ARISTADA aripiprazole lauroxil 441 mg/1.6mL Injection, Suspension, Extended Release, 1 syringe

1 INDICATIONS AND USAGE ARISTADA is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).

2 DOSAGE AND ADMINISTRATION Administer ARISTADA by intramuscular injection in the deltoid (441 mg dose only) or gluteal (441 mg, 662 mg, 882 mg or 1064 mg) muscle by a healthcare professional ( 2.1 ). For patients naïve to aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA ( 2.1 ). There are two options for initiating treatment with ARISTADA: Option #1: Administer one injection of 675 mg of ARISTADA INITIO ® and one 30 mg dose of oral aripiprazole in conjunction with the first ARISTADA injection.

( 2.1 ). Option #2: Administer 21 consecutive days of oral aripiprazole in conjunction with the first ARISTADA injection ( 2.1 ). ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg dose every 6 weeks, or 1064 mg dose every 2 months ( 2.1 ).

Dosing regimen adjustments may be required for missed doses ( 2.2 ). Dose adjustments are required for 1) known CYP2D6 poor metabolizers and 2) for patients taking CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers for more than 2 weeks ( 2.4 ).

2.1Recommended Dosage ARISTADA is only to be administered as an intramuscular injection by a healthcare professional. For patients who have never taken aripiprazole, establish tolerability with oral aripiprazole prior to initiating treatment with ARISTADA. Due to the half-life of oral aripiprazole, it may take up to 2 weeks to fully assess tolerability.

Refer to the prescribing information of oral aripiprazole for the recommended dosage and administration of the oral formulation. There are two ways to initiate treatment with ARISTADA: Option #1: Administer one intramuscular injection of ARISTADA INITIO 675 mg (in either the deltoid or gluteal muscle) and one dose of oral aripiprazole 30 mg in conjunction with the first ARISTADA injection. The first ARISTADA injection may be administered on the same day as ARISTADA INITIO or up to 10 days thereafter.

See the ARISTADA INITIO prescribing information for additional information regarding administration of ARISTADA INITIO. Avoid injecting both ARISTADA INITIO and ARISTADA concomitantly into the same deltoid or gluteal muscle. Option #2: Administer 21 consecutive days of oral aripiprazole in conjunction with the first ARISTADA injection.

Depending on individual patient's needs, treatment with ARISTADA can be initiated at a dose of 441 mg, 662 mg or 882 mg administered monthly, 882 mg administered every 6 weeks or 1064 mg administered every 2 months. The 441 mg, 662 mg, 882 mg and 1064 mg doses correspond to 300 mg, 450 mg, 600 mg and 724 mg of aripiprazole, respectively [see Clinical Pharmacology ( 12.3 )]. Table 1: ARISTADA Dosing Frequency and Site of Injection Dose Dosing Frequency Site of Intramuscular Injection 441 mg Monthly Deltoid or Gluteal 662 mg Monthly Gluteal 882 mg Monthly or every 6 weeks Gluteal 1064 mg Every 2 months Gluteal Use the following ARISTADA doses for patients who are stabilized on oral aripiprazole, as shown in Table 2 .

Table 2: ARISTADA Doses Based on Oral Aripiprazole Total Daily Dose Oral Aripiprazole Dose Intramuscular ARISTADA Dose 10 mg per day 441 mg every month 15 mg per day 662 mg every month 882 mg every 6 weeks 1064 mg every 2 months 20 mg or higher per day 882 mg every month In conjunction with the first ARISTADA injection, administer a single injection of ARISTADA INITIO and one dose of oral aripiprazole 30 mg, or continue treatment with oral aripiprazole for 21 consecutive days [see Recommended Dosage ( 2.1 )]. Adjust the ARISTADA dose as needed.

When making dose and dosing interval adjustments, consider the pharmacokinetics and prolonged-release characteristics of ARISTADA [see Clinical Pharmacology ( 12.3 )].

2.2Missed Doses When a dose of ARISTADA is missed, administer the next injection of ARISTADA as soon as possible. Depending on the time elapsed since the last ARISTADA injection, supplement the next ARISTADA injection as recommended in Table 3 below. Table 3: Reco…

3 DOSAGE FORMS AND STRENGTHS ARISTADA is a white to off-white aqueous extended-release injectable suspension provided in a single-dose pre-filled syringe. ARISTADA is available as described in Table 6 . Table 6: Presentations of ARISTADA Dose Strength Volume Inject Intramuscularly Color Label 441 mg 1.6 mL Deltoid or Gluteal Muscle Light Blue 662 mg 2.4 mL Gluteal Muscle Only Green 882 mg 3.2 mL Gluteal Muscle Only Burgundy 1064 mg 3.9 mL Gluteal Muscle Only Dark Blue Extended-release injectable suspension: 441 mg, 662 mg, 882 mg or 1064 mg single-dose pre-filled syringe ( 3 )

17 PATIENT COUNSELING INFORMATION Advise patients to read FDA-approved patient labeling ( Medication Guide ). Pathological Gambling and Other Compulsive Behaviors Advise patients and their caregivers of the possibility that they may experience compulsive urges to shop, intense urges to gamble, compulsive sexual urges, binge eating and/or other compulsive urges and the inability to control these urges. In some cases, but not all, the urges were reported to have stopped when the dose was reduced or stopped [see Warnings and Precautions ( 5.7 )] .

