Abilify Maintena Warnings and Precautions

To help avoid complications like strokes or dangerous infections, make sure to discuss the warnings and precautions for Abilify Maintena with your healthcare provider. People who have a history of problems with their heart, blood pressure, or white blood cell counts may not be able to use this medication. Safety concerns also apply to people with certain allergies and those taking certain medications.


What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to receiving Abilify Maintena™ (aripiprazole ER injection) if you have:
In addition, let your healthcare provider know if you are:
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings for Abilify Maintena

Some warnings and precautions to be aware of prior to receiving Abilify Maintena include the following:
  • Antipsychotic medications such as Abilify Maintena have been associated with an increased risk for strokes and death when used to treat behavioral and mental health problems caused by dementia. Some reported deaths were due to strokes and infections. The potential benefits of using such drugs in people with dementia must be carefully weighed against the risks. No antipsychotic is approved to treat the behavioral symptoms of dementia.
  • Like other antipsychotic medications, Abilify Maintena may cause a rare, but life-threatening problem known as neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop signs of NMS, which may include:
    • A high fever or sweating
    • Confusion
    • Muscle stiffness
    • A fast or irregular heartbeat.
  • Antipsychotic medications can cause a potentially irreversible movement disorder known as tardive dyskinesia. Tardive dyskinesia involves uncontrollable facial, tongue, or body movements. The risk increases with age and increasing dose and duration of antipsychotic use; however, it can happen in anyone and at any dose. There is no well-established treatment for this condition. Tell your healthcare provider if you experience any abnormal movements during Abilify Maintena treatment.
  • Abilify Maintena may cause high blood glucose (blood sugar levels), high lipids, and weight gain. These side effects can increase your risk for other problems, including heart disease and strokes. Your healthcare provider will monitor your blood sugar, cholesterol, and weight during treatment. You may need to take other medicines to help control these problems if they occur.
  • Some people who use Abilify Maintena may experience dizziness and lightheadedness, especially when rising from a seated or lying-down position. Dehydration, which can happen if you don't drink enough fluids or have extreme diarrhea or vomiting, can make this effect worse. Try to stay hydrated while using this medicine. Also, sit or stand slowly to help minimize this side effect.
  • Abilify Maintena may decrease white blood cell counts, which could increase your risk for developing an infection. If you already have low white blood cell counts, your healthcare provider will monitor this frequently during the first few months of treatment. Tell your healthcare provider if you develop signs of an infection, such as:
  • This medication can make you drowsy and dizzy, which could affect your thinking, judgment, and motor skills. Do not perform any activities that require mental alertness, such as driving, until you know how Abilify Maintena affects you. Also, avoid drinking alcohol during treatment, as alcohol can make these effects worse.
  • There were rare reports of seizures occurring in clinical trials of Abilify Maintena. Make sure your healthcare provider knows if you have a history of seizures before you receive this medicine.
  • Abilify Maintena may cause difficulty swallowing, which could cause you to inhale food (known as aspiration). Aspiration may increase the risk for pneumonia in certain people, especially older adults with advanced dementia.
  • People who take this medication may become overheated more easily when exercising or exposed to high temperatures. Being dehydrated can make this effect more severe. Take care to stay hydrated and to avoid becoming overheated during treatment.
  • This medication passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Abilify Maintena and Breastfeeding).
  • Abilify Maintena is a pregnancy Category C medication. This means that it may not be safe for use during pregnancy, although the full risks are currently unknown (see Abilify Maintena and Pregnancy).
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