ACCESS & SUPPORT

Ordering & Reimbursement

Not an actual patient.

Ordering

Order ARISTADA® (aripiprazole lauroxil) and ARISTADA INITIO® (aripiprazole lauroxil) by contacting your wholesaler or distributor

Find an ARISTADA or ARISTADA INITIO wholesale order entry number below.

Wholesaler/ DistributorARISTADA INITIO 675 mg Item #ARISTADA 441 mg Item #ARISTADA 662 mg Item #ARISTADA 882 mg Item #ARISTADA 1064 mg Item #
ARISTADA NDC No.65757-500-03265757-0401-03365757-0402-03365757-0403-03365757-0404-033
AmerisourceBergen®1018876610158930101589071015890610178590
ANDA Inc.804692804348804349804350804531
API - Associated Pharmacies - Co-op500036640103040203040303704043
ASD Specialty Healthcare Inc/ Besse Medical1024209210241813102422801024329010242064
Cardinal Health®54649535161427516149251615675368352
Dakota Drug Inc. (DDI)390831262188262204262212312314
Louisiana Wholesale210237166165166173166181189589
McKesson39198003489051348906934890773670726
Morris & Dickson380865398776398834399311981852
N.C. Mutual Drug318949195024195032195040270538
R&S Northeast50003a40103a40203a40303a40403a
Smart-Fill - Co-op65757-500-0365757-401-0365757-402-0365757-403-0365757-404-03
Smith Drug/Burlington853168741918741900741926809780
Value Drug194844146044146048146046175878

Wholesaler/ Distributor:

ARISTADA NDC No.

ARISTADA INITIO 675 mg Item #:

65757-500-032

ARISTADA 441 mg Item #:

65757-0401-033

ARISTADA 662 mg Item #:

65757-0402-033

ARISTADA 882 mg Item #:

65757-0403-033

ARISTADA 1064 mg Item #:

65757-0404-033

Wholesaler/ Distributor:

AmerisourceBergen®

ARISTADA INITIO 675 mg Item #:

10188766

ARISTADA 441 mg Item #:

10158930

ARISTADA 662 mg Item #:

10158907

ARISTADA 882 mg Item #:

10158906

ARISTADA 1064 mg Item #:

10178590

Wholesaler/ Distributor:

ANDA Inc.

ARISTADA INITIO 675 mg Item #:

804692

ARISTADA 441 mg Item #:

804348

ARISTADA 662 mg Item #:

804349

ARISTADA 882 mg Item #:

804350

ARISTADA 1064 mg Item #:

804531

Wholesaler/ Distributor:

API - Associated Pharmacies - Co-op

ARISTADA INITIO 675 mg Item #:

500036

ARISTADA 441 mg Item #:

640103

ARISTADA 662 mg Item #:

040203

ARISTADA 882 mg Item #:

040303

ARISTADA 1064 mg Item #:

704043

Wholesaler/ Distributor:

ASD Specialty Healthcare Inc/ Besse Medical

ARISTADA INITIO 675 mg Item #:

10242092

ARISTADA 441 mg Item #:

10241813

ARISTADA 662 mg Item #:

10242280

ARISTADA 882 mg Item #:

10243290

ARISTADA 1064 mg Item #:

10242064

Wholesaler/ Distributor:

Cardinal Health®

ARISTADA INITIO 675 mg Item #:

5464953

ARISTADA 441 mg Item #:

5161427

ARISTADA 662 mg Item #:

5161492

ARISTADA 882 mg Item #:

5161567

ARISTADA 1064 mg Item #:

5368352

Wholesaler/ Distributor:

Dakota Drug Inc. (DDI)

ARISTADA INITIO 675 mg Item #:

390831

ARISTADA 441 mg Item #:

262188

ARISTADA 662 mg Item #:

262204

ARISTADA 882 mg Item #:

262212

ARISTADA 1064 mg Item #:

312314

Wholesaler/ Distributor:

Louisiana Wholesale

ARISTADA INITIO 675 mg Item #:

210237

ARISTADA 441 mg Item #:

