Brexpiprazole : Uses, Side Effects, Interactions & More

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 can cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as brexpiprazole. you have a higher chance of death during treatment. Older adults with dementia may also have a higher chance of having a stroke or mini-stroke during antipsychotic treatment.

Brexpiprazole is not approved by the Food and Drug Administration (FDA) for the treatment of behavioral disorders in older adults with dementia. Talk to the doctor who prescribed this medicine if you, a family member, or a loved one have dementia and are 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, adolescents, and young adults (up to age 24) who took medications for depression during clinical trials became suicidal (thinking about harming or killing themselves or planning or trying to do so). Children, adolescents, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal than children, adolescents, and young adults who do not take antidepressants to treat these conditions. However, experts are not sure how great this risk is and how much should be taken into account when deciding whether a child or adolescent should take an antidepressant. Children under 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 medicine for treating a child’s condition.

You should know that your mental health can change unexpectedly when you take brexpiprazole or other antidepressants, even if you are an adult over 24 years of age. You may be suicidal, especially at the beginning of your treatment and any time the 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, or planning or attempting to, hurt or commit suicide; extreme worry; agitation; panic attacks; Difficulty falling asleep or staying asleep; aggressive behavior; irritability; act without thinking; severe restlessness; and mania (frenzied and abnormally excited mood). Make sure your family or caregiver knows what symptoms can be serious so they can call your doctor if you are unable to seek treatment on your own.

Talk to your doctor about the risks of taking brexpiprazole.

Brexpiprazole is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thoughts, loss of interest in life, and strong or inappropriate emotions). It is also used with an antidepressant to treat depression when symptoms cannot be controlled with the antidepressant alone. Brexpiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Brexpiprazole comes as a tablet to take by mouth. It is usually taken once a day. Take brexpiprazole at around the same times every day. Follow the directions on your prescription label carefully and ask your doctor or pharmacist to explain any parts you do not understand. Take Brexpiprazole exactly as directed. Do not take more or less, 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 medicine works for you and the side effects you experience.

Brexpiprazole controls schizophrenia and depression but does not cure these conditions. Keep taking brexpiprazole even if you feel fine. Do not stop taking brexpiprazole without consulting your doctor.

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

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 other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: antidepressants such as duloxetine (Cymbalta), fluoxetine (Prozac, Sarafem, Symbyax), and paroxetine (Brisdelle, Paxil); certain antifungal medications such as fluconazole (Diflucan), itraconazole (Onmel, Sporanox), and ketoconazole (Extina, Nizoral, Xolegel); clarithromycin (Biaxin, in Prevpac); medications to control high blood pressure; quinidine (in Nuedexta); and rifampicin (Rifadin, Rimactane, in Rifamate, Rifater). Your doctor may need to change the doses of your medications or monitor you closely for side effects. Many other medications can also interact with brexpiprazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• Tell your doctor what herbal products you are taking, especially St. John’s wort.
• Tell your doctor or if you or anyone in your family has or has ever had diabetes. Tell your doctor if you have or have ever had a stroke, mini-stroke (TIA), chest pain, heart disease, heart attack, irregular heartbeat, heart failure, trouble keeping your balance, any condition that difficulty swallowing, high or low blood pressure, seizures, a high level of fats (cholesterol and triglycerides) in the 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 at this time, 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 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 can cause problems in newborns after delivery if taken during the last months of pregnancy.
• You should know that brexpiprazole may make you drowsy. Do not drive a car or operate dangerous machinery until you know how this medicine affects you.
• You should know that you may experience hyperglycemia (increased blood sugar) while taking this drug, 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 can increase this risk. Tell your doctor right away if you have any of the following symptoms while taking brexpiprazole: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important that you call your doctor as soon as you have any of these symptoms, because high blood sugar levels can cause a serious condition called ketoacidosis. Ketoacidosis can be life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, fruity breath odor, and decreased consciousness.
• You should know that brexpiprazole can cause dizziness, lightheadedness, and fainting when you get up too quickly from lying down. This is more common when you 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 brexpiprazole can make it difficult for your body to cool down in very hot weather. Tell your doctor if you plan to exercise or be exposed to extreme heat.
• You should know that brexpiprazole can cause weight gain. It is important to check your weight regularly while you are taking this medicine.

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

Take the missed dose as soon as you remember. 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 the one you forgot.

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

• headache
• constipation
• heartburn
• 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, chills, and 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
• tightness in the throat

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

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

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

Unnecessary medications must be disposed of in special ways to ensure they cannot be consumed by pets, children, and others. However, you should not flush this medicine down the toilet. Instead, the best way to dispose of your medications is through a drug take-back program. Talk to your pharmacist or contact your local garbage / recycling department to find out about take-back programs in your community. See the FDA Safe Drug Disposal 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 medicines out of the sight and reach of children, since many containers (such as those containing weekly pills and those for eye drops, creams, patches and inhalers) are not resistant to children and small children can easily open them. To protect young children from poisoning, always close the safety caps and immediately place the medicine in a safe place, one that is upright and out of their sight and reach. http://www.upandaway.org

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 collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.

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 medicine. Ask your pharmacist any questions you have about refilling your prescription.

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