What is the most important information I should know about ARISTADA INITIO and ARISTADA?

Each injection of ARISTADA must be administered by a healthcare professional only. ARISTADA INITIO and ARISTADA may cause serious side effects, including increased risk of death in elderly people with dementia-related psychosis. ARISTADA INITIO and ARISTADA increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ARISTADA INITIO and ARISTADA are not for the treatment of people with dementia-related psychosis.

Who should not receive ARISTADA INITIO and ARISTADA?

Do not receive ARISTADA INITIO or ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA INITIO and ARISTADA. See the Medication Guides for ARISTADA INITIO and ARISTADA for a complete list of ingredients.

What should I tell my doctor before receiving ARISTADA INITIO and ARISTADA?

Tell your healthcare provider about all of your medical conditions, including if you: have not 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 receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA 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 INITIO and/or ARISTADA will harm your unborn baby. If you become pregnant while receiving ARISTADA INITIO and/or 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 INITIO and/or ARISTADA can pass into your breast milk and it is not known if they may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ARISTADA INITIO and ARISTADA

Should I tell my doctor about other medicines I take?

Yes. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO, ARISTADA, and other medicines may affect each other causing possible serious side effects. ARISTADA INITIO and ARISTADA may affect the way other medicines work, and other medicines may affect how ARISTADA INITIO and ARISTADA work. Your healthcare provider can tell you if it is safe to receive ARISTADA INITIO and ARISTADA with your other medicines. Do not start or stop any medicines while receiving ARISTADA INITIO and ARISTADA without talking to your healthcare provider first.

How will I receive ARISTADA INITIO?

Follow your ARISTADA INITIO treatment schedule exactly as your healthcare provider tells you to ARISTADA INITIO is a one-time injection given by your healthcare provider, into the muscle (intramuscular) of your arm or buttock ARISTADA INITIO is given 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 ARISTADA INITIO should only be used as a one-time dose to start ARISTADA treatment or to re-start ARISTADA treatment after a missed dose; ARISTADA INITIO is not meant for repeated dosing

How should I receive ARISTADA?

Follow your ARISTADA treatment schedule exactly as your healthcare provider tells you to Each ARISTADA dose 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 INITIO and ARISTADA?

Do not drive a car, operate machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you; ARISTADA INITIO and ARISTADA may affect your judgment, thinking or motor skills Avoid becoming too hot or dehydrated Do not exercise too much In hot weather, stay inside in a cool place if possible Stay out of the sun Do not wear too much clothing or heavy clothing Drink plenty of water

What are the ingredients in ARISTADA INITIO?

Active ingredient: aripiprazole lauroxil Inactive ingredients: polysorbate 20, sodium chloride, sodium citrate dihydrate, sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, and water for injection

What are the ingredients in ARISTADA?

Active ingredient: aripiprazole lauroxil Inactive ingredients: sorbitan monolaurate, polysorbate 20, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic dihydrate, and water for injection

General information about the safe and effective use of ARISTADA INITIO and ARISTADA

If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ARISTADA INITIO and ARISTADA that is written for health professionals.

How much will I save?

If you have commercial insurance, Alkermes may be able to help reduce your co-pay to as low as $10 per fill. Maximum savings per fill is $800 for ARISTADA 441 mg , 662 mg, and 882 mg up to 12 fills per calendar year, with maximum savings up to $7600 per calendar year. Maximum savings per fill is $1600 for ARISTADA 1064 mg up to 6 fills per calendar year, with maximum savings up to $7600 per calendar year. Minimum out-of-pocket cost per fill, after co-pay savings applied, is $10. For ARISTADA INITIO, maximum savings is up to $2000 total, and co-pay card may be used up to 4 times per calendar year.

What happens if I change pharmacies?

Present your Co-pay Savings Card with a valid prescription for ARISTADA INITIO/ARISTADA at the new pharmacy. If your prescription was called into the pharmacy by your doctor, simply present your Co-pay Savings Card to the pharmacist.

Am I eligible for the ARISTADA Co-pay Savings Card?

This Program is only available to commercially insured patients who are 18 years or older with a valid ARISTADA INITIO and/or ARISTADA prescription(s) This Program is not available to patients who are enrolled in, or covered by, any local, state, federal or other government program that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program Patients who become eligible for any government program that pays for any portion of medication costs will no longer be eligible for this Program This Program is not valid for cash paying patients Patients must live in the United States or Puerto Rico Patients must meet the Program requirements every time they use the ARISTADA INITIO and/or ARISTADA Co-pay Savings Card (“Co-pay Card”)

Can I be reimbursed for the Co-pay Savings Card if I already paid my co-pay?

