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Insights on Schizophrenia:
A Video Series

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Learn more about ARISTADA® and ARISTADA INITIO® from real healthcare professionals

Listen to Dr. Stahl talk about using ARISTADA® (aripiprazole lauroxil) to treat adult patients with schizophrenia.1

See how the ARISTADA 2-month (1064 mg) dose can reduce schizophrenia symptoms in adult patients1*

Watch Dr. Stahl walk through the pharmacokinetics of ARISTADA, highlighting key attributes, and learn why he considers prescribing ARISTADA INITIO and ARISTADA for his adult patients with schizophrenia. This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Stahl is a paid consultant of Alkermes, Inc.

Stephen M. Stahl, MD, PhD, DSc (Hon.)
Professor of Psychiatry and Neuroscience, University of California Riverside, and University of California San Diego Medical School
Honorary Fellow, University of Cambridge, United Kingdom
Editor-in-Chief, CNS Spectrums
Director of Psychopharmacology Services, California Department of State Hospitals

*For patients who have never taken oral aripiprazole, establish tolerability before starting treatment with ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA. Other ARISTADA doses include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks.1,2

Learn about the pharmacokinetic profiles of ARISTADA INITIO and ARISTADA

Watch Dr. Stahl describe the pharmacokinetic profiles of ARISTADA INITIO (aripiprazole lauroxil) and ARISTADA, (aripiprazole lauroxil) and how they impact dosing.

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Stahl, MD, PhD, DSc (Hon) is a paid consultant of Alkermes, Inc.

Watch Dr. Stahl's video about the pharmacokinetics of ARISTADA
Stephen M. Stahl, MD, PhD, DSc (Hon.)
Professor of Psychiatry and Neuroscience, University of California Riverside, and University of California San Diego Medical School
Honorary Fellow, University of Cambridge, United Kingdom
Editor-in-Chief, CNS Spectrums
Director of Psychopharmacology Services, California Department of State Hospitals

Explore the dosing and initiation options for ARISTADA

Watch Dr. Meyer discuss the dosing and initiation options when starting treatment with ARISTADA, in appropriate adult patients with schizophrenia.

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Meyer, MD is a paid consultant of Alkermes, Inc.

Watch Dr. Meyer's video about ARISTADA data and safety profile
Jonathan Meyer, MD
Voluntary Clinical Professor of Psychiatry
University of California, San Diego

Find out more about how ARISTADA was studied in adult patients with schizophrenia who transitioned from inpatient to outpatient care.

See Jeremy Schreiber, MSN, PMHNP-BC present data from the ALPINE active-controlled supportive study, which evaluated the efficacy and safety of the ARISTADA INITIO regimen and the ARISTADA 2-month dose (1064 mg) in patients who started treatment in the hospital and transitioned to outpatient care.3

This non-CME promotional program is sponsored by Alkermes, Inc., and Jeremy Schreiber, MSN, PMHNP-BC is a paid consultant of Alkermes, Inc.

Watch Jeremy Schreiber's video about the ALPINE study
Jeremy Schreiber, MSN, PMHNP-BC
Founder, CEO, and Psychiatric Mental Health Nurse Practitioner
Enlighten Health Care, LLC
Adjunct Faculty, West Liberty University, West Virginia

See how the ARISTADA 2-month (1064 mg) dose can reduce schizophrenia symptoms in adult patients1*

Watch Dr. Stahl walk through the pharmacokinetics of ARISTADA, highlighting key attributes, and learn why he considers prescribing ARISTADA INITIO and ARISTADA for his adult patients with schizophrenia.1,2

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Stahl is a paid consultant of Alkermes, Inc.

Watch Dr. Stahl's video about ARISTADA treatment
Stephen M. Stahl, MD, PhD, DSc (Hon.)
Professor of Psychiatry and Neuroscience, University of California Riverside, and University of California San Diego Medical School
Honorary Fellow, University of Cambridge, United Kingdom
Editor-in-Chief, CNS Spectrums
Director of Psychopharmacology Services, California Department of State Hospitals
*For patients who have never taken oral aripiprazole, establish tolerability before starting treatment with ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA. Other ARISTADA doses include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks.1,2

Insights about initiating ARISTADA

Watch this video featuring Dr. Jose Rey as he discusses some of the challenges of initiating LAIs and the options for initiating treatment with ARISTADA.1,2

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Rey is a paid consultant of Alkermes, Inc.

