brexpiprazole

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Pronunciation: brex PIP ra zole

Brand: Rexulti

What is the most important information I should know about brexpiprazole?

Brexpiprazole is not approved for use in psychotic conditions related to dementia.

Some young people have thoughts about suicide when first taking an antidepressant. 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.

What is brexpiprazole?

Brexpiprazole is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Brexpiprazole 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.

What should I discuss with my healthcare provider before taking brexpiprazole?

Brexpiprazole is not approved for use in psychotic conditions related to dementia. Brexpiprazole may increase the risk of death in older adults with dementia-related conditions.

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

To make sure brexpiprazole is safe for you, tell your doctor if you have:

  • liver disease;
  • kidney disease;
  • high cholesterol or triglycerides (a type of fat in the blood);
  • heart disease, high or low blood pressure;
  • a history of low white blood cell (WBC) counts;
  • a history of heart attack or stroke;
  • a history of seizures, head injury or brain tumor;
  • a personal or family history of diabetes or high blood sugar; or
  • trouble swallowing.

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.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

If you are pregnant, your name may be listed on a pregnancy registry. This is to track the outcome of the pregnancy and to evaluate any effects of brexpiprazole on the baby.

It is not known whether brexpiprazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

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

How should I take brexpiprazole?

Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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 you to have 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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

What should I avoid while taking brexpiprazole?

Brexpiprazole may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

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.

What are the possible side effects of brexpiprazole?

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

High doses or long-term use of brexpiprazole can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take brexpiprazole, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

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.

Call your doctor at once if you have:

  • severe agitation, distress, or restless feeling;
  • a light-headed feeling, like you might pass out;
  • trouble swallowing;
  • feelings of warmth, intolerance to heat;
  • thoughts about suicide or hurting yourself;
  • twitching or uncontrolled muscle movements;
  • a seizure (convulsions);
  • high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, weight loss;
  • low blood cell counts --sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, red or swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or
  • a severe nervous system reaction --very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects 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.

What other drugs will affect brexpiprazole?

Many drugs can interact with brexpiprazole. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any you start or stop using, especially:

  • an antibiotic or antifungal medicine;
  • an antidepressant;
  • antiviral medicine to treat hepatitis C or HIV;
  • heart rhythm medicine; or
  • seizure medicine.

This list is not complete and many other drugs can interact with brexpiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about brexpiprazole.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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