The ARISTADA Co-Pay Savings Program can be applied to eligible prescriptions filled within a 90-day period prior to enrollment in the Program, as long as you were qualified for the program at the time the prescriptions were filled. Once you have confirmed eligibility and activate the Co-Pay Savings Program Card, you will need to call the pharmacy and ask the pharmacy to apply the ARISTADA Co-Pay Savings Program benefit to your previous claims and credit your account. If the pharmacy is unable to apply the program benefit to previous claims and credit your account, you can complete the Direct Member Reimbursement Form at www.patientrebateonline.com

Can I use my Co-pay Savings Card if I do not have insurance or if my insurance does not cover ARISTADA INITIO or ARISTADA?

No, the ARISTADA Co-pay Savings Card is only approved for patients with commercial insurance. If you would like to learn more about other forms of assistance from Alkermes, please call ARISTADA Care Support at 1-866-ARISTADA or 1-866-274-7823 (9:00 AM-8:00 PM ET, Monday-Friday). You cannot use the Co-pay Savings Card if you become eligible for any local, state, federal, or other government program that pays for any portion of the medication costs including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program. You are not eligible for the Co-pay Savings Card if you are paying for your ARISTADA INITIO and/or ARISTADA prescription with cash.

Can I use the Co-pay Savings Card when I pick up my loved one’s prescription?

Yes, present their Co-pay Savings Card to the pharmacist along with their primary insurance information. If the pharmacist has any questions about using the card, they should call the LoyaltyScript® program for the ARISTADA Co-pay Savings Program at 1-800-657-7613 (8:00 AM-8:00 PM ET, Monday-Friday).

Can I use my card with a mail-order provider?

There are several prescription mail-order service providers available. We have processed transactions from many of them. To determine if your mail-order provider will accept an ARISTADA INITIO or ARISTADA Co-pay Savings Card, we recommend that you call them and ask. In order to process the transaction, they will need the numbers on the front of the card, so have the card ready when you call.

Do I need a new prescription to use the Co-pay Savings Card, or can I use it for my existing prescription?

No, it is not necessary to obtain a new prescription to use the card as long as you have a valid prescription for ARISTADA INITIO/ARISTADA.

Is there a charge to use the card?

No, there is no charge to use the card. The benefit is provided to you by Alkermes, Inc. You will need to pay the balance of your co-pay.

ARISTADA® (aripiprazole lauroxil)

IMPORTANT SAFETY INFORMATION AND INDICATION

Aristada ISI

Indication Section

INDICATION

ARISTADA INITIO (aripiprazole lauroxil) is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start ARISTADA (aripiprazole lauroxil) treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the treatment of schizophrenia in adults.

ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia in adults.

It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in children under 18 years of age.

Boxed Warning

IMPORTANT SAFETY INFORMATION

Elderly people with dementia-related psychosis are at increased risk of death when treated with antipsychotic medicines including ARISTADA INITIO and ARISTADA. ARISTADA INITIO and ARISTADA are not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).

ISI Copy

Contraindication: Do not receive ARISTADA INITIO or ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA. Allergic reactions to aripiprazole have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

ARISTADA INITIO and/or ARISTADA may cause serious side effects including:

Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure

Uncontrolled body movements (tardive dyskinesia). ARISTADA INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
Problems with your metabolism such as:
- High blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who receive ARISTADA INITIO and/or ARISTADA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA.
  - Call your healthcare provider if you have any of these symptoms of high blood sugar:
    - feel very thirsty
    - need to urinate more than usual
    - feel very hungry
    - feel weak or tired
    - feel sick to your stomach
    - feel confused, or your breath smells fruity
- Increased fat levels (cholesterol and triglycerides) in your blood
- Weight gain. You and your healthcare provider should check your weight regularly.
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy when standing which may make you at risk for falls and related injuries.
Low white blood cell count
Seizures (convulsions)
Problems controlling your body temperature. Avoid becoming too hot or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
Difficulty swallowing

The most common side effects of ARISTADA INITIO and ARISTADA include restlessness or feeling like you need to move (akathisia). These are not all the possible side effects of ARISTADA INITIO and ARISTADA. You should tell your healthcare provider about any side-effects you have.