Watch Dr. Rey's video about initiating ARISTADA
Jose Rey, PharmD
Professor, Nova Southeastern University

Hear about ways to talk to patients about LAIs as a treatment option

Watch Dr. Rakesh Jain lead a panel of experts, including Dr. Bryce Reynolds and Nurse Practitioners Hara Oyedeji and Tarrah Holliday, as they exchange views on ways of discussing LAIs with patients.

This non-CME promotional program is sponsored by Alkermes, Inc., and the participants in the discussion are paid consultants of Alkermes, Inc.

Watch Dr. Jain's video about LAI's for schizophrenia
Rakesh Jain, MD, MPH
Clinical Professor, Texas Tech University
Hara Oyedeji, NP
Nurse Practitioner, Fortitude Behavioral Health, LLC
Tarrah Holliday, NP
Nurse Practitioner, Zion Behavioral Health Services
Bryce Reynolds, MD
Psychiatrist, Carolina Outreach ACTT Services

Learn about ARISTADA clinical trials

Watch Dr. Heather Luing’s presentation about the development, pharmacokinetics, and pivotal trial that led to the approval of ARISTADA.1

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Luing is a paid consultant of Alkermes, Inc.

Watch Dr. Luing's video about the ARISTADA pivotal trial
Heather Luing, MD
Medical Director, Florida Center for TMS, Flagler Hospital

Learn more about the 1064 mg 2-month dose of ARISTADA

Hear Dr. Andrew J. Cutler discuss LAIs and the ARISTADA 1064 mg 2-month treatment option for adult patients with schizophrenia.1*

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Cutler is a paid consultant of Alkermes, Inc.

Watch Dr. Cutler's video about treatment with ARISTADA
Andrew J. Cutler, MD
Chief Medical Officer at the Neuroscience Education Institute
Clinical Associate Professor of Psychiatry at SUNY Upstate Medical University
*For patients who have never taken oral aripiprazole, establish tolerability before starting treatment with ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA. Other ARISTADA doses include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks.1,2

See how an APRN introduces ARISTADA to her patients

Hear practicing Advanced Practice Registered Nurse (APRN) Georgia L. Stevens’ point of view on how she introduces the efficacy, safety, and administration of ARISTADA to adult patients with schizophrenia.3-5

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Stevens is a paid consultant of Alkermes, Inc.

Watch Dr. Stevens' video discussing how to talk to patients about ARISTADA
Georgia L. Stevens, PhD, APRN, PMHCNS BC

Watch an overview of efficacy, safety, and pharmacokinetics for ARISTADA INITIO and ARISTADA

See Dr. Meyer provide an overview of the efficacy and safety of ARISTADA INITIO and ARISTADA and why he considers prescribing the 2-month (1064 mg) dose* for his appropriate adult patients with schizophrenia.2-5

This non-CME promotional program is sponsored by Alkermes, Inc., and Dr. Meyer is a paid consultant of Alkermes, Inc.

Watch Dr. Meyer's video about dosing and initiation of ARISTADA
Jonathan M. Meyer, MD
Voluntary Clinical Professor of Psychiatry, University of California, San Diego
*For patients who have never taken oral aripiprazole, establish tolerability before starting treatment with ARISTADA INITIO® (aripiprazole lauroxil) and ARISTADA. Other ARISTADA doses include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks.1,2
See the clinical overview
Learn more about the 2-month dose (1064 mg)*

*Other dosing options available.

