aripiprazole (injection)

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

What is aripiprazole?

The Abilify Maintena brand of aripiprazole is used to treat schizophrenia and bipolar I disorder (manic depression) in adults. The Aristada brand of this medicine is for use only in treating schizophrenia in adults.

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 (Abilify) before.

Tell your doctor if you have ever had:

• a problem with your arm or buttocks where an injection will be given;
• heart disease, heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure; or
• low white blood cell (WBC) counts.

Aripiprazole may cause you to have high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are receiving aripiprazole.

Using 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 using aripiprazole 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.

How is aripiprazole given?

Aripiprazole is injected into a muscle. A healthcare provider will give you this injection once every 4 to 8 weeks, depending on your condition. Your doctor may occasionally change your dosing schedule.

If you have never used aripiprazole before, your doctor may want to you also take this medicine by mouth (in tablet or liquid form) for a short time before your first injection. You may need to continue taking oral aripiprazole for up to 3 weeks after your first injection. Follow your doctor's dosing instructions very carefully.

Keep using all your anti-psychotic medications as directed by your doctor. Read the instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Your doctor will need to check your progress while you are using aripiprazole.

What happens if I miss a dose?

What happens if I overdose?

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, or fainting.

What should I avoid while 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 diabetic or an older adult.

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling uncomfortably warm or hot;
• trouble swallowing;
• a seizure;
• 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 --sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, swollen gums, skin sores, cold or flu symptoms, cough, trouble breathing; or
• high blood sugar --increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

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.

Common side effects may include:

• feeling restless;
• pain where the injection was given;
• 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 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.

Many drugs can affect aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about aripiprazole.