISTADA during pregnancy. Aripiprazole is present in human behaviors which may result in harm for the patient and others if notbreast milk. The benefits of breastfeeding should be considered along recognized. Closely monitor patients and consider dose reduction orwith the mothers clinical need for ARISTADA INITIO and/or ARISTADA stopping aripiprazole if a patient develops such urges. and any potential adverse effects on the infant from ARISTADA INITIO Orthostatic Hypotension: Aripiprazole may cause orthostaticand/or ARISTADA or from the underlying maternal condition. INDICATION hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warnPlease see the Brief Summaries of full Prescribing ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for thepatients with known cardiovascular or cerebrovascular disease and riskInformation, including Boxed Warning, for ARISTADA treatment of schizophrenia in adults. of dehydration and syncope.INITIO and ARISTADA on the following pages. ARISTADA is indicated for the treatment of schizophrenia in adults.Falls: Antipsychotics including ARISTADA INITIO and ARISTADA may cause somnolence, postural hypotension or motor and sensory References: 1. ARISTADA [package insert]. Waltham, MA: Alkermes, Inc; 2021. IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO AND ARISTADA instability which may lead to falls and subsequent injury. Upon initiating2. ARISTADA INITIO [package insert]. Waltham, MA: Alkermes, Inc; 2021.treatment and recurrently, complete fall risk assessments as appropriate.BOXED WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISElderly 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.ALKERMES is a registered trademark of Alkermes, Inc. ARISTADA and logo, Please see additional Important Safety Information and Brief Summaries of full Prescribingand ARISTADA INITIO, are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc., under license. 2022 Alkermes, Inc. All rights Information, including Boxed Warning, for ARISTADA INITIO and ARISTADA on the following pages. reserved. ARI-004778 Printed in the U.S.A. July 2022FS:7" FS:7"F:7.875" F:7.875"'