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Questions & Answers

Get answers about REXULTI® (brexpiprazole) by clicking
on the questions below.

Taking REXULTI

How should I take REXULTI?

REXULTI is taken once daily, and you can take it with or without food.

It’s important that you follow the dosing schedule prescribed by your healthcare provider. Here are a few tips that may help you stay on schedule:

  • Make taking your medication part of your daily routine
  • Get a daily reminder from a family member or friend
  • Keep your REXULTI pills in order with a weekly pillbox

Take REXULTI as your healthcare provider prescribed it.

  • Your healthcare provider may change your dose if needed. Do not change the dose or stop taking REXULTI without first talking to your healthcare provider.
  • Take REXULTI 1 time each day with or without food.
  • Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI.

If you take too much REXULTI, call your healthcare provider or the Poison Control Center at 1-800-222-1222 right away or go to the nearest hospital emergency room.

When will REXULTI start working for me?

Not everyone responds to medication the same way, and your body may need time to adapt. That's why it is important to share how you are feeling with your healthcare provider, including any side effects. This way, he or she will better understand what effect your treatment may be having and adjust if necessary. Write down questions you have about your treatment and share them with your healthcare provider. Always talk to your doctor before making any changes to your treatment.

What should I tell my healthcare provider before taking REXULTI?

Before taking REXULTI, tell your healthcare provider about all of your medical conditions, including if you:

  • have or have had heart problems or a stroke
  • have or have had low or high blood pressure
  • have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
  • have of have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
  • have or have had seizures (convulsions)
  • have or have had kidney or liver problems
  • have or have had a low white blood cell count
  • are pregnant or plan to become pregnant. REXULTI may harm your unborn baby. Taking REXULTI during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take REXULTI during pregnancy.
    • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with REXULTI.

    • There is a pregnancy exposure registry for women who are exposed to REXULTI during pregnancy. If you become pregnant during treatment with REXULTI, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. 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. It is not known if REXULTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REXULTI.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

REXULTI and other medicines may affect each other causing possible serious side effects. REXULTI may affect the way other medicines work, and other medicines may affect how REXULTI works.

Your healthcare provider can tell you if it is safe to take REXULTI with your other medicines. Do not start or stop any medicines during treatment with REXULTI without first talking to your healthcare provider.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Possible side effects

Take note of any side effects you or your loved one experiences while on REXULTI, and report them to your healthcare provider, especially if they are new, worse, or worry you.

What are the possible side effects of REXULTI?

Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI.

Serious side effects may happen when you take REXULTI, including:

  • Increased risk of death in elderly people with dementia-related psychosis. REXULTI is not approved for the treatment of patients with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer’s disease.
  • Increased risk of suicidal thoughts and actions. Antidepressant medicines may increase suicidal thoughts and actions in pediatric patients and young adult patients, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.
  • Cerebrovascular problems, including stroke, in elderly people with dementia-related psychosis that can lead to death.
  • Neuroleptic malignant syndrome (NMS) is 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; changes in your pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; increased sweating
  • Uncontrolled body movements (tardive dyskinesia). REXULTI may cause movements that you cannot control in your face, tongue or other body parts, which may not go away.
  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take REXULTI, and extremely high blood sugar can lead to coma or death.
  • Increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start REXULTI, and then periodically during treatment with REXULTI.
  • Weight gain. You and your healthcare provider should check your weight before you start and often during treatment with REXULTI.
  • Unusual and uncontrollable (compulsive) urges. Some people taking REXULTI have had strong unusual urges, to gamble and 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 new or unusual strong urges or behaviors, talk to your healthcare provider.
  • Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with REXULTI.
  • Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded or pass out (faint) when you rise too quickly from a sitting or lying position.
  • Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
  • Seizures (convulsions)
  • Problems controlling your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with REXULTI.
  • Difficulty swallowing. This may cause food or liquid to get into your lungs.
  • Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy.

The most common side effects of Rexulti include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia).

These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about your health or medicines, including side effects.

Could REXULTI affect my blood sugar?

An increase in blood sugar (hyperglycemia) can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death.

Call your healthcare provider if you have any of these symptoms of high blood sugar while taking REXULTI: You feel very thirsty; feel very hungry; feel sick to your stomach; need to urinate more than usual; feel weak or tired; feel confused, or your breath smells fruity.

Could REXULTI affect my cholesterol?

An increase in the fat levels (cholesterol and triglycerides) in your blood may occur while taking REXULTI. Before starting on REXULTI, discuss with your healthcare provider if you have high levels of cholesterol, triglycerides, LDL-cholesterol, or low levels of HDL cholesterol.

Your healthcare provider should check the fat levels in your blood before you start, or soon after you start REXULTI, and then periodically during treatment with REXULTI.

During clinical trials,* changes in fasting total cholesterol, LDL-cholesterol, and HDL cholesterol were similar between adult patients taking REXULTI and adult patients taking a placebo (a pill with no medicine in it).

