aripiprazole (injection)

What is the most important information I should know about aripiprazole?

What is aripiprazole?

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 aripiprazole to start or restart Aristada.

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

What should I discuss with my healthcare provider before receiving aripiprazole?

Tell your doctor if you have never taken aripiprazole.

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 this medicine.

How is aripiprazole given?

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 aripiprazole, 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.

Aripiprazole 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.

What happens if I miss a dose?

What happens if I overdose?

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.

What should I avoid while receiving aripiprazole?

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

What are the possible side effects of aripiprazole?

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use aripiprazole, 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.

• 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 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.

What other drugs will affect aripiprazole?

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 affect aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your doctor or pharmacist can provide more information about aripiprazole.

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.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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