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Why REXULTI® (brexpiprazole)?

You may have made some progress. Why stop there?

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REXULTI works with the antidepressant you’re already taking.

You shouldn’t have to give up on the progress you may have made with your current antidepressant.

REXULTI is for people who’ve been on an antidepressant for at least 8 weeks and are still experiencing symptoms of depression. When taken with your antidepressant, REXULTI may help you feel better by reducing symptoms of depression. Ask your doctor if REXULTI is right for you.

Still struggling with symptoms of depression?

Get questions to ask your doctor

Tell your healthcare provider about all the medicines you take or recently have taken, including prescription medicines, 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 while taking REXULTI without talking to your healthcare provider first.

When will REXULTI start working for me?

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. Write down questions you have about your treatment and share them with your doctor. Always talk to your doctor before making any changes to your treatment.

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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.

Clinical trial results

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.

Contraindication: Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. Allergic reactions have included rash, facial swelling, hives and itching, and anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

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INDICATION AND IMPORTANT SAFETY INFORMATION for REXULTI® (brexpiprazole)

INDICATION: REXULTI is a prescription medicine used to treat:
  • Major depressive disorder (MDD): REXULTI is used with antidepressant medicines, when your healthcare provider determines that an antidepressant alone is not enough to treat your depression.

It is not known if REXULTI is safe and effective in people under 18 years of age.

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 who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of patients with dementia-related psychosis.

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms immediately to the doctor. REXULTI is not approved for the treatment of people younger than 18 years of age.

Contraindication: Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. Allergic reactions have included rash, facial swelling, hives and itching, and anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

REXULTI may cause serious side effects, including:
  • Stroke in elderly people (cerebrovascular problems) that can lead to death.
  • Neuroleptic Malignant Syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
  • 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): Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or having a family history of diabetes), your healthcare provider should check your blood sugar before you start taking REXULTI and during your treatment.

      Call your healthcare provider if you have any of these symptoms of high blood sugar while taking REXULTI:
      • feel very thirsty
      • feel very hungry
      • feel sick to your stomach
      • feel weak or tired
      • need to urinate more than usual
      • 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.
  • Low white blood cell count
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Seizures (convulsions)
  • Problems controlling your body temperature so that you feel too warm. Avoid getting over-heated or dehydrated while taking REXULTI.
    • Do not over-exercise.
    • Stay out of the sun. Do not wear too
      much or heavy clothing.
    • In hot weather, stay inside in a cool
      place if possible.
    • Drink plenty of water.
  • Difficulty swallowing that can cause food or liquid to get into your lungs.

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.

Avoid drinking alcohol while taking REXULTI.

Before taking REXULTI, tell your healthcare provider if you:
  • 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 REXULTI and during your treatment.
  • have high levels of cholesterol, triglycerides, LDL cholesterol, or low levels of HDL cholesterol
  • have or had seizures (convulsions)
  • have or had low or high blood pressure
  • have or had heart problems or a stroke
  • have or had a low white blood cell count
  • are pregnant or plan to become pregnant. It is not known if REXULTI may harm your unborn baby. Using REXULTI in the last trimester of pregnancy may cause muscle movement problems, medicine withdrawal symptoms, or both of these in your newborn.
  • are breastfeeding or plan to breastfeed. It is not known if REXULTI passes into your breast milk. You and your healthcare provider should decide if you will take REXULTI or breastfeed.

Tell your healthcare provider about all the medicines you take or recently have taken, including prescription medicines, 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 while taking REXULTI without talking to your healthcare provider first.

The most common side effects of REXULTI include weight gain and an inner sense of restlessness such as feeling like you need to move.

Tell your healthcare provider if you experience abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia.

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.

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 U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING, and Medication Guide for REXULTI.

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IMPORTANT SAFETY INFORMATION AND INDICATION for
REXULTI® (brexpiprazole)
See More
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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 who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). REXULTI is not approved for the treatment of patients with dementia-related psychosis.

