Aripiprazole Injection

IMPORTANT WARNING:

Older adults with dementia (loss of memory and brain function) have an increased chance of death if treated with antipsychotic medications such as aripiprazole.Older adults with dementia may also have an increased risk of a stroke or ministroke during treatment with antipsychotics.

Aripiprazole extended-release (long-acting) injection is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia.

Your doctor or pharmacist will give you the Medication Guide when you begin treatment with aripiprazole extended-release injection and each time you receive an injection. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Talk to your doctor about the risks of receiving aripiprazole extended-release injection.

WHY is this medicine prescribed?

Aripiprazole extended-release injection is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves) and bipolar I disorder (a disease that causes depression, mania, and other abnormal moods).Aripiprazole is in a class of medications called atypical antipsychotics.It works by changing the activity of certain natural substances in the brain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Aripiprazole extended-release injection comes as a powder to be mixed with water and as a suspension (liquid) to be injected into a muscle by a healthcare provider.

Aripiprazole extended-release injection is usually given once every 4, 6, or 8 weeks, depending on the specific product given. If you have never received aripiprazole previously, your doctor will tell you to take aripiprazole tablets by mouth for up to 2 weeks before you receive your first injection.You may also need to take aripiprazole tablets or another antipsychotic medication by mouth for the first several weeks right after receiving your first injection of aripiprazole extended-release injection.

Aripiprazole extended-release injection may help control your symptoms but will not cure your condition. Continue to keep appointments to receive aripiprazole extended-release injection even if you feel well. Talk to your doctor if you do not feel like you are getting better during your treatment with aripiprazole extended-release injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving aripiprazole extended-release injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any otherdrugs, foods or substances.Tell your doctor or pharmacist about the allergy and whatsymptoms you had.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• The following nonprescription or herbal product may interact with aripiprazole: St. John's wort. Be sure to let your healthcare provider know that you are taking this medication before you start taking aripiprazole. Do not start this medication while taking aripiprazole without talking to your healthcare provider.

• tell your doctor if you have severe diarrhea or vomiting or you think you may be dehydrated. Also tell your doctor if you have or have ever had heart disease, heart failure, a heart attack, an irregular heartbeat, high or low blood pressure, a stroke, a ministroke, seizures, a low number of white blood cells,dyslipidemia (high cholesterol levels),trouble keeping your balance, or any condition that makes it difficult for you to swallow. Tell your doctor if you or anyone in your family use or have ever used street drugs or have overused prescription medication or alcohol or has or has ever had diabetes, obsessive compulsive disorder, impulse-control disorder, bipolar disorder, or an impulsive personality. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.

• tell your doctor if you are pregnant, if you plan to become pregnant, or if you are breastfeeding.If you become pregnant during your treatment with aripiprazole, call your doctor. Aripiprazole may cause problems in newborns following delivery if it is given during the last months of pregnancy.

• you should know that receiving aripiprazole extended-release injection may make you drowsy and may affect your ability to think clearly, make decisions, and react quickly.Do not drive a car or operate machinery until you know how this medication affects you.

• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol during your treatment with aripiprazole.

• you should know that aripiprazole extended-release injection may cause dizziness, lightheadedness, fast or slow heartbeat, and fainting when you get up too quickly from a lying position, especially right after you receive your injection.If you feel dizzy or drowsy after you receive your injection, lie down until you feel better. During your treatment, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are receiving this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and receiving aripiprazole extended-release injection or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms during your treatment: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that some people who used medications such as aripiprazole extended-release injection developed gambling problems or other intense urges or behaviors that were compulsive or unusual for them, such as increased sexual urges or behaviors, excessive shopping, and binge eating.Call your doctor if you have intense urges to shop, eat, have sex, or gamble, or if you are unable to control your behavior.Tell your family members about this risk so that they can call the doctor even if you do not realize that these behaviors have become a problem.

• you should know that aripiprazole extended-release injection may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.Be sure to drink plenty of water and call your doctor if you experience any of the following symptoms: feeling very hot, sweating heavily, not sweating even though it is hot, dry mouth, excessive thirst, or decreased urination.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about drinking grapefruit juice and eating grapefruit while receiving this medicine.

Be sure to drink plenty of water every day while you are receiving this medication.

What should I do IF I FORGET to take a dose?

If you forget to keep an appointment to receive aripiprazole extended-release injection, call your doctor to schedule another appointment as soon as possible.

What SIDE EFFECTS can this medicine cause?

Aripiprazole extended-release injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, swelling, redness at injection site
• weight gain
• headache
• extreme tiredness
• stomach pain
• constipation
• vomiting
• dry mouth
• back, muscle, or joint pain
• difficulty falling asleep or staying asleep
• dizziness, feeling unsteady, or having trouble keeping your balance

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• rash
• itching
• hives
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, and/or lower legs
• swollen lymph nodes
• difficulty swallowing or breathing
• muscle stiffness
• excessive sweating
• irregular heartbeat
• confusion
• falling
• unusual movements of the face or body that you cannot control
• uncontrollable shaking of a part of the body
• restlessness
• need to get up and move
• slow movements
• sore throat, fever, chills, or other signs of infection
• seizures

Aripiprazole extended-release injection may cause other side effects. Call your doctor if you have any unusual problems while you are receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• confusion
• disorientation
• vomiting
• slowed or uncontrollable movements
• drowsiness
• seizures
• aggressive behavior
• coma (loss of consciousness for a period of time)

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to aripiprazole extended-release injection.

Ask your pharmacist any questions you have about aripiprazole extended-release injection.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicinesvitamins, minerals, and dietary supplements you are taking. Bring this list with you each timeyou visit a doctor or if you are admitted to the hospital. You should carry the list with you incase of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.