Abilify Maintena and Abilify Asimtufii are used in adults to treat schizophrenia and bipolar disorder.

Aristada is used in adults to treat schizophrenia.

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

Aristada Initio may also be used for purposes not listed in this medication guide.

Aristada Initio is not approved for use in older adults with dementia-related psychosis.

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 Initio, you may need to take this medicine by mouth (in tablet or liquid form) before you receive your first injection.

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

Aristada Initio 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.

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

Tell your doctor if you have never taken Aristada Initio.

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

Tell your doctor if you have or 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 Aristada Initio.

Call your doctor for instructions if you miss an appointment for your Aristada Initio.

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 Aristada Initio 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 Initio.

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 aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use Aristada Initio, 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 Aristada Initio. Talk with your doctor if this occurs.

Aristada Initio 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 side effects of Aristada Initio 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 Aristada Initio, 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 affect Aristada Initio. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.