References: 1. ARISTADA. Package insert. Alkermes, Inc. 2. ARISTADA INITIO. Package insert. Alkermes, Inc. 3. Weiden PJ, Claxton A, Kunovac J, et al. Efficacy and safety of a 2-month formulation of aripiprazole lauroxil with 1-day initiation in patients hospitalized for acute schizophrenia transitioned to outpatient care: phase 3, randomized, double-blind, active-control ALPINE study. J Clin Psychiatry. 2020;81(3):19m13207. doi:10.4088/JCP.19m13207 4. Meltzer HY, Risinger R, Nasrallah HA, et al. A randomized double-blind, placebo-controlled trial of aripiprazole lauroxil in acute exacerbation of schizophrenia. J Clin Psychiatry. 2015;76(8):1085-1090. 5. Nasrallah HA, Aquila R, Du Y, Stanford AD, Claxton A, Weiden PJ. Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia. CNS Spectr. 2019;24(4):395-403.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO AND ARISTADA

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.

SCROLL FOR IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

BOXED 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.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular 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. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis.

Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur. ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. 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). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 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.

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 syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing antipsychotics should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. 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. 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 should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping aripiprazole if a patient develops such urges.

Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

Falls: Antipsychotics including ARISTADA INITIO and ARISTADA may cause somnolence, postural hypotension or motor and sensory instability which may lead to falls and subsequent injury. Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO and/or ARISTADA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain therapy with ARISTADA INITIO and/or ARISTADA does not affect them adversely.

Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

Concomitant Medication: ARISTADA INITIO is only available at a single strength as a single-dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines.

Depending on the ARISTADA dose, adjustments may be recommended if patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers for greater than 2 weeks. Avoid use of ARISTADA 662 mg, 882 mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors and strong CYP2D6 inhibitors. (See Table 4 in the ARISTADA full Prescribing Information.)

Commonly Observed Adverse Reactions: In pharmacokinetic studies the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA. The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia.

Injection Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA. Injection site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection site pain and associated with the first injection and decreased with each subsequent injection. Other injection site reactions (induration, swelling, and redness) occurred at less than 1%.

Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA INITIO and/or ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for ARISTADA INITIO and/or ARISTADA and any potential adverse effects on the infant from ARISTADA INITIO and/or ARISTADA or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-238-8008 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning, for ARISTADA INITIO and ARISTADA.

INDICATION

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ARISTADA INITIO AND ARISTADA

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.

SCROLL FOR IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

BOXED 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.

Contraindication: Known hypersensitivity reaction to aripiprazole. Reactions have ranged from pruritus/urticaria to anaphylaxis.

Cerebrovascular 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. ARISTADA INITIO and ARISTADA are not approved for the treatment of patients with dementia-related psychosis.

Potential for Dosing and Medication Errors: Medication errors, including substitution and dispensing errors, between ARISTADA INITIO and ARISTADA could occur. ARISTADA INITIO is intended for single administration in contrast to ARISTADA which is administered monthly, every 6 weeks, or every 8 weeks. Do not substitute ARISTADA INITIO for ARISTADA because of differing pharmacokinetic profiles.

Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex may occur with administration of antipsychotic drugs, including ARISTADA INITIO and ARISTADA. 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). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. 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.

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 syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses. Prescribing antipsychotics should be consistent with the need to minimize TD. Discontinue ARISTADA if clinically appropriate. TD may remit, partially or completely, if antipsychotic treatment is withdrawn.

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include:

  • Hyperglycemia/Diabetes Mellitus: Hyperglycemia, in some cases extreme and associated with ketoacidosis, coma, or death, has been reported in patients treated with atypical antipsychotics. There have been reports of hyperglycemia in patients treated with oral aripiprazole. 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. 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 should also undergo fasting blood glucose testing. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients require continuation of antidiabetic treatment despite discontinuation of the suspect drug.
  • Dyslipidemia: Undesirable alterations in lipids have been observed in patients treated with atypical antipsychotics.
  • Weight Gain: Weight gain has been observed with atypical antipsychotic use. Clinical monitoring of weight is recommended.

Pathological Gambling and Other Compulsive Behaviors: Compulsive or uncontrollable urges to gamble have been reported with use of aripiprazole. Other compulsive urges less frequently reported include sexual urges, shopping, binge eating and other impulsive or compulsive behaviors which may result in harm for the patient and others if not recognized. Closely monitor patients and consider dose reduction or stopping aripiprazole if a patient develops such urges.

