Aristada (aripiprazole) is used in adults to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions).

Aristada Initio is used together with oral aripiprazole to start or restart Aristada.

Aristada belongs to a class of medications called atypical antipsychotics. Aripiprazole works by changing the activity of certain natural substances in the brain.

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

Before taking this medicine

You should not be treated with Aristada if you are allergic to aripiprazole.

Tell your doctor if you have never taken Aristada.

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a problem in receiving an injection in the arm or buttocks;

• heart disease, a heart attack or stroke;

• high or low blood pressure;

• high blood sugar, diabetes (in you or family member);

• a seizure;

• high cholesterol or triglycerides;

• dehydration; or

• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Use Aristada as prescribed by your doctor. If you already use other antipsychotic medication, you may need to keep using it for a short time. Do not change your dose or dosing schedule without your doctor's advice.

If you have never used Aristada, you may need to take aripiprazole by mouth (in tablet or liquid form) before you receive your first injection.

You may need to continue taking aripiprazole by mouth for up to 3 weeks after your first injection. Follow your doctor's dosing instructions very carefully.

Aristada is injected into a muscle. A healthcare provider will give you this injection once every 4 to 8 weeks. Your doctor may occasionally change your dose and dosing schedule.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Usual Adult Dose for Schizophrenia:

Aripiprazole Lauroxil Extended-Release IM Suspension:
-Initial dose:
-Patients stable on oral aripiprazole IR 10 mg/day: 441 mg IM via deltoid or gluteal injection ONCE PLUS aripiprazole lauroxil 675 mg IM ONCE OR aripiprazole IR 10 mg orally once a day for 21 days
-Patients stable on oral aripiprazole IR 15 mg/day: Initial dose 662 mg IM via gluteal injection ONCE PLUS aripiprazole lauroxil 675 mg IM ONCE OR aripiprazole IR 15 mg orally once a day for 21 days
-Patients stable on oral aripiprazole IR at least 20 mg/day: 882 mg IM via gluteal injection ONCE PLUS aripiprazole lauroxil 675 mg IM ONCE OR aripiprazole IR once a day for 21 days.
-Maintenance doses: 441 mg, 662 mg, or 882 mg IM monthly, 882 mg IM every 4 to 6 weeks, or 1064 mg IM every 2 months; this drug should not be given sooner than 14 days after the previous injection.

Re-initiation of treatment: Aristada Initio 675 mg IM ONCE plus 30 mg of aripiprazole IR orally ONCE

Comments:
Prior to initiating therapy with extended-release IM formulations, tolerability should be established with oral formulations; it may take up to 2 weeks to fully assess tolerability due to the half-life of aripiprazole.
-The first dose of the extended-release IM formulation should be given on the same day as the initiation/re-initiation dose; providers should avoid injecting both formulations in the same deltoid or gluteal muscle.
-Dose regimen adjustments (including addition of oral supplementation) will be needed for missed doses.

You should not be treated with Aristada if you are allergic to aripiprazole.

Tell your doctor if you have never taken Aristada.

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

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• a problem in receiving an injection in the arm or buttocks;

• heart disease, a heart attack or stroke;

• high or low blood pressure;

• high blood sugar, diabetes (in you or family member);

• a seizure;

• high cholesterol or triglycerides;

• dehydration; or

• low white blood cell (WBC) counts.

Using antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using this medicine.

Call your doctor for instructions if you miss an appointment for your aripiprazole injection.

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

Overdose symptoms may include drowsiness, weak or shallow breathing, vomiting, aggression, tiredness, confusion, tremors, fast, slow, or uneven heart rate, a light-headed feeling, high blood pressure, seizures, or fainting.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are receiving Aristada.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

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 Aristada 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 woman or an older adult.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while using this medicine. Talk with your doctor if this occurs.

Aristada 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);

• feeling unusually hot or cold;

• trouble swallowing;

• a seizure;

• feeling like you might pass out (even while lying down);

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor.

Common Aristada side effects may include:

• feeling restless;

• pain where the medicine was injected;

• weight gain; or

• drowsiness.

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 medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect aripiprazole, especially:

• blood pressure medications;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• bronchodilator asthma medication;

• cold or allergy medicine (Benadryl and others);

• medicine to treat overactive bladder;

• medicine to treat Parkinson's disease; or

• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome.

This list is not complete and many other drugs may interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.