FDA Approves Aristada

Aristada

Generic Name: aripiprazole lauroxil
Date of Approval: October 5, 2015
Company: Alkermes, Inc.

Aristada is the first atypical antipsychotic with once-monthly and six-weekly dosing options.

The U.S. Food and Drug Administration (FDA) has approved Aristada (aripiprazole lauroxil), an extended-release injectable atypical antipsychotic for the treatment of patients with schizophrenia.

MEDICATION GUIDE

Read this Medication Guide before you start treatment and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor.

IMPORTANT INFORMATION ABOUT ARISTADA

Each injection of Aristada must be administered by a healthcare professional only.

Aristada may cause serious side effects, including:

• Increased risk of death in elderly people with dementia-related psychosis. Aristada 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
  • Confusion
  • Sweating
  • Changes in pulse, heart rate, and blood pressure

Call your healthcare provider right away if you have any of these symptoms.

WHAT IS ARISTADA?

Aristada is a prescription medicine given by injection by a healthcare professional and used to treat schizophrenia. It is not known if it is safe and effective in children under 18 years of age.

WHO SHOULD NOT RECEIVE ARISTADA?

Do not receive Aristada if you are allergic to aripiprazole or any of the other ingredients. See the end of this page for a complete list of active and inactive ingredients.

BEFORE RECEIVING ARISTADA

Before you receive Aristada, tell your healthcare provider if you:

• have never taken Abilify, Abilify Maintena or any aripiprazole product previously
• 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 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 or your arm
• are pregnant or plan to become pregnant. It is not known if Aristada will harm your unborn baby.
  • If you become pregnant while taking Aristada, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/
• are breastfeeding or plan to breastfeed. Aristada can pass into your milk and it is not known if it may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment.

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

Aristada and other medicines may affect each other causing possible serious side effects. Aristada may affect the way other medicines work, and vice versa. Your healthcare provider can tell you if it is safe to take Aristada with your other medicines. Do not start or stop any medicines during treatment without talk ing 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 ARISTADA?

• Follow your treatment schedule exactly as your healthcare provider tells you to.
• Each dose is given as an injection in your arm or buttock by your healthcare provider once a month or once every six weeks. You may feel a little pain inyour arm or buttock during the injection.
• After your first injection, you should continue your current antipsychotic medicine for 21 days.
• Do not miss a dose. If you do 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 Aristada?

• Do not drive a car, operate machinery, or do other dangerous activities until you know how the treatment affects you. It may make you feel drowsy.
• Do not drink alcohol during treatment.
• Do not become too hot or dehydrated during treatment.
  • 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 SIDE EFFECTS

Aristada may cause serious side effects, including:

• See Important information about Aristada
• Stroke in elderly people (cardiovascular problems) that can lead to death
• Neuroleptic malignant syndrome (NMS): Tell your healthcare provider right away if you have some or all of the following symptoms: high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure. These may be symptoms of a rare and serious condition that can lead to death. Call your healthcare provider right away if you have any of these symptoms.
• Uncontrolled body movements (tardive dyskinesia): movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop treatment. Tardive dyskinesia may also start after you stop treatment.
• Problems with your metabolism such as:
  • High blood sugar (hyperglycemia): Increases in blood sugar can happen in some people who take 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 start, and during your treatment.Call your healthcare provider if you have any of these symptoms of high blood sugar while receiving Aristada:
    • 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. 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 Aristada?
• Difficulty swallowing

The most common side effects include 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 that does not go away.

These are not all the possible side effects. 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 ARISTADA

This Medication Guide summarizes the most important information. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for health professionals.

WHAT ARE THE INGREDIENTS IN ARISTADA?

Active ingredient: aripiprazole lauroxil

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