Questions & Answers

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

It’s important to 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
• Set a reminder on your phone or mark it on a to-do list
• 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.

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.

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.

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

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 or actions. REXULTI is not approved for use in people less than 18 years of age with MDD.
• 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; or 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 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 (non-therapeutic 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.

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.

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

In a 6-week clinical trial,* adult patients with shifts in fasting blood sugar from normal (<100 mg/dL) to high (≥126 mg/dL) and borderline (≥100 and <126 mg/dL) to high were similar in patients treated with REXULTI and patients treated with placebo (non-therapeutic pill).

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.

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 two 6-week clinical trials,* changes in fasting total cholesterol, LDL-cholesterol, and HDL cholesterol were similar between adult patients taking REXULTI and patients taking a placebo (non-therapeutic pill).

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 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 (non-therapeutic pill).

In two 6-week clinical trials,* 4% of adult patients who had REXULTI added to an antidepressant experienced drowsiness compared to 1% of patients taking an antidepressant plus a placebo (non-therapeutic pill).

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

About 3% of adult patients taking REXULTI plus an antidepressant reported feelings of restlessness during two 6-week clinical trials,* compared to 0% of patients taking placebo (non-therapeutic pill).

Overall, there was no difference seen in sexual function of patients as a result of taking REXULTI with an antidepressant compared to those taking an antidepressant alone.

During two 6-week clinical trials,* adult patients taking REXULTI plus an antidepressant reported their overall sexual function was similar to that of patients taking an antidepressant alone, as measured by the Massachusetts General Hospital Sexual Functioning Questionnaire.