When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to brexpiprazole.

How to Use This Medicine:
Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how brexpiprazole works. Tell your doctor if you are using any of the following:
  
  • Clarithromycin, duloxetine, fluoxetine, itraconazole, ketoconazole, paroxetine, quinidine, rifampin, St John wort
  • Blood pressure medicine

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, heart failure, heart or blood vessel disease, high cholesterol, or a history of seizures, heart attack, or stroke. Tell your doctor if you have trouble swallowing.
• For some children, teenagers, and young adults, this medicine may increase mental or emotional problems. This may lead to thoughts of suicide and violence. Talk with your doctor right away if you have any thoughts or behavior changes that concern you. Tell your doctor if you or anyone in your family has a history of bipolar disorder or suicide attempts.
• This medicine may cause the following problems:
  
  • Neuroleptic malignant syndrome, a neurologic disorder that can be life-threatening
  • Tardive dyskinesia (muscle movements you cannot control)
  • Changes in blood sugar levels
• This medicine may make you dizzy or drowsy. Do not drive or do anything that could be dangerous until you know how this medicine affects you. Stand or sit up slowly if you feel lightheaded or dizzy.
• You may get overheated more easily while you are using this medicine. Use caution when you exercise or if you are outside in hot weather. Drink plenty of water to stay hydrated.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, irritability, nervousness, restlessness, trouble sleeping
• Fever, chills, cough, sore throat, body aches
• Fever, confusion, sweating, uneven heartbeat, muscle stiffness
• Increased hunger or thirst, increased urination, unusual weakness
• Jerky muscle movements you cannot control (often in your face, tongue, or jaw)
• Lightheadedness, dizziness, fainting
• Seizures
• Worsening depression, unusual behavior, thoughts of hurting yourself

If you notice these less serious side effects, talk with your doctor:

• Tiredness
• Unusual weight gain

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088