Join us for this Alkermes-hosted Product Theater

Schizophrenia: Treating a Complex Condition with a New Long-acting Injectable (LAI)

Monday May 16, 2016 11:00 AM to 12:00 PM Gustavo Alva, MD, DFAPA Henry Nasrallah, MD Lunch will be served Medical Director, Professor & Chairman, ATP Clinical Research Department of Neurology and Psychiatry Pacific Neuropsychiatric Specialists St. Louis University School of Medicine Product Theater 1, Costa Mesa, CA St. Louis, MO Booth 113 Georgia World Congress Center Atlanta, GA

This program is sponsored by Alkermes, Inc. Gustavo Alva, MD, DFAPA, and Henry Nasrallah, MD, are paid consultants of Alkermes, Inc. Guests and spouses of attendees may not attend the presentation or any meals associated with the presentation. Restrictions for food, drinks and educational items Due to state laws, healthcare practitioners licensed in certain states (eg, Vermont) may not be eligible to receive food, drinks or educational items that may be provided. Government employees may be subject to laws, regulations or rules that prohibit or limit receipt of gifts, meals and items of value provided by third parties. We ask that government employees comply with any such laws, regulations or rules. Public Disclosure Alkermes, Inc. may publicly disclose attendees’ information and the value of any food, drink, educational item or any other item of value provided to attendees in connection with this program in order to comply with regulatory and legal requirements. The industry product theater’s content and the views expressed therein are those of the supporting Please see Important Safety Information, company and not of APA or APF. This program does not provide CME credits. including Boxed Warning below.

