Frequently Asked Questions

Depression is a serious medical condition that affects over 22 million people. It’s a mood disorder that can cause, among other symptoms, persistent feelings of sadness and loss of interest in doing things.

Partial Response is when someone is still experiencing symptoms of depression, even though they are taking an antidepressant. Partial response is very common, so you should talk to your healthcare provider about treatment options if you're still having depression symptoms.

An add-on (also known as adjunctive) prescription medication treatment is used to help patients who are already on another medication for the same condition. It can help improve symptoms, without the patient having to change the medication they are already taking. For instance, REXULTI is an add-on treatment that works alongside all antidepressants to help reduce depression symptoms.

Three important chemicals in the brain help regulate mood: serotonin, dopamine, and norepinephrine. When these levels are out of balance, experts believe it can lead to depression.

REXULTI was specifically designed to have similar activity on serotonin and dopamine receptors. While the exact way REXULTI works is unknown, scientists believe that it may affect serotonin, dopamine, and norepinephrine receptors in a similar way.

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, they 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.

Download the Doctor Discussion Guide before your next visit.

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. Tardive dyskinesia may not go away, even if you stop taking REXULTI. Tardive dyskinesia may also start after you stop taking REXULTI.
• 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.
• 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.

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). No patients discontinued (stopped) the clinical trials due to weight gain.

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).

No patients discontinued (stopped) the clinical trials due to weight gain.

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.