"The US Food and Drug Administration (FDA) announced today that its review of two patients who died after receiving intramuscular injections of the schizophrenia drug olanzapine pamoate (Zyprexa Relprevv, Eli Lilly) is inconclusive, altho"...
(aripiprazole) for Extended-release Injectable Suspension, for Intramuscular Use
Read this Medication Guide before you receive your first injection of ABILIFY MAINTENA and before each injection. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is the most important information I should know about ABILIFY MAINTENA?
ABILIFY MAINTENA may cause serious side effects, including:
- Increased risk of death in elderly people with dementiarelated psychosis. ABILIFY MAINTENA is not for the treatment of people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
- Neuroleptic malignant syndrome (NMS) a serious
condition that can lead to death. Tell your healthcare provider right away if
you have some or all of the following symptoms of NMS:
- high fever
- stiff muscles
- changes in pulse, heart rate, and blood pressure
Call your healthcare provider right away if you have any of these symptoms.
What is ABILIFY MAINTENA?
ABILIFY MAINTENA is a prescription medicine used to treat schizophrenia.
It is not known if ABILIFY MAINTENA is safe and effective in children under 18 years of age.
Who should not receive ABILIFY MAINTENA?
Do not receive ABILIFY MAINTENA if you are allergic to aripiprazole or any of the ingredients in ABILIFY MAINTENA. See the end of this leaflet for a complete list of ingredients in ABILIFY MAINTENA.
What should I tell my healthcare provider before receiving ABILIFY MAINTENA?
Before you receive ABILIFY MAINTENA, tell your healthcare provider if you:
- have never taken ABILIFY (aripiprazole) before
- have diabetes or high blood sugar or a family history of diabetes or high blood sugar. Your healthcare provider should check your blood sugar before you start receiving ABILIFY MAINTENA and during your treatment.
- have or had seizures (convulsions)
- have or had low or high blood pressure
- have or had heart problems or a stroke
- have or had a low white blood cell count
- have any other medical problems including problems that may affect you receiving an injection in your buttocks
- are pregnant or plan to become pregnant. It is not known if ABILIFY MAINTENA will harm your unborn baby.
- are breastfeeding or plan to breastfeed. ABILIFY MAINTENA can pass into your milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ABILIFY MAINTENA.
Tell your healthcare provider about all the medicines you take, including prescription medicines, non-prescription medicines, vitamins, and herbal supplements.
- ABILIFY MAINTENA and other medicines may affect each other causing possible serious side effects. ABILIFY MAINTENA may affect the way other medicines work, and other medicines may affect how ABILIFY MAINTENA works.
- Your healthcare provider can tell you if it is safe to take ABILIFY MAINTENA with your other medicines. Do not start or stop any medicines while taking ABILIFY MAINTENA without talking to your healthcare provider first. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
- How should I receive ABILIFY MAINTENA?
- ABILIFY MAINTENA is an injection given in your buttock by your healthcare provider 1 time a month. You may feel a little pain in your buttock during your injection.
- After your first injection of ABILIFY MAINTENA you should continue your current antipsychotic medicine for 2 weeks.
- You should not miss a dose of ABILIFY MAINTENA. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.
What should I avoid while receiving ABILIFY MAINTENA?
- Do not drive, operate machinery, or do other dangerous activities until you know how ABILIFY MAINTENA affects you. ABILIFY MAINTENA may make you feel drowsy.
- Do not drink alcohol while you receive ABILIFY MAINTENA.
- Do not become too hot or dehydrated while you receive
- Do not exercise too much.
- In hot weather, stay inside in a cool place if possible.
- Stay out of the sun.
- Do not wear too much clothing or heavy clothing.
- Drink plenty of water.
What are the possible side effects of ABILIFY MAINTENA?
ABILIFY MAINTENA may cause serious side effects, including:
- See “What is the most important information I should know about ABILIFY MAINTENA?”
- Uncontrolled body movements (tardive dyskinesia). ABILIFY MAINTENA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop receiving ABILIFY MAINTENA. Tardive dyskinesia may also start after you stop receiving ABILIFY MAINTENA.
- Problems with your metabolism such as:
- High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take ABILIFY MAINTENA. Extremely high blood sugar can lead to coma or death. If you have diabetes or risk factors for diabetes (such as being overweight or a family history of diabetes), your healthcare provider should check your blood sugar before you start receiving ABILIFY MAINTENA and during your treatment.
Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving ABILIFY MAINTENA:
- feel very thirsty
- need to urinate more than usual
- feel very hungry
- feel weak or tired
- feel sick to your stomach
- feel confused, or your breath smells fruity
- Increased fat levels (cholesterol and triglycerides) in your blood.
- Weight gain. You and your healthcare provider should check your weight regularly.
- Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
- Low white blood cell count
- Seizures (convulsions)
- Problems controlling your body temperature so that you feel too warm. See “What should I avoid while receiving ABILIFY MAINTENA?”
- Difficulty swallowing
The most common side effect of ABILIFY MAINTENA includes feeling like you need to move to stop unpleasant feelings in your legs (restless leg syndrome or akathisia).
Tell your healthcare provider if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of ABILIFY MAINTENA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of ABILIFY MAINTENA
This Medication Guide summarizes the most important information about ABILIFY MAINTENA. If you would like more information, talk with your healthcare provider.
You can ask your healthcare provider or pharmacist for information about ABILIFY MAINTENA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ABILIFY MAINTENA that is written for healthcare professionals.
For more information about ABILIFY MAINTENA, go to www.ABILIFYMAINTENA.com or call 1-800-441-6763.
What are the ingredients in ABILIFY MAINTENA?
Active ingredient: aripiprazole monohydrate
Inactive ingredients: carboxymethyl cellulose sodium, mannitol, sodium phosphate monobasic monohydrate and sodium hydroxide
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 12/12/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Abilify Maintena Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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