IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
ARIPIPRAZOLE EXTENDED RELEASE - INJECTION
COMMON BRAND NAME(S): Abilify Maintena
WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.
USES: Extended-release aripiprazole injection is used to treat a mental/mood disorder called schizophrenia. This medication can decrease hallucinations (hearing/seeing things that are not there) and improve your concentration. It also helps you to think more clearly, feel less nervous, and take a more active part in everyday life. Extended-release aripiprazole injection is a long-acting psychiatric medication known as an atypical antipsychotic. It works by helping to restore the balance of certain natural substances in the brain.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using aripiprazole and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
The extended-release injection should only be used if you have already taken aripiprazole by mouth without any serious side effects.
Aripiprazole is given by injection into the buttock muscle by a health care professional, usually once every month. Do not rub/massage the injection site after your dose.
After your first injection, your doctor may direct you to continue to take your antipsychotic medication by mouth (such as aripiprazole tablet/solution) for 2 weeks. This will help maintain the right level of medication in your body as you switch from receiving medication by mouth to receiving it by injection. Follow your doctor's instructions carefully.
The dosage is based on your medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
It may take several weeks to get the full benefit of this medication. Use this medication regularly to get the most benefit from it. To help you remember, mark the days on the calendar when you need to receive the medication.
Tell your doctor if your condition does not improve or if it worsens.
Dizziness, lightheadedness, drowsiness, tiredness, blurred vision, weight gain, shaking (tremors), and redness/pain/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: fainting, trouble swallowing, restlessness (especially in the legs), seizures, signs of infection (such as fever, persistent sore throat).
This medication may infrequently make your blood sugar level rise, which can cause or worsen diabetes. Rarely, very serious conditions such as diabetic coma may occur. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst and urination. If you already have diabetes, be sure to check your blood sugars regularly. Your doctor may need to adjust your diabetes medication, exercise program, or diet.
This medication may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).
This medication may rarely cause a serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you develop any of the following: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in amount of urine.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Abilify Maintena (aripiprazole extended-release injectable suspension) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: See also Warning and Side Effects sections.
Before using aripiprazole, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: problems with receiving injections into the buttocks, problems with blood flow in the brain (such as cerebrovascular disease, stroke), blood clotting problems (such as hemophilia, low platelets), diabetes (including family history), heart problems (such as low blood pressure, coronary artery disease), nervous system problems (such as dementia, NMS, seizures), obesity, low white blood cell count (including history of low white blood cell count caused by medications), swallowing problems.
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the side effects of this drug, especially seizures, drowsiness, confusion, tardive dyskinesia, swallowing problems, and other serious (rarely fatal) side effects. (See also Warning section.) Drowsiness and confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.
Since untreated mental/mood problems (such as schizophrenia) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.
This medication passes into breast milk. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
A product that may interact with this drug is: metoclopramide.
Other medications can affect the removal of aripiprazole from your body, which may affect how aripiprazole works. Examples include carbamazepine, among others.
Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: very fast heartbeat, loss of consciousness.
NOTES: Laboratory and/or medical tests (such as blood sugar, weight, cholesterol/triglyceride levels) may be performed from time to time to monitor your progress or check for side effects. Consult your doctor for more details.
MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Your doctor may direct you to also take aripiprazole by mouth for 2 weeks if more than 5 to 6 weeks have passed since your last injection.
STORAGE: Not applicable. This medication is given in a hospital or clinic and will not be stored at home.
Information last revised March 2015. Copyright(c) 2015 First Databank, Inc.