Do not drive, operate hazardous machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA INITIO and ARISTADA may affect your judgment, thinking or motor skills.

Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider about all of your medical conditions, including if you:

have not 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 receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA
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 INITIO and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or 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 INITIO and/or ARISTADA can pass into your breast milk. 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 INITIO and/or ARISTADA.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ARISTADA INITIO and ARISTADA and other medicines may affect each other causing possible serious side effects. Do not start or stop any medicines after you receive ARISTADA INITIO and ARISTADA without talking to your healthcare provider first.

If you have any questions about your health or medicines, talk to your healthcare provider. You are encouraged to report all side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Prescription Information

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

Aristada ISI

Boxed Warning

IMPORTANT SAFETY INFORMATION

ISI Copy

ARISTADA INITIO and/or ARISTADA may cause serious side effects including:

Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure

Uncontrolled body movements (tardive dyskinesia). ARISTADA INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
Problems with your metabolism such as:
- High blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who receive ARISTADA INITIO and/or ARISTADA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA.
  - Call your healthcare provider if you have any of these symptoms of high blood sugar:
    - feel very thirsty
    - need to urinate more than usual
    - feel very hungry
    - feel weak or tired
    - feel sick to your stomach
    - feel confused, or your breath smells fruity
- Increased fat levels (cholesterol and triglycerides) in your blood
- Weight gain. You and your healthcare provider should check your weight regularly.
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy when standing which may make you at risk for falls and related injuries.
Low white blood cell count
Seizures (convulsions)
Problems controlling your body temperature. Avoid becoming too hot or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
Difficulty swallowing

Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider about all of your medical conditions, including if you:

have not 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 receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA
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 INITIO and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or 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 INITIO and/or ARISTADA can pass into your breast milk. 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 INITIO and/or ARISTADA.

Prescription Information

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

Indication Section

INDICATION

ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia in adults.

It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in children under 18 years of age.

IMPORTANT SAFETY INFORMATION AND INDICATION

Aristada ISI

Indication Section

INDICATION

ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia in adults.

It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in children under 18 years of age.

Boxed Warning

IMPORTANT SAFETY INFORMATION

ISI Copy

ARISTADA INITIO and/or ARISTADA may cause serious side effects including:

Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure

Uncontrolled body movements (tardive dyskinesia). ARISTADA INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
Problems with your metabolism such as:
- High blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who receive ARISTADA INITIO and/or ARISTADA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA.
  - Call your healthcare provider if you have any of these symptoms of high blood sugar:
    - feel very thirsty
    - need to urinate more than usual
    - feel very hungry
    - feel weak or tired
    - feel sick to your stomach
    - feel confused, or your breath smells fruity
- Increased fat levels (cholesterol and triglycerides) in your blood
- Weight gain. You and your healthcare provider should check your weight regularly.
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy when standing which may make you at risk for falls and related injuries.
Low white blood cell count
Seizures (convulsions)
Problems controlling your body temperature. Avoid becoming too hot or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
Difficulty swallowing

Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider about all of your medical conditions, including if you:

have not 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 receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA
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 INITIO and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or 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 INITIO and/or ARISTADA can pass into your breast milk. 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 INITIO and/or ARISTADA.

Prescription Information

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

Aristada ISI

Boxed Warning

IMPORTANT SAFETY INFORMATION

ISI Copy

ARISTADA INITIO and/or ARISTADA may cause serious side effects including:

Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death.
Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
- high fever
- stiff muscles
- confusion
- sweating
- changes in pulse, heart rate, and blood pressure

Uncontrolled body movements (tardive dyskinesia). ARISTADA INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ARISTADA. Tardive dyskinesia may also start after you stop receiving ARISTADA.
Problems with your metabolism such as:
- High blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who receive ARISTADA INITIO and/or ARISTADA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA.
  - Call your healthcare provider if you have any of these symptoms of high blood sugar:
    - feel very thirsty
    - need to urinate more than usual
    - feel very hungry
    - feel weak or tired
    - feel sick to your stomach
    - feel confused, or your breath smells fruity
- Increased fat levels (cholesterol and triglycerides) in your blood
- Weight gain. You and your healthcare provider should check your weight regularly.
Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had strong unusual urges such as gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.
Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy when standing which may make you at risk for falls and related injuries.
Low white blood cell count
Seizures (convulsions)
Problems controlling your body temperature. Avoid becoming too hot or dehydrated. Do not exercise too much. In hot weather, stay inside in a cool place if possible. Stay out of the sun. Do not wear too much clothing or heavy clothing. Drink plenty of water.
Difficulty swallowing

Before receiving ARISTADA INITIO and ARISTADA tell your healthcare provider about all of your medical conditions, including if you:

have not 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 receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA
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 INITIO and/or ARISTADA will harm your unborn baby. If you become pregnant while taking ARISTADA INITIO and/or 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 INITIO and/or ARISTADA can pass into your breast milk. 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 INITIO and/or ARISTADA.

