Brexpiprazole is an antipsychotic medication that is used to treat the symptoms of schizophrenia. It is also used together with other medications to treat major depressive disorder in adults.

Brexpiprazole may also be used for purposes not listed in this medication guide.

Brexpiprazole is not approved for use in older adults with dementia-related psychosis.

Some young people have thoughts about suicide when first taking this medicine. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Brexpiprazole is not approved for use by anyone younger than 18 years old.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may take brexpiprazole with or without food.

Drink plenty of fluids, especially in hot weather and during exercise. You may get dehydrated easily while taking brexpiprazole.

You should not stop using brexpiprazole suddenly. Stopping suddenly may make your condition worse.

Brexpiprazole may cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking brexpiprazole.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Schizophrenia:

Initial dose: 1 mg orally once a day on Days 1 through 4
Titration: Based on clinical response and tolerability, titrate to 2 mg once a day on Day 5 through Day 7, then to 4 mg once a day on Day 8
Target Dose: 2 to 4 mg orally once a day
Maximum dose: 4 mg/day

Use: Treatment of schizophrenia

Usual Adult Dose for Depression:

Initial dose: 0.5 mg or 1 mg orally once a day
Titration: Based on clinical response and tolerability, dose increases should be done at weekly intervals; titrate to 1 mg once a day, then up 2 mg once a day.
Target dose: 2 mg orally once a day
Maximum dose: 3 mg/day

Use: Adjunctive treatment of major depressive disorder (MDD)

Usual Pediatric Dose for Schizophrenia:

Initial dose: 0.5 mg orally once a day on Days 1 through 4
Titration: Based on clinical response and tolerability, titrate to 1 mg once a day on Day 5 through Day 7, then to 2 mg once a day on Day 8. Weekly dose increases can be made in 1 mg increments.
Target Dose: 2 to 4 mg orally once a day
Maximum dose: 4 mg/day

Use: Treatment of schizophrenia in children 13 to 17 years of age

Brexpiprazole may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

You should not use brexpiprazole if you are allergic to it.

Tell your doctor if you have ever had:

• diabetes or high blood sugar;

• liver disease;

• kidney disease;

• high cholesterol or triglycerides (a type of fat in the blood);

• heart problems, high or low blood pressure;

• heart attack or stroke;

• a seizure; or

• low white blood cell (WBC) counts.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking brexpiprazole without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of brexpiprazole on the baby.

It may not be safe to breastfeed while using brexpiprazole. Ask your doctor about any risk.

Brexpiprazole is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Avoid driving or hazardous activity until you know how brexpiprazole will affect you. Your reactions could be impaired.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated in hot weather. Brexpiprazole can make it harder for your body to control its own temperature. It is easier to become dangerously overheated and dehydrated while you are taking this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of brexpiprazole can cause a serious movement disorder that may not be reversible. The longer you use brexpiprazole, the more likely you are to develop this disorder, especially if you are a diabetic or an older adult.

Brexpiprazole may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• trouble swallowing;

• feelings of warmth, intolerance to heat;

• a seizure (convulsions);

• a light-headed feeling, like you might pass out;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• low white blood cell counts--fever, mouth sores, skin sores, sore throat, cough, trouble breathing;

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors; or

• signs of a blood clot--sudden numbness or weakness, problems with vision or speech, swelling or redness in an arm or leg.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking brexpiprazole. Talk with your doctor if this occurs.

Common side effects of brexpiprazole may include:

• weight gain; or

• feeling restless or being unable to sit still.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Other drugs may affect brexpiprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

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.