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    REXULTI?
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Proven to reduce the symptoms of depression

Female REXULTI user celebrating her dog's birthday alongside family with smiley face sign stuffed in bag.
Actor Portrayals

REXULTI works with your antidepressant to help build on the progress you've already made.

6-week study in adults, with ongoing symptoms of depression,
still taking an antidepressant. Individual results may vary.

When taken with an antidepressant,* REXULTI was proven to significantly reduce depression symptoms more than the antidepressant alone. So you may feel better—without feeling like you have to start over.

*REXULTI is for people who have been on an antidepressant for at least 2 months and are still experiencing symptoms of depression.

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Is REXULTI right for you?

REXULTI may help if you've been on an antidepressant for at least 2 months and are still experiencing depression symptoms. The first step is to talk to your doctor.

READY TO TALK TO YOUR DOCTOR?

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

What the studies show

REXULTI was studied in two 6-week clinical trials of 1,054 patients aged 18-65 diagnosed with major depressive disorder (MDD). The patients selected for the studies took an antidepressant for at least 8 weeks. Patients who then had ongoing symptoms of depression were randomly selected to receive 1 mg to 3 mg/day of REXULTI in addition to their antidepressant, while the rest continued taking their antidepressant alone.

At the end of 6 weeks, some patients who added REXULTI to their current antidepressant experienced a greater improvement in their symptoms of depression than the patients who continued taking only their antidepressant.

Side effects of REXULTI

The most common side effects associated with REXULTI plus an antidepressant were weight gain and an inner sense of restlessness, such as feeling like you need to move (akathisia), as reported during 6-week clinical studies of adults with major depressive disorder (MDD).

You and your healthcare provider should check your weight regularly. In 6-week clinical studies of adults with MDD, 7% of patients taking REXULTI plus an antidepressant reported an increase in body weight, compared with 2% of patients taking an antidepressant plus a placebo (nontherapeutic pill).

In the same studies, akathisia was reported by 9% of patients taking REXULTI plus an antidepressant and by 2% of patients taking an antidepressant plus a placebo.

See additional side effect information for REXULTI

From the My Path Forward Video Series:

Is there more I can do for my depression? (Episode 2)

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How REXULTI is thought to work

Brain science icon

The science of depression

In the brain, certain chemicals called “neurotransmitters” carry signals from one neuron (or nerve cell) to another. Neurotransmitters interact with specialized proteins on nerve cells. These proteins are called “receptors.” It’s believed that an imbalance of neurotransmitters may contribute to the symptoms of depression.

Designed with purpose

While the exact way REXULTI works is unknown, scientists believe that it has a similar range of activity at 3 types of neurotransmitter receptors: serotonin, dopamine, and norepinephrine. REXULTI was specifically designed to have similar activity at 2 of these receptors: serotonin and dopamine.

After years of research and testing, REXULTI was approved for use in the United States by the Food and Drug Administration (FDA) in 2015.

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How fast does it work?

Not everyone responds to medication the same way, and your body may need time to adapt. Therefore, 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.

Ready to talk to your doctor?

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How to take REXULTI

  • Take REXULTI exactly as your healthcare provider tells you to take 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 once daily 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.
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Talk to your doctor

Talking to your doctor is the first step to learning if REXULTI is right for you.

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REXULTI® (brexpiprazole) savings card

Paying for REXULTI

If you are commercially insured, you may be eligible for the REXULTI Savings Card.†

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†This program is not health insurance. Further conditions apply.

INDICATION and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)

INDICATIONS and IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)

INDICATIONS: 

REXULTI is a prescription medicine used:

  • along with antidepressant medicines to treat major depressive disorder (MDD) in adults
  • to treat schizophrenia in adults and children ages 13 years and older
  • to treat agitation that may happen with dementia due to Alzheimer’s disease

REXULTI should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

It is not known if REXULTI is safe and effective in children with MDD.

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

INDICATION: 

REXULTI is a prescription medicine used along with antidepressant medicines to treat major depressive disorder (MDD) in adults.

It is not known if REXULTI is safe and effective in children with MDD.

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.

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This website is intended for use by U.S. residents. May 2024  11US24EBC0078
IMPORTANT SAFETY INFORMATION AND INDICATION for
REXULTI® (brexpiprazole)
IMPORTANT SAFETY INFORMATION AND INDICATIONS for
REXULTI® (brexpiprazole)
 
 

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 along with antidepressant medicines to treat major depressive disorder (MDD) in adults.

It is not known if REXULTI is safe and effective in children with MDD.

INDICATIONS: 

REXULTI is a prescription medicine used:

  • along with antidepressant medicines to treat major depressive disorder (MDD) in adults
  • to treat schizophrenia in adults and children ages 13 years and older
  • to treat agitation that may happen with dementia due to Alzheimer’s disease

REXULTI should not be used as an “as needed” treatment for agitation that may happen with dementia due to Alzheimer’s disease.

It is not known if REXULTI is safe and effective in children with MDD.

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.

 

 

 

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