Will REXULTI make me gain weight?

Weight gain has been reported in people taking medicines like REXULTI, so you and your healthcare provider should check your weight before you start and often during treatment with REXULTI.

In two 6-week clinical trials* of adults with schizophrenia, 4% of patients taking REXULTI reported an increase in body weight, compared with 2% of patients taking a placebo (a pill with no medicine in it).

In these same trials, no patients stopped using REXULTI due to weight gain.

Will REXULTI make me feel restless?

During clinical trials,* 6% of adult patients taking REXULTI reported feelings of restlessness (akathisia), such as feeling like you need to move, compared to 5% of patients taking a placebo (a pill with no medicine in it).

Will REXULTI make me feel sleepy or tired?

In clinical trials,* less than 5% of adult patients taking REXULTI experienced drowsiness compared to 3% of adult patients taking a placebo (a pill with no medicine in it).

Until you know how REXULTI affects you, do not drive, operate heavy machinery, or do other dangerous activities.

*Researchers studied REXULTI in clinical trials

REXULTI was studied in two 6-week clinical trials of 852 adult patients aged 18-65 who had been diagnosed with schizophrenia. Some of the patients were randomly selected to receive either 2 mg or 4 mg/day of REXULTI, while the rest received a placebo (a pill with no medicine in it). At the end of 6 weeks, some patients who took REXULTI saw a reduction in their symptoms of schizophrenia.

Start the conversation with
your doctor about REXULTI

Get the Doctor Discussion Guide

Are you caring for a loved
one with schizophrenia?

Get helpful tips and resources

Are you taking an antidepressant but still experiencing depression symptoms?

Think about how depression may still be affecting you.

Select the most appropriate response for each of the following statements. When finished, click 'Create My Discussion Guide' to receive a PDF of your responses along with the Doctor Discussion Guide to discuss with your healthcare provider. Please note that all answer fields must be completed. Your answers are completely confidential and will not be stored or shared.

(Select the closest answer)

Over the last 2 weeks, how often have you been bothered by any of the following problems?

1.Little interest or pleasure in doing things
2.Feeling down, depressed, or hopeless
3.Trouble falling or staying asleep, or sleeping too much
4.Feeling tired or having little energy
5.Poor appetite or overeating
6.Feeling bad about yourself—or that you are a failure or have let yourself or your family down
7.Trouble concentrating on things, such as reading the newspaper or watching television
8.Moving or speaking so slowly that other people could have noticed. Or the opposite—being so fidgety or restless that you have been moving around a lot more than usual
9.Thoughts that you would be better off dead, or of hurting yourself in some way
10.If you checked off any problems, how difficult have these problems made it for you to do your work, take care of things at home, or get along with other people?

Download and print My Discussion Guide to help start the conversation with your doctor.

Please complete all questions.

Adapted from the PHQ-9 scale developed by Drs. Robert L. Spitzer, Janet B.W. Williams, Kurt Kroenke and colleagues, with an educational grant from Pfizer Inc.

This resource is provided for informational purposes only and is not intended as a substitute for a healthcare professional’s independent judgment. Always follow the healthcare advice of your doctor.
Do not change the way you take your medication without talking with your doctor.

If you ever have suicidal thoughts, call your doctor or 911, or go to an emergency room. Take suicidal thoughts seriously and get help immediately.

Close

INDICATION and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)

INDICATION:
REXULTI is a prescription medicine used to treat schizophrenia in adults and children ages 13 years and older.

It is not known if REXULTI is safe and effective in children under 13 years of age with schizophrenia.

IMPORTANT SAFETY INFORMATION:
  • Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer’s disease.
  • Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase suicidal thoughts and actions in pediatric patients and young adult patients, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. All patients on antidepressants and their families or caregivers should closely watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. Report any change in these symptoms immediately to the doctor.

Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI.

REXULTI 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) is 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; changes in your pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; increased sweating
  • Uncontrolled body movements (tardive dyskinesia). REXULTI 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 taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI.

  • Problems with your metabolism such as:
    • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start REXULTI and then regularly during long term treatment with REXULTI.

      Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with REXULTI:
      • feel very thirsty
      • feel very hungry
      • feel sick to your stomach
      • need to urinate more than usual
      • feel weak or tired
      • feel confused, or your breath smells fruity
    • increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start REXULTI, and then periodically during treatment with REXULTI.
    • weight gain. You and your healthcare provider should check your weight before you start and often during treatment with REXULTI.
  • Unusual and uncontrollable (compulsive) urges. Some people taking REXULTI have had strong unusual urges, to gamble and 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 new or unusual strong urges or behaviors, talk to your healthcare provider.

  • Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with REXULTI.
  • Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded or pass out (faint) when you rise too quickly from a sitting or lying position.
  • Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
  • Seizures (convulsions).
  • Problems controlling your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with REXULTI. 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 that can cause food or liquid to get into your lungs.
  • Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy.
Before taking REXULTI, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had heart problems or a stroke
  • have or have had low or high blood pressure
  • have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
  • have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
  • have or have had seizures (convulsions)
  • have or have had kidney or liver problems
  • have or have had a low white blood cell count
  • are pregnant or plan to become pregnant. REXULTI may harm your unborn baby. Taking REXULTI during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take REXULTI during pregnancy.
    • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with REXULTI.
    • There is a pregnancy exposure registry for women who are exposed to REXULTI during pregnancy. If you become pregnant during treatment with REXULTI, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. 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. It is not known if REXULTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REXULTI.

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

The most common side effects of REXULTI include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia).

These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report side effects of REXULTI (brexpiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438‑9927 or FDA at 1‑800‑FDA‑1088 (www.fda.gov/medwatch).

 

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

IMPORTANT SAFETY INFORMATION and INDICATION for
REXULTI® (brexpiprazole)
See More
Minimize
IMPORTANT SAFETY INFORMATION:
  • Increased risk of death in elderly people with dementia-related psychosis. Medicines like REXULTI can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of people with dementia-related psychosis without agitation that may happen with dementia due to Alzheimer’s disease.
  • Increased risk of suicidal thoughts and actions. REXULTI and antidepressant medicines may increase suicidal thoughts and actions in pediatric patients and young adult patients, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions. All patients on antidepressants and their families or caregivers should closely watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. Report any change in these symptoms immediately to the doctor.

Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI.

REXULTI 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) is 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; changes in your pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; increased sweating
  • Uncontrolled body movements (tardive dyskinesia). REXULTI 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 taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI.

  • Problems with your metabolism such as:
    • high blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. Your healthcare provider should check your blood sugar before you start, or soon after you start REXULTI and then regularly during long term treatment with REXULTI.

      Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with REXULTI:
      • feel very thirsty
      • feel very hungry
      • feel sick to your stomach
      • need to urinate more than usual
      • feel weak or tired
      • feel confused, or your breath smells fruity
    • increased fat levels (cholesterol and triglycerides) in your blood. Your healthcare provider should check the fat levels in your blood before you start, or soon after you start REXULTI, and then periodically during treatment with REXULTI.
    • weight gain. You and your healthcare provider should check your weight before you start and often during treatment with REXULTI.
  • Unusual and uncontrollable (compulsive) urges. Some people taking REXULTI have had strong unusual urges, to gamble and 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 new or unusual strong urges or behaviors, talk to your healthcare provider.

  • Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with REXULTI.
  • Decreased blood pressure (orthostatic hypotension) and fainting. You may feel dizzy, lightheaded or pass out (faint) when you rise too quickly from a sitting or lying position.
  • Falls. REXULTI may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position (orthostatic hypotension), and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
  • Seizures (convulsions).
  • Problems controlling your body temperature so that you feel too warm. Do not become too hot or dehydrated during treatment with REXULTI. 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 that can cause food or liquid to get into your lungs.
  • Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Do not drive a car, operate machinery, or do other dangerous activities until you know how REXULTI affects you. REXULTI may make you feel drowsy.
Before taking REXULTI, tell your healthcare provider about all of your medical conditions, including if you:
  • have or have had heart problems or a stroke
  • have or have had low or high blood pressure
  • have or have had diabetes or high blood sugar or a family history of diabetes or high blood sugar.
  • have or have had high levels of total cholesterol, LDL cholesterol, or triglycerides, or low levels of HDL cholesterol
  • have or have had seizures (convulsions)
  • have or have had kidney or liver problems
  • have or have had a low white blood cell count
  • are pregnant or plan to become pregnant. REXULTI may harm your unborn baby. Taking REXULTI during your third trimester of pregnancy may cause your baby to have abnormal muscle movements or withdrawal symptoms after birth. Talk to your healthcare provider about the risk to your unborn baby if you take REXULTI during pregnancy.
    • Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with REXULTI.
    • There is a pregnancy exposure registry for women who are exposed to REXULTI during pregnancy. If you become pregnant during treatment with REXULTI, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychiatric Medications. 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. It is not known if REXULTI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with REXULTI.

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

The most common side effects of REXULTI include weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia).

These are not all the possible side effects of REXULTI. For more information, ask your healthcare provider or pharmacist.

You are encouraged to report side effects of REXULTI (brexpiprazole). Please contact Otsuka America Pharmaceutical, Inc. at 1‑800‑438‑9927 or FDA at 1‑800‑FDA‑1088 (www.fda.gov/medwatch).

 
INDICATION:
REXULTI is a prescription medicine used to treat schizophrenia in adults and children ages 13 years and older.

It is not known if REXULTI is safe and effective in children under 13 years of age with schizophrenia.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING, and MEDICATION GUIDE.

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