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any changes in these symptoms immediately to the doctor. REXULTI is not approved for the treatment of people younger than 18 years of age.

Contraindication: Do not take REXULTI if you are allergic to brexpiprazole or any of the ingredients in REXULTI. Allergic reactions have included rash, facial swelling, hives and itching, and anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

REXULTI may cause serious side effects, including:
  • Stroke in elderly people (cerebrovascular problems) that can lead to death.
  • Neuroleptic Malignant Syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
  • 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): Increases in blood sugar can happen in some people who take REXULTI. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or having a family history of diabetes), your healthcare provider should check your blood sugar before you start taking REXULTI and during your treatment.

      Call your healthcare provider if you have any of these symptoms of high blood sugar while taking REXULTI:
      • feel very thirsty
      • feel very hungry
      • feel sick to your stomach
      • feel weak or tired
      • need to urinate more than usual
      • 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.
  • Low white blood cell count
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Seizures (convulsions)
  • Problems controlling your body temperature so that you feel too warm. Avoid getting over-heated or dehydrated while taking REXULTI.
    • Do not over-exercise.
    • Stay out of the sun. Do not wear too
      much or heavy clothing.
    • In hot weather, stay inside in a cool
      place if possible.
    • Drink plenty of water.
  • Difficulty swallowing that can cause food or liquid to get into your lungs.

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.

Avoid drinking alcohol while taking REXULTI.

Before taking REXULTI, tell your healthcare provider if you:
  • 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 REXULTI and during your treatment.
  • have high levels of cholesterol, triglycerides, LDL cholesterol, or low levels of HDL cholesterol
  • have or had seizures (convulsions)
  • have or had low or high blood pressure
  • have or had heart problems or a stroke
  • have or had a low white blood cell count
  • are pregnant or plan to become pregnant. It is not known if REXULTI may harm your unborn baby. Using REXULTI in the last trimester of pregnancy may cause muscle movement problems, medicine withdrawal symptoms, or both of these in your newborn.
  • are breastfeeding or plan to breastfeed. It is not known if REXULTI passes into your breast milk. You and your healthcare provider should decide if you will take REXULTI or breastfeed.

Tell your healthcare provider about all the medicines you take or recently have taken, including prescription medicines, 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 while taking REXULTI without talking to your healthcare provider first.

The most common side effects of REXULTI include weight gain and an inner sense of restlessness such as feeling like you need to move.

Tell your healthcare provider if you experience abnormal muscle spasms or contractions, which may be a sign of a condition called dystonia.

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.

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 U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNING, and Medication Guide for REXULTI.

INDICATION: REXULTI is a prescription medicine used to treat:
  • Major depressive disorder (MDD): REXULTI is used with antidepressant medicines, when your healthcare provider determines that an antidepressant alone is not enough to treat your depression.

It is not known if REXULTI is safe and effective in people under 18 years of age.

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January 2017        11US16EBC008211US16EBC008111US16EBC0080

How were your symptoms of depression this week?

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 )

During the past week, including today...

1. I felt sad or depressed.
2. I was not as interested in my usual activities.
3. My appetite was poor, and I didn’t feel like eating.
4. My appetite was much greater than usual.
5. I had difficulty sleeping.
6. I was sleeping too much.
7. I felt very fidgety, making it difficult to sit still.
8. I felt physically slowed down, like my body was stuck in mud.
9. My energy level was low.
10. I felt guilty.
11. I thought I was a failure.
12. I had problems concentrating.
13. I had more difficulties making decisions than usual.
14. I wished I was dead.
15. I thought about killing myself.
16. I thought that the future looked hopeless.
17. Overall, how much have symptoms of depression interfered with or caused difficulties in your life during the past week?
18. How would you rate your overall quality of life during the past week?

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

Create My Discussion Guide

Adapted from the Clinically Useful Depression Outcome Scale (CUDOS), developed by Mark Zimmerman, MD, Director of Outpatient Psychiatry at Rhode Island Hospital. Compr Psychiatry. Mar-Apr 2008;49(2):131-140.

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.

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