VIVITROL - naltrexone 
Alkermes, Inc.

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MEDICATION GUIDE

VIVITROL ®(viv-i-trol)

(naltrexone for extended-release injectable suspension)

Read this Medication Guide before you start receiving VIVITROL injections and each time you receive an 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 VIVITROL?

VIVITROL can cause serious side effects, including:

  1. Risk of opioid overdose.
    You can accidentally overdose in two ways.
    • VIVITROL blocks the effects of opioids, such as heroin or opioid pain medicines. Do not take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of VIVITROL. This can lead to serious injury, coma, or death.
    • After you receive a dose of VIVITROL, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with VIVITROL can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
      • after you have gone through detoxification
      • when your next VIVITROL dose is due
      • if you miss a dose of VIVITROL
      • after you stop VIVITROL treatment

      It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

    You or someone close to you should get emergency medical help right away if you:

    • have trouble breathing
    • become very drowsy with slowed breathing
    • have slow, shallow breathing (little chest movement with breathing)
    • feel faint, very dizzy, confused, or have unusual symptoms
  2. Severe reactions at the site of the injection (injection site reactions). Some people on VIVITROL have had severe injection site reactions, including tissue death (necrosis). Some of these injection site reactions have required surgery. VIVITROL must be injected by a healthcare provider. Call your healthcare provider right away if you notice any of the following at any of your injection sites:
    • intense pain
    • the area feels hard
    • large area of swelling
    • lumps
    • blisters
    • an open wound
    • a dark scab
    Tell your healthcare provider about any reaction at an injection site that concerns you, gets worse over time, or does not get better by two weeks after the injection.
  3. Sudden opioid withdrawal.
    Anyone who receives a VIVITROL injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. Using opioids in the 7 to 14 days before you start receiving VIVITROL may cause you to suddenly have symptoms of opioid withdrawal when you get the VIVITROL injection. Sudden opioid withdrawal can be severe and you may need to go to the hospital.
    You must be opioid-free before receiving VIVITROL unless your healthcare provider decides that you don't need to go through detox first. Instead, your doctor may decide to give your VIVITROL injection in a medical facility that can treat you for sudden opioid withdrawal.
  4. Liver damage or hepatitis. Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis.
    Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with VIVITROL:
    • stomach area pain lasting more than a few days
    • dark urine
    • yellowing of the whites of your eyes
    • tiredness

    Your healthcare provider may need to stop treating you with VIVITROL if you get signs or symptoms of a serious liver problem.

What is VIVITROL?

VIVITROL is a prescription injectable medicine used to:

To be effective, treatment with VIVITROL must be used with other alcohol or drug recovery programs such as counseling. VIVITROL may not work for everyone.

It is not known if VIVITROL is safe and effective in children.

Who should not receive VIVITROL?

Do not receive VIVITROL if you:

What should I tell my healthcare provider before receiving VIVITROL?

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

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

Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea. See “What is the most important information I should know about VIVITROL?

If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or opioid street drugs, it is important that you tell your healthcare provider before starting VIVITROL to avoid having sudden opioid withdrawal symptoms when you start VIVITROL treatment.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How will I receive VIVITROL?

What should I avoid while receiving VIVITROL?

Do not drive a car, operate machinery, or do other dangerous activities until you know how VIVITROL affects you. VIVITROL may make you feel dizzy and sleepy. See “What are the possible side effects of VIVITROL?

What are the possible side effects of VIVITROL?

VIVITROL can cause serious side effects, including:

Common side effects of VIVITROL may include:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the side effects of VIVITROL. 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 VIVITROL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about VIVITROL. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about VIVITROL that is written for health professionals.

For more information about VIVITROL call 1-800-848-4876, Option #1 or go to www.vivitrol.com.

What are the ingredients in VIVITROL?

Active ingredient: naltrexone

Inactive ingredients: polylactide-co-glycolide (PLG)

Diluent ingredients: carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water for injection

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured and marketed by:
Alkermes, Inc.
852 Winter Street
Waltham, MA 02451-1420
Revised: July 2019
Alkermes® and VIVITROL® are registered trademarks of Alkermes, Inc.

Revised: 9/2019
Alkermes, Inc.