What is the most important information I should know about brexpiprazole?
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.
What is brexpiprazole?
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.
What should I discuss with my healthcare provider before taking brexpiprazole?
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 this medicine. Ask your doctor about any risk.
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 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.
What happens if I miss a dose?
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.
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?
Avoid driving or hazardous activity until you know how this medicine 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.
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.
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.
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 this medicine. Talk with your doctor if this occurs.
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?
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.
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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