Brexpiprazole

Generic name: Brexpiprazole
Brand names: Rexulti
Dosage form: oral tablet (0.25 mg; 0.5 mg; 1 mg; 2 mg; 3 mg; 4 mg)
Drug class: Atypical antipsychotics

Usage of 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.

Brexpiprazole side effects

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.

    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 brexpiprazole. Ask your doctor about any risk.

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

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    How to use Brexpiprazole

    Usual Adult Dose for Schizophrenia:

    Initial dose: 1 mg orally once a day on Days 1 through 4Titration: 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 8Target Dose: 2 to 4 mg orally once a dayMaximum dose: 4 mg/dayUse: Treatment of schizophrenia

    Usual Adult Dose for Depression:

    Initial dose: 0.5 mg or 1 mg orally once a dayTitration: 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 dayMaximum dose: 3 mg/dayUse: 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 4Titration: 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 dayMaximum dose: 4 mg/dayUse: Treatment of schizophrenia in children 13 to 17 years of age

    Warnings

    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 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.

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