Orthostatic Hypotension: Aripiprazole may cause orthostatic hypotension which can be associated with dizziness, lightheadedness, and tachycardia. Monitor heart rate and blood pressure, and warn patients with known cardiovascular or cerebrovascular disease and risk of dehydration and syncope.

Falls: Antipsychotics including ARISTADA INITIO and ARISTADA may cause somnolence, postural hypotension or motor and sensory instability which may lead to falls and subsequent injury. Upon initiating treatment and recurrently, complete fall risk assessments as appropriate.

Leukopenia, Neutropenia, and Agranulocytosis: Leukopenia, neutropenia and agranulocytosis have been reported with antipsychotics. Monitor complete blood count in patients with pre-existing low white blood cell count (WBC)/absolute neutrophil count or history of drug-induced leukopenia/neutropenia. Discontinue ARISTADA INITIO and/or ARISTADA at the first sign of a clinically significant decline in WBC and in severely neutropenic patients.

Seizures: Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold.

Potential for Cognitive and Motor Impairment: ARISTADA INITIO and ARISTADA may impair judgment, thinking, or motor skills. Patients should be cautioned about operating hazardous machinery, including automobiles, until they are certain therapy with ARISTADA INITIO and/or ARISTADA does not affect them adversely.

Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents. Advise patients regarding appropriate care in avoiding overheating and dehydration. Appropriate care is advised for patients who may exercise strenuously, may be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or are subject to dehydration.

Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use; use caution in patients at risk for aspiration pneumonia.

Concomitant Medication: ARISTADA INITIO is only available at a single strength as a single-dose pre-filled syringe, so dosage adjustments are not possible. Avoid use in patients who are known CYP2D6 poor metabolizers or taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers, antihypertensive drugs or benzodiazepines.

Depending on the ARISTADA dose, adjustments may be recommended if patients are 1) known as CYP2D6 poor metabolizers and/or 2) taking strong CYP3A4 inhibitors, strong CYP2D6 inhibitors, or strong CYP3A4 inducers for greater than 2 weeks. Avoid use of ARISTADA 662 mg, 882 mg, or 1064 mg for patients taking both strong CYP3A4 inhibitors and strong CYP2D6 inhibitors. (See Table 4 in the ARISTADA full Prescribing Information.)

Commonly Observed Adverse Reactions: In pharmacokinetic studies the safety profile of ARISTADA INITIO was generally consistent with that observed for ARISTADA. The most common adverse reaction (≥5% incidence and at least twice the rate of placebo reported by patients treated with ARISTADA 441 mg and 882 mg monthly) was akathisia.

Injection Site Reactions: In pharmacokinetic studies evaluating ARISTADA INITIO, the incidences of injection site reactions with ARISTADA INITIO were similar to the incidence observed with ARISTADA. Injection site reactions were reported by 4%, 5%, and 2% of patients treated with 441 mg ARISTADA (monthly), 882 mg ARISTADA (monthly), and placebo, respectively. Most of these were injection site pain and associated with the first injection and decreased with each subsequent injection. Other injection site reactions (induration, swelling, and redness) occurred at less than 1%.

Dystonia: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first days of treatment and at low doses.

Pregnancy/Nursing: May cause extrapyramidal and/or withdrawal symptoms in neonates with third trimester exposure. Advise patients to notify their healthcare provider of a known or suspected pregnancy. Inform patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to ARISTADA INITIO and/or ARISTADA during pregnancy. Aripiprazole is present in human breast milk. The benefits of breastfeeding should be considered along with the mother’s clinical need for ARISTADA INITIO and/or ARISTADA and any potential adverse effects on the infant from ARISTADA INITIO and/or ARISTADA or from the underlying maternal condition.

To report SUSPECTED ADVERSE REACTIONS, contact Alkermes at 1-888-238-8008 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

Please see full Prescribing Information, including Boxed Warning, for ARISTADA INITIO and ARISTADA.

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