Prescription Information

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

Indication Section

INDICATION

ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia in adults.

It is not known if ARISTADA INITIO and/or ARISTADA are safe and effective in children under 18 years of age.

REsOURCEs are available

Support services for you and your loved ones:

For more information, talk with your healthcare provider. To speak with an ARISTADA Care Support representative, call 1-866-ARISTADA (1-866-274-7823), Monday through Friday, 9 AM to 8 PM ET.

Looking for a healthcare provider in your area?

If you have any questions about the Provider Network, call 1-866-ARISTADA (1-866-274-7823), Monday through Friday, 9 AM to 8 PM ET.

The ARISTADA Co-pay Savings Program

Sign Up

Frequently Asked Questions about the Co-pay Savings Program

How much will I save?

What happens if I change pharmacies?

Am I eligible for the ARISTADA Co-pay Savings Card?

Can I be reimbursed for the Co-pay Savings Card if I already paid my co-pay?

Can I use my Co-pay Savings Card if I do not have insurance or if my insurance does not cover ARISTADA INITIO or ARISTADA?

Can I use the Co-pay Savings Card when I pick up my loved one’s prescription?

Can I use my card with a mail-order provider?

Do I need a new prescription to use the Co-pay Savings Card, or can I use it for my existing prescription?

Is there a charge to use the card?

Get resources to help you on your treatment journey

Discover videos and real stories

Explore downloadable resources

ARISTADA Patient Brochure

ARISTADA Caregiver Brochure

Journal & Coloring Book

ARISTADA Doctor Discussion Guide

Create your personalized Doctor Discussion Guide

There are many organizations that may be able to help

There are many groups that can provide you with support

American Psychiatric Association

Mental Health America

National Alliance on Mental Illness

National Institute of Mental Health

Schizophrenia & Psychosis Action Alliance

Substance Abuse and Mental Health Services Administration

Suicide & Crisis Lifeline

ARISTADA Frequently Asked Questions

What is the most important information I should know about ARISTADA INITIO and ARISTADA?

What is ARISTADA INITIO?

What is ARISTADA?

Who should not receive ARISTADA INITIO and ARISTADA?

What should I tell my doctor before receiving ARISTADA INITIO and ARISTADA?

Should I tell my doctor about other medicines I take?

How will I receive ARISTADA INITIO?

How should I receive ARISTADA?

What should I avoid while receiving ARISTADA INITIO and ARISTADA?

What are the possible side effects of ARISTADA INITIO and ARISTADA?

What are the ingredients in ARISTADA INITIO?

What are the ingredients in ARISTADA?

General information about the safe and effective use of ARISTADA INITIO and ARISTADA

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATION

Aristada ISI

INDICATION

IMPORTANT SAFETY INFORMATION

Aristada ISI

IMPORTANT SAFETY INFORMATION

INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATION

IMPORTANT SAFETY INFORMATION AND INDICATION

Aristada ISI

INDICATION

IMPORTANT SAFETY INFORMATION

Aristada ISI

IMPORTANT SAFETY INFORMATION

INDICATION

REsOURCEs
are available

For more information, talk with your healthcare provider. To speak with an ARISTADA Care Support representative, call 1-866-ARISTADA  (1-866-274-7823), Monday through Friday, 9 AM to 8 PM ET.

If you have any questions about the Provider Network, 
call 1-866-ARISTADA (1-866-274-7823), Monday through Friday, 9 AM to 8 PM ET.

ARISTADA Patient
Brochure

ARISTADA Caregiver
Brochure

Journal & Coloring
Book

American Psychiatric Association 

National Alliance on Mental Illness 

National Institute of Mental Health 

Schizophrenia & Psychosis Action Alliance 

Substance Abuse and Mental Health Services Administration 

Suicide & Crisis Lifeline 