INDICATION Metabolic Changes: Atypical antipsychotic Body Temperature Regulation: Disruption ARISTADA is indicated for the drugs have been associated with of the body’s ability to reduce core body treatment of schizophrenia. metabolic changes that include: temperature has been attributed to antipsychotic agents. Advise patients 1 • Hyperglycemia/Diabetes Mellitus: IMPORTANT SAFETY INFORMATION Hyperglycemia, in some cases extreme and regarding appropriate care in avoiding associated with ketoacidosis, coma, or overheating and dehydration. Appropriate care is advised for patients who may WARNING: INCREASED death, has been reported in patients treated with atypical antipsychotics. There have exercise strenuously, may be exposed to MORTALITY IN ELDERLY been reports of hyperglycemia in patients extreme heat, receive concomitant PATIENTS WITH DEMENTIA- treated with oral aripiprazole. Patients medication with anticholinergic activity, RELATED PSYCHOSIS with diabetes should be regularly monitored or are subject to dehydration. Elderly patients with dementia-related for worsening of glucose control; those Dysphagia: Esophageal dysmotility and psychosis treated with antipsychotic with risk factors for diabetes should aspiration have been associated with drugs are at an increased risk of undergo baseline and periodic fasting blood antipsychotic drug use; use caution in death. ARISTADA is not approved glucose testing. Any patient treated patients at risk for aspiration pneumonia. with atypical antipsychotics should be for the treatment of patients with Concomitant Medication: Decreasing the monitored for symptoms of hyperglycemia, dementia-related psychosis. ARISTADA dosage is recommended in including polydipsia, polyuria, polyphagia, patients taking strong CYP3A4 inhibitors and weakness. Patients who develop and/or strong CYP2D6 inhibitors for Contraindication: Known hypersensitivity symptoms of hyperglycemia should also longer than 2 weeks. Increasing the reaction to aripiprazole. Reactions undergo fasting blood glucose testing. In ARISTADA dosage is recommended in have ranged from pruritus/urticaria some cases, hyperglycemia has resolved patients taking CYP3A4 inducers for to anaphylaxis. when the atypical antipsychotic was longer than 2 weeks. No ARISTADA discontinued; however, some patients Cerebrovascular Adverse Events, dosage changes are recommended for require continuation of antidiabetic Including Stroke: Increased incidence patients taking CYP450 modulators for treatment despite discontinuation of of cerebrovascular adverse reactions less than 2 weeks. (eg, stroke, transient ischemic attack), the suspect drug. Most Commonly Observed Adverse including fatalities, have been reported • Dyslipidemia: Undesirable alterations Reaction: The most common adverse in placebo-controlled trials of elderly in lipids have been observed in patients patients with dementia-related psychosis treated with atypical antipsychotics. reaction (≥5% incidence and at least treated with risperidone, aripiprazole, and twice the rate of placebo in patients • Weight Gain: Weight gain has been treated with ARISTADA) was akathisia. olanzapine. ARISTADA is not approved observed with atypical antipsychotic for the treatment of patients with use. Clinical monitoring of weight is Injection-Site Reactions: Injection-site dementia-related psychosis. recommended. reactions were reported by 4%, 5%, and Neuroleptic Malignant Syndrome (NMS): 2% of patients treated with 441 mg Orthostatic Hypotension: Aripiprazole ARISTADA, 882 mg ARISTADA, and A potentially fatal symptom complex may cause orthostatic hypotension sometimes referred to as NMS may occur placebo, respectively. Most of these which can be associated with dizziness, were injection-site pain and associated with administration of antipsychotic lightheadedness, and tachycardia. drugs, including ARISTADA. Clinical with the first injection and decreased Monitor heart rate and blood pressure with each subsequent injection. Other manifestations of NMS include and warn patients with known hyperpyrexia, muscle rigidity, altered injection-site reactions (induration, cardiovascular or cerebrovascular disease swelling, and redness) occurred at less mental status, and evidence of and risk of dehydration and syncope. autonomic instability (irregular pulse or than 1%. blood pressure, tachycardia, diaphoresis, Leukopenia, Neutropenia, and Dystonia: Symptoms of dystonia, and cardiac dysrhythmia). Additional Agranulocytosis: Leukopenia, prolonged abnormal contractions of signs may include elevated creatine neutropenia, and agranulocytosis have muscle groups, may occur in susceptible phosphokinase, myoglobinuria been reported. Patients with a history of individuals during the first days of clinically significant low white blood cell (rhabdomyolysis), and acute renal failure. treatment and at low doses. count (WBC)/absolute neutrophil count The management of NMS should include: (ANC) and history of drug-induced Pregnancy/Nursing: May cause 1) immediate discontinuation of leukopenia/neutropenia should have extrapyramidal and/or withdrawal antipsychotic drugs and other drugs not frequent complete blood count (CBC) symptoms in neonates with third essential to concurrent therapy; 2) during the first few months of receiving trimester exposure. Advise patients to intensive symptomatic treatment and ARISTADA. Consider discontinuation of notify their healthcare provider of a medical monitoring; and 3) treatment of ARISTADA at the first sign of a clinically known or suspected pregnancy. Inform any concomitant serious medical significant decline in WBC count in the patients that there is a pregnancy problems for which specific treatments absence of other causative factors. exposure registry that monitors are available. Monitor patients with clinically pregnancy outcomes in women exposed Tardive Dyskinesia (TD): The risk of significant neutropenia for fever or other to ARISTADA during pregnancy. developing TD (a syndrome of abnormal, symptoms or signs of infection and treat Aripiprazole is present in human breast involuntary movements) and the promptly if such symptoms or signs milk. The benefits of breastfeeding potential for it to become irreversible are occur. Discontinue ARISTADA in patients should be considered along with the believed to increase as the duration of with severe neutropenia (absolute mother’s clinical need for ARISTADA and treatment and the total cumulative dose neutrophil count <1000/mm3) and follow any potential adverse effects on the of antipsychotic increase. The syndrome their WBC until recovery. infant from ARISTADA or from the underlying maternal condition. can develop, although much less commonly, Seizures: ARISTADA should be used with after relatively brief treatment periods at caution in patients with a history of Please see FULL PRESCRIBING low doses. Prescribing should be consistent seizures or with conditions that lower the INFORMATION, including with the need to minimize TD. Discontinue seizure threshold. ARISTADA if clinically appropriate. There Boxed Warning, for ARISTADA. is no known treatment for established Potential for Cognitive and Motor TD, although the syndrome may remit, Impairment: ARISTADA may impair partially or completely, if antipsychotic judgment, thinking, or motor skills. treatment is withdrawn. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain ARISTADA does not affect them adversely.

Atypical long-acting injectable (LAI) therapies can be an effective but underutilized resource for the treatment of schizophrenia.2 The objective of this program will be to review a new treatment option for those living with this complex and challenging condition.

References: 1. Aristada [package insert]. Waltham, MA: Alkermes, Inc; 2015; 2. Weiden PJ. Psychiatric Annals. 2011;41:271-278. ©2016 Alkermes. ARI-001409 ALKERMES® is a registered trademark of Alkermes, Inc., and ARISTADA® is a registered trademark of Alkermes Pharma Ireland Limited used by Alkermes, Inc. under license. All Rights Reserved.