Rexulti is a prescription antipsychotic medication used in the treatment of major depressive disorder, schizophrenia, and agitation associated with dementia due to Alzheimer’s disease.

The exact way Rexulti works is unknown, but it is thought to work by changing the actions of serotonin and dopamine, which are chemicals in the brain.

What is Rexulti used to treat?

Rexulti is used together with antidepressant medicines to treat major depressive disorder in adults.

Rexulti is used to treat schizophrenia in adults and children ages 13 years and older.

Rexulti is also used treat agitation that may happen with dementia due to Alzheimer’s disease.

Rexulti 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.

It is not known if Rexulti is safe and effective in children with major depressive disorder. It is not known if it is safe and effective in children under 13 years of age with schizophrenia.

Take Rexulti exactly as prescribed by your doctor. 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 Rexulti with or without food.

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

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

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

Store at room temperature away from moisture and heat.

Usual Adult Dose for Major Depressive Disorder:

Initial dose: 0.5 mg to 1 mg orally once a day
Titration regimen: 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.
Maintenance dose: 2 mg orally once a day
Maximum dose: 3 mg/day

Comment: Healthcare providers should periodically reassess the need for maintenance treatment.

Use: Adjunctive treatment of major depressive disorder (MDD)

Usual Adult Dose for Schizophrenia:

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

Use: Treatment of schizophrenia

Usual Adult Dose for Agitation Associated with Dementia Due to Alzheimer’s Disease:

Initial dose: 0.5 mg orally once a day on Days 1 through 7
Titration regimen: Based on clinical response and tolerability, titrate to 1 mg once a day on Days 8 to 14, then to 2 mg once a day on Day 15.
Maintenance dose: 2 mg orally once a day
Maximum dose: 3 mg/day based on clinical response and tolerability after at least 14 days

Use: Treatment of agitation associated with dementia due to Alzheimer’s disease

Usual Pediatric Dose for Schizophrenia:

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

Use: Treatment of schizophrenia in pediatric patients ages 13-17 years

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

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

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 Rexulti 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 breast-feed while using this medicine. Ask your doctor about any risk.

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.

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.

Get emergency medical help if you have signs of an allergic reaction to Rexulti: 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 Rexulti can cause a serious movement disorder that may not be reversible. The longer you use this medicine, 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 Rexulti 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.

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 interact with 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.