Episode 2 – Is there more I can do for my depression? [Video]

REXULTI® (brexpiprazole), when added to an antidepressant, is proven to reduce depression symptoms in adults with major depressive disorder. Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING at bit.ly/2wdl2FI, and MEDICATION GUIDE at bit.ly/2xclKmJ.

See Important Safety Information below.

INDICATION AND IMPORTANT SAFETY INFORMATION:

INDICATION:
REXULTI® (brexpiprazole) 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:
• 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.

• 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. Pay close attention to all patients on antidepressants for any 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: high fever; changes in your pulse, blood pressure, heart rate, and breathing; stiff muscles; confusion; increased sweating
• Uncontrolled body movements (tardive dyskinesia or TD) in your face, tongue, or other body parts. TD may not go away, even if you stop taking REXULTI. TD may also start after you stop taking REXULTI.
• Problems with your metabolism: 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 monitor your blood sugar. Increased fat levels (cholesterol and triglycerides) in your blood or weight gain.
• Unusual and uncontrollable (compulsive) urges. Some people taking REXULTI have had new or unusual strong urges or behaviors, to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating.
• Low white blood cell count.
• Decreased blood pressure (orthostatic hypotension) and fainting.
• 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 that can cause food or liquid to get into your lungs.
• Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities. Until you know how REXULTI affects you, do not drive, operate machinery, or do dangerous activities. 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. Tell your doctor about all the medicines you take, since there are some risks for drug interaction.

You may report side effects to the FDA at 1-800-FDA-1088.

Please read FULL PRESCRIBING INFORMATION, including BOXED WARNING at bit.ly/2wdl2FI, and MEDICATION GUIDE at bit.ly/2xclKmJ.

May 2024 11US24EBC0118