Brexpiprazole

IMPORTANT WARNING:

Important warning for older adults with dementia:

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as brexpiprazole have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or ministroke during treatment with antipsychotics.

Brexpiprazole is not approved by the Food and Drug Administration (FDA) for the treatment of people with dementia-related psychosis who do not have agitation. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking brexpiprazole. For more information visit the FDA website: http://www.fda.gov/Drugs.

Important warning for people who have depression:

A small number of children, teenagers, and young adults (up to 24 years of age) who took medications for depression during clinical studies became suicidal (thinking about harming or killing oneself or planning or trying to do so). Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, teenagers, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure about how great this risk is and how much it should be considered in deciding whether a child or teenager should take an antidepressant. Children younger than 18 years of age should not normally take brexpiprazole to treat depression, but in some cases, a doctor may decide that brexpiprazole is the best medication to treat a child's condition.

You should know that your mental health may change in unexpected ways when you take brexpiprazole or other antidepressants even if you are an adult over age 24. You may become suicidal, especially at the beginning of your treatment and any time that your dose is increased or decreased. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; new or worsening anxiety; thinking about harming or killing yourself, or planning or trying to do so; extreme worry; agitation; panic attacks; difficulty falling asleep or staying asleep; aggressive behavior; irritability; acting without thinking; severe restlessness; and mania (frenzied, abnormally excited mood). Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Talk to your doctor about the risk(s) of taking brexpiprazole.

WHY is this medicine prescribed?

Brexpiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) in adults and children 13 years of age and older. It is also used with an antidepressant to treat depression when symptoms cannot be controlled by the antidepressant alone. Brexpiprazole is also used to treat agitation in people with dementia due to Alzheimer's disease (a brain disease that slowly destroys the memory and ability to think, learn, communicate, and handle daily activities). Brexpiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Brexpiprazole comes as a tablet to take by mouth. It is usually taken once daily with or without food. Take brexpiprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take brexpiprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of brexpiprazole and gradually increase your dose depending on how well the medication works for you and the side effects you experience.

Brexpiprazole may control your symptoms but will not cure your condition. Continue to take brexpiprazole even if you feel well. Do not stop taking brexpiprazole without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking brexpiprazole,

• tell your doctor and pharmacist if you are allergic to brexpiprazole, any other medications, or any of the ingredients in brexpiprazole tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking brexipiprazole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal products may interact with brexpiprazole: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start taking brexpiprazole. Do not start this medication while taking brexpiprazole without discussing with your healthcare provider.

• tell your doctor or if you or anyone in your family has or has ever had diabetes. Tell you doctor if you have or have ever had a stroke, a ministroke (TIA), chest pain, heart disease, a heart attack, an irregular heartbeat, heart failure, trouble keeping your balance, any condition that makes it difficult for you to swallow, high or low blood pressure, seizures, a high level of fats (cholesterol and triglycerides) in your blood, a low number of white blood cells, or kidney or liver disease. Also tell your doctor if you have severe vomiting or diarrhea or signs of dehydration now, or if you develop these symptoms at any time during your treatment.

• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breastfeeding. If you become pregnant while taking brexpiprazole, call your doctor. Brexpiprazole may cause problems in newborns following delivery if it is taken during the last months of pregnancy.

• you should know that brexpiprazole may make you drowsy and may affect your ability to think clearly and react quickly. Do not drive a car or operate hazardous machinery and take precautions to avoid falls until you know how this medication affects you.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking brexpiprazole or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking brexpiprazole: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that brexpiprazole may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking brexpiprazole. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that some people who used medications such as brexpiprazole developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors, excessive shopping, and binge eating. Call your doctor if you have intense urges to shop, eat, have sex, or gamble, or if you are unable to control your behavior. Tell your family members about this risk so that they can call the doctor even if you do not realize that your gambling or any other intense urges or unusual behaviors have become a problem.

• you should know that brexpiprazole may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to exercise or be exposed to extreme heat.

• you should know that brexpiprazole may cause an increase in weight. It is important to have your weight checked periodically while you are taking this medication.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Brexpiprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• constipation
• diarrhea
• heartburn
• increased appetite
• tiredness
• uncontrollable shaking of a part of the body
• dizziness, feeling unsteady, or having trouble keeping your balance

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNINGS and SPECIAL PRECAUTIONS sections, call your doctor immediately:

• rash
• hives
• itching
• swelling of the eyes, face, mouth, lips, tongue, throat, hands, feet, ankles, or lower legs
• difficulty breathing or swallowing
• seizures
• shortness of breath
• sore throat, cough, fever, chills, difficult or painful urination, or other signs of infection
• fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
• unusual movements of your face or body that you cannot control
• falling
• tightening of the neck muscles or throat

Brexpiprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to brexpiprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.