166165

ARISTADA 662 mg Item #:

166173

ARISTADA 882 mg Item #:

166181

ARISTADA 1064 mg Item #:

189589

Wholesaler/ Distributor:

McKesson

ARISTADA INITIO 675 mg Item #:

3919800

ARISTADA 441 mg Item #:

3489051

ARISTADA 662 mg Item #:

3489069

ARISTADA 882 mg Item #:

3489077

ARISTADA 1064 mg Item #:

3670726

Wholesaler/ Distributor:

Morris & Dickson

ARISTADA INITIO 675 mg Item #:

380865

ARISTADA 441 mg Item #:

398776

ARISTADA 662 mg Item #:

398834

ARISTADA 882 mg Item #:

399311

ARISTADA 1064 mg Item #:

981852

Wholesaler/ Distributor:

N.C. Mutual Drug

ARISTADA INITIO 675 mg Item #:

318949

ARISTADA 441 mg Item #:

195024

ARISTADA 662 mg Item #:

195032

ARISTADA 882 mg Item #:

195040

ARISTADA 1064 mg Item #:

270538

Wholesaler/ Distributor:

R&S Northeast

ARISTADA INITIO 675 mg Item #:

50003a

ARISTADA 441 mg Item #:

40103a

ARISTADA 662 mg Item #:

40203a

ARISTADA 882 mg Item #:

40303a

ARISTADA 1064 mg Item #:

40403a

Wholesaler/ Distributor:

Smart-Fill - Co-op

ARISTADA INITIO 675 mg Item #:

65757-500-03

ARISTADA 441 mg Item #:

65757-401-03

ARISTADA 662 mg Item #:

65757-402-03

ARISTADA 882 mg Item #:

65757-403-03

ARISTADA 1064 mg Item #:

65757-404-03

Wholesaler/ Distributor:

Smith Drug/Burlington

ARISTADA INITIO 675 mg Item #:

853168

ARISTADA 441 mg Item #:

741918

ARISTADA 662 mg Item #:

741900

ARISTADA 882 mg Item #:

741926

ARISTADA 1064 mg Item #:

809780

Wholesaler/ Distributor:

Value Drug

ARISTADA INITIO 675 mg Item #:

194844

ARISTADA 441 mg Item #:

146044

ARISTADA 662 mg Item #:

146048

ARISTADA 882 mg Item #:

146046

ARISTADA 1064 mg Item #:

175878

aNot stocked but will order on demand.

Discover pricing and ordering

Explore pricing and ordering information for ARISTADA and ARISTADA INITIO with the Dosing and Pharmacy Ordering Brochure.

Download the Brochure

Learn more about pricing with the Provider Pricing Fact Sheet

Direct-purchase discounts are available to eligible providers through the Alkermes distribution partner, Besse Medical.b

Download Provider Pricing Fact Sheet

bContact Besse Medical regarding eligibility for program pricing.

Billing & Coding

Billing Information and Codes for ARISTADA and ARISTADA INITIO

The information below is provided to help support coding and billing for patients with schizophrenia who are being treated with ARISTADA INITIO and/or ARISTADA.

Field/Category NameExample - ARISTADA INITIOcExample - ARISTADAc
Procedures, services, or supplies (eg, HCPCS code)J1943 - injection, aripiprazole lauroxil, (ARISTADA INITIO), 1 mgJ1944 - injection, aripiprazole lauroxil, (ARISTADA), 1 mg
Procedures, services, or supplies (eg, NDCs)ARISTADA INITIO 675 mg: NDC 65757-500-03

ARISTADA

441 mg: NDC 65757-401-03

662 mg: NDC 65757-402-03

882 mg: NDC 65757-403-03

1064 mg: NDC 65757-404-03

Procedures, services, or supplies (eg, CPT® coded)96372 therapeutic, prophylactic, diagnostic subcutaneous or intramuscular injectione96372 therapeutic, prophylactic, diagnostic subcutaneous or intramuscular injectione
Units675 units for 675 mg