Neuroleptic Malignant Syndrome Counsel patients about a potentially fatal adverse reaction referred to as NMS that has been reported in association with administration of antipsychotic drugs. Advise patients to contact a healthcare provider or report to the emergency room if they experience signs or symptoms of NMS [see Warnings and Precautions ( 5.4 )]. Tardive Dyskinesia Advise patients that abnormal involuntary movements have been associated with administration of antipsychotic drugs.

Counsel patients to notify their healthcare provider if they notice any movements which they cannot control in their face, tongue, or other body part [see Warnings and Precautions ( 5.5 )]. Metabolic Changes (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain) Educate patients about the risk of metabolic changes, how to recognize symptoms of hyperglycemia and diabetes mellitus, and the need for specific monitoring, including blood glucose, lipids, and weight [see Warnings and Precautions ( 5.6 )]. Orthostatic Hypotension Educate patients about the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing), particularly at the time of initiating treatment, re-initiating treatment, or increasing the dose [see Warnings and Precautions ( 5.8 )].

Falls Advise patients and their caregivers of the possibility that they may experience somnolence, postural hypotension, or motor and sensory instability, which may lead to the risk of falls, particularly in patients with diseases, conditions, or medications that could exacerbate these effects [see Warnings and Precautions ( 5.9 )] . Leukopenia/ Neutropenia Advise patients with a pre-existing low WBC count or a history of drug-induced leucopenia/neutropenia that they should have their CBC monitored while receiving ARISTADA [see Warnings and Precautions ( 5.10 )].

Interference with Cognitive and Motor Performance Because ARISTADA may have the potential to impair judgment, thinking or motor skills, instruct patients to be cautious about operating hazardous machinery, including automobiles, until they are reasonably certain that ARISTADA therapy does not affect them adversely [see Warnings and Precautions ( 5.12 )]. Heat Exposure and Dehydration Advise patients regarding appropriate care in avoiding overheating and dehydration [see Warnings and Precautions ( 5.13 )]. Concomitant Medication Advise patients to inform their physicians if they are taking, or plan to take, any prescription or over-the-counter drugs, since there is a potential for interactions [see Drug Interactions ( 7 )].

Pregnancy Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with ARISTADA. Advise patients that ARISTADA may cause extrapyramidal and/or withdrawal symptoms (agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder) in a neonate. Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to ARISTADA during pregnancy [see Use in Specific Populations ( 8.1 )].

Lactation ARISTADA use during pregnancy may affect milk supply. Advise the lactating patient to discuss any plans for breastfeeding with their healthcare provider, and to monitor the breastfed infant for dehydration and lack of appropriate weight gain [see Use in Specific Populations ( 8.2 )]. For additional information, visit www.AR…

This Medication Guide has been approved by the U.S. Food and Drug Administration Revised 12/2023 MEDICATION GUIDE ARISTADA ® (air-is-TAH-dah) (aripiprazole lauroxil) extended-release injectable suspension, for intramuscular use What is the most important information I should know about ARISTADA? Each injection of ARISTADA must be administered by a healthcare professional only.

ARISTADA may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis . ARISTADA increases the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ARISTADA is not for the treatment of people with dementia-related psychosis.

What is ARISTADA? ARISTADA is a prescription medicine used to treat schizophrenia in adults. It is not known if ARISTADA is safe and effective in children under 18 years of age.

Do not receive ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. See the end of this Medication Guide for a complete list of ingredients in ARISTADA. Before receiving ARISTADA, tell your healthcare provider about all of your medical conditions, including if you: have never taken ABILIFY ® , ABILIFY MAINTENA ® or any aripiprazole product before have or had heart problems or a stroke have diabetes or high blood sugar or a family history of diabetes or high blood sugar.

Your healthcare provider should check your blood sugar before you start receiving ARISTADA and during your treatment. have or had low or high blood pressure have or had seizures (convulsions) have or had a low white blood cell count have problems that may affect you receiving an injection in your buttocks or your arm are pregnant or plan to become pregnant. It is not known if ARISTADA will harm your unborn baby. If you become pregnant while receiving ARISTADA, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics.

You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/ are breastfeeding or plan to breastfeed. ARISTADA can pass into your breast milk and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ARISTADA.

Tell your healthcare provider about all the medicines you take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARISTADA and other medicines may affect each other causing possible serious side effects. ARISTADA may affect the way other medicines work, and other medicines may affect how ARISTADA works.

Your healthcare provider can tell you if it is safe to receive ARISTADA with your other medicines. Do not start or stop any medicines while receiving ARISTADA without talking to your healthcare provider first. How should I receive ARISTADA?

Follow your ARISTADA treatment schedule exactly as your healthcare provider tells you to. Each ARISTADA is an injection given by your healthcare provider into the muscle (intramuscular) of your arm or buttock. There are 2 ways to start treatment with ARISTADA: Option 1 : You will receive 1 dose of ARISTADA INITIO in combination with a single dose of oral aripiprazole.

You may also receive your first injection of ARISTADA on the same day you receive ARISTADA INITIO or up to 10 days after you receive ARISTADA INITIO. Option 2 : After your first injection of ARISTADA, you will take oral aripiprazole for 21 days in a row (consecutive). You should not miss a dose of ARISTADA.

If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next. What should I avoid while receiving ARISTADA? Do not drive a car, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA affects you.

ARISTADA may affect your judgment, thinking or motor skills. Avoid becoming too hot or dehydrated whil…