Brexpiprazole

What it is used for

REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease.

REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1, 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years and older ( 1, 14.2 ) Treatment of agitation associated with dementia due to Alzheimer's disease ( 1, 14.3 ) Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease

Side effects, and when to stop

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 develop some or all of the following signs and symptoms of NMS:

high fever stiff muscles confusion

changes in your pulse, blood pressure, heart rate, and breathing 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 develop 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.See " What should I avoid while taking REXULTI?" Difficulty swallowingthat can cause food or liquid to get into your lungs. Sleepiness, drowsiness, feeling tired, difficulty thinking and doing normal activities.See " What should I avoid while taking REXULTI? "

The most common side effects of REXULTI in adultsinclude weight gain, sleepiness, dizziness, common cold symptoms, and restlessness or feeling like you need to move (akathisia). The most common side effects of REXULTI in children 13 to 17 years of ageinclude difficulty moving or slow movement, tremors (shaking), abnormal eye movements, and muscle stiffness. These are not all the possible side effects of REXULTI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store REXULTI?

Store REXULTI at room temperature between 68°F to 77°F (20°C to 25°C).

Keep REXULTI and all medicines out of the reach of children. General information about the safe and effective use of REXULTI. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use REXULTI for a condition for which it was not prescribed. Do not give REXULTI to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about REXULTI that is written for health professionals. What are the ingredients in REXULTI? Active ingredient:brexpiprazole Inactive ingredients:lactose monohydrate, corn starch, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropyl cellulose, magnesium stearate, hypromellose, and talc For color: titanium dioxide, iron oxide, and ferrosoferric oxide

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What to avoid

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. 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.

How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings, or if you develop suicidal thoughts or actions. This is very important when REXULTI or the antidepressant medicine is started or when the dose is changed. Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member have any of the following symptoms, especially if they are new, worse, or worry you:

thoughts about suicide or dying new or worsening depression feeling very agitated or restless trouble sleeping (insomnia) acting aggressive, being angry, or violent an extreme increase in activity or talking (mania)

suicide attempts new or worsening anxiety panic attacks new or worsening irritability acting on dangerous impulses other unusual changes in behavior or mood

See " What are the possible side effects of REXULTI?" for more information about side effects. What is REXULTI? 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 for the treatment of MDD in children. It is not known if REXULTI is safe and effective for the treatment of schizophrenia in children under 13 years of age. Who should not take REXULTI? Do not take REXULTI if youare allergic to brexpiprazole or any of the ingredients in REXULTI. See the end of this Medication Guide for a complete list of ingredients in REXULTI. 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 of 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. How should I 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 REXULTI 1 time each day with or without food. If you take too much REXULTI, call your healthcare provider or Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.