441 units for 441 mg

662 units for 662 mg

882 units for 882 mg

1064 units for 1064 mg

Diagnosis or nature of illness or injury

F20.0 Paranoid schizophrenia

F20.1 Disorganized schizophrenia

F20.2 Catatonic schizophrenia

F20.3 Undifferentiated schizophrenia

F20.5 Residual schizophrenia

F20.89 Other schizophrenia

F20.9 Unspecified schizophrenia

F20.0 Paranoid schizophrenia

F20.1 Disorganized schizophrenia

F20.2 Catatonic schizophrenia

F20.3 Undifferentiated schizophrenia

F20.5 Residual schizophrenia

F20.89 Other schizophrenia

F20.9 Unspecified schizophrenia

Field/Category Name:

Procedures, services, or supplies (eg, HCPCS code)

Example - ARISTADA INITIOc:

J1943 - injection, aripiprazole lauroxil, (ARISTADA INITIO), 1 mg

Example - ARISTADAc:

J1944 - injection, aripiprazole lauroxil, (ARISTADA), 1 mg

Field/Category Name:

Procedures, services, or supplies (eg, NDCs)

Example - ARISTADA INITIOc:

ARISTADA INITIO 675 mg: NDC 65757-500-03

Example - ARISTADAc:

ARISTADA

441 mg: NDC 65757-401-03

662 mg: NDC 65757-402-03

882 mg: NDC 65757-403-03

1064 mg: NDC 65757-404-03

Field/Category Name:

Procedures, services, or supplies (eg, CPT® coded)

Example - ARISTADA INITIOc:

96372 therapeutic, prophylactic, diagnostic subcutaneous or intramuscular injectione

Example - ARISTADAc:

96372 therapeutic, prophylactic, diagnostic subcutaneous or intramuscular injectione

Field/Category Name:

Units

Example - ARISTADA INITIOc:

675 units for 675 mg

Example - ARISTADAc:

441 units for 441 mg

662 units for 662 mg

882 units for 882 mg

1064 units for 1064 mg

Field/Category Name:

Diagnosis or nature of illness or injury

Example - ARISTADA INITIOc:

F20.0 Paranoid schizophrenia

F20.1 Disorganized schizophrenia

F20.2 Catatonic schizophrenia

F20.3 Undifferentiated schizophrenia

F20.5 Residual schizophrenia

F20.89 Other schizophrenia

F20.9 Unspecified schizophrenia

Example - ARISTADAc:

F20.0 Paranoid schizophrenia

F20.1 Disorganized schizophrenia

F20.2 Catatonic schizophrenia

F20.3 Undifferentiated schizophrenia

F20.5 Residual schizophrenia

F20.89 Other schizophrenia

F20.9 Unspecified schizophrenia

CPT®=Current Procedural Terminology. CPT® is a registered trademark of the American Medical Association.

 

cAll examples indicated should also include any placeholder digits required by the 837P format.

dThis code is not intended to be reported by the healthcare provider in the facility setting.

eARISTADA INITIO and ARISTADA are only to be administered as an intramuscular injection by a healthcare provider.2,3

 

Coding decisions should be made by the healthcare provider based on an independent review of the patient's condition.

Explore the Coding and Billing Guide to learn more
Download the Coding and Billing Guide

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. Healthcare providers also are responsible for the accuracy of all claims and related documentation submitted for 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. Alkermes does not guarantee coverage or reimbursement. 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.

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References: 1. Data on file. Alkermes, Inc. 2. ARISTADA INITIO. Package insert. Alkermes, Inc. 3. ARISTADA. Package insert. Alkermes, Inc.

INDICATION AND IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

ARI HCP ISI

Important Safety Information for ARISTADA HCP Website

Indication Section

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.

ISI Section Title

IMPORTANT SAFETY INFORMATION

Boxed Warning

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.

ISI Copy

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 1-866-274-7823 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

Prescription Information

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

ARI HCP ISI

Important Safety Information for ARISTADA HCP Website

Boxed Warning

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.

ISI Copy

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 1-866-274-7823 or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.

Prescription Information

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

Indication Section

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.

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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.