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FAQs

Here are answers to questions you may have about ARISTADA INITIO and ARISTADA

ARISTADA INITIO™ (aripiprazole lauroxil) and ARISTADA® (aripiprazole lauroxil) may cause serious side effects, including: Increased risk of death in elderly people with dementia-related psychosis. ARISTADA INITIO and ARISTADA increase the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ARISTADA INITIO and ARISTADA are not for the treatment of people with dementia-related psychosis.

ARISTADA INITIO is a prescription medicine given as a one-time injection and is used in combination with oral aripiprazole to start ARISTADA treatment, or re-start ARISTADA treatment after a missed dose, when ARISTADA is used for the treatment of schizophrenia in adults.

It is not known if ARISTADA INITIO is safe and effective in children.

ARISTADA is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia.

It is not known if ARISTADA is safe and effective in children under 18 years of age.

Do not receive ARISTADA INITIO or ARISTADA if you are allergic to aripiprazole or any of the ingredients in ARISTADA INITIO and ARISTADA.

See the Medication Guides for ARISTADA INITIO and ARISTADA for a complete list of ingredients.

Tell your healthcare provider about all of your medical conditions, including if you:

  • have not taken ABILIFY®, ABILIFY MAINTENA® or any aripiprazole product before
  • have or had heart problems or a stroke
  • 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 ARISTADA INITIO and ARISTADA and during your treatment.
  • have or had low or high blood pressure
  • have or had seizures (convulsions)
  • have or had a low white blood cell count
  • have problems that may affect you receiving an injection in your buttocks or your arm
  • are pregnant or plan to become pregnant. It is not known if ARISTADA INITIO or ARISTADA will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. ARISTADA INITIO and ARISTADA can pass into your breast milk and it is not known if they may harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive ARISTADA INITIO and ARISTADA.

Yes. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

ARISTADA INITIO, ARISTADA, and other medicines may affect each other causing possible serious side effects. ARISTADA INITIO and ARISTADA may affect the way other medicines work, and other medicines may affect how ARISTADA INITIO and ARISTADA work.

Your healthcare provider can tell you if it is safe to receive ARISTADA INITIO and ARISTADA with your other medicines. Do not start or stop any medicines while receiving ARISTADA INITIO and ARISTADA without talking to your healthcare provider first.

  • Follow your ARISTADA INITIO treatment schedule exactly as your healthcare provider tells you to.
  • ARISTADA INITIO is a one-time injection given by your healthcare provider, into the muscle (intramuscular) of your arm or buttock.
  • ARISTADA INITIO is given in combination with a single dose of oral aripiprazole. You may also receive your first injection of ARISTADA on the same day you receive ARISTADA INITIO or up to 10 days after you receive ARISTADA INITIO.
  • ARISTADA INITIO should only be used as a one-time dose to start ARISTADA treatment or to re-start ARISTADA treatment after a missed dose. ARISTADA INITIO is not meant for repeated dosing.
  • Follow your ARISTADA treatment schedule exactly as your healthcare provider tells you to.
  • Each ARISTADA is an injection given in your arm or buttock by your healthcare provider. You may feel a little pain in your arm or buttock during the injection.
  • When starting ARISTADA, you will receive a single 30 mg dose of oral aripiprazole, a one-time injection of ARISTADA INITIO and your first injection of ARISTADA which can be given on the same day or up to 10 days later. Your doctor may determine that ARISTADA INITIO is not right for you. In this case, you will need to take oral aripiprazole for 21 days in a row with your first ARISTADA injection.
  • You should not miss a dose of ARISTADA. If you miss a dose for some reason, call your healthcare provider right away to discuss what you should do next.
  • Do not drive a car, operate machinery, or do other dangerous activities until you know how ARISTADA INITIO and ARISTADA affect you. ARISTADA INITIO and ARISTADA may affect your judgment, thinking or motor skills.
  • Do not become too hot or dehydrated while you receive ARISTADA INITIO and ARISTADA.
    • 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.

ARISTADA INITIO and ARISTADA may cause serious side effects, including:

  • See “What is the most important information I should know about ARISTADA INITIO and ARISTADA?”
  • Cerebrovascular problems (including stroke) in elderly people with dementia-related psychosis that can lead to death
  • Neuroleptic malignant syndrome (NMS), a serious condition that can lead to death. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:
    • high fever
    • stiff muscles
    • confusion
    • sweating
    • changes in pulse, heart rate, and blood pressure
  • Uncontrolled body movements (tardive dyskinesia). ARISTADA INITIO and ARISTADA may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away.
  • Problems with your metabolism such as:
    • high blood sugar (hyperglycemia). Increases in blood sugar can happen in some people who receive ARISTADA INITIO and/or ARISTADA. 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 receive ARISTADA INITIO and/or ARISTADA and during your treatment with ARISTADA.


      Call your healthcare provider if you have any of these symptoms of high blood sugar:

      • Feel very thirsty
      • Feel very hungry
      • Feel sick to your stomach
      • Need to urinate more than usual
      • Feel weak or tired
      • Feel confused, or your breath smells fruity
    • increased fat levels (cholesterol and triglycerides) in your blood.
    • weight gain.
  • Unusual and uncontrollable (compulsive) urges. Some people taking aripiprazole have had strong unusual urges to gamble and gambling that cannot be controlled (compulsive gambling). Other compulsive urges include sexual urges, shopping, and eating or binge eating. If you or your family members notice that you are having unusual strong urges, talk to your healthcare provider.
  • Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
  • Falls. ARISTADA INITIO and ARISTADA may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position and can slow your thinking and motor skills which may lead to falls that can cause fractures or other injuries.
  • Low white blood cell count
  • Seizures (convulsions)
  • Problems controlling your body temperature. See “What should I avoid while receiving ARISTADA INITIO and ARISTADA?”
  • Difficulty swallowing

The most common side effects of ARISTADA INITIO and ARISTADA include restlessness or feeling like you need to move (akathisia).

These are not all the possible side effects of ARISTADA INITIO and ARISTADA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Active ingredient: aripiprazole lauroxil

Inactive ingredients: polysorbate 20, sodium chloride, sodium citrate dihydrate, sodium phosphate dibasic anhydrous, sodium phosphate monobasic and water for injection

Active ingredient: aripiprazole lauroxil

Inactive ingredients: sorbitan monolaurate, polysorbate 20, sodium chloride, sodium phosphate dibasic anhydrous, sodium phosphate monobasic and water for injection

If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ARISTADA INITIO and ARISTADA that is written for health professionals.

Each injection of ARISTADA INITIO and ARISTADA must be administered by a healthcare professional only.

Curious about how ARISTADA can help?

SEE WHAT TO EXPECT