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VIVITROL ® (naltrexone for extended-release injectable suspension) is an opioid antagonist with little, if any, opioid agonist activity. It is used in the treatment of alcohol and opioid addiction and dependence. It works by blocking the euphoria associated with opioid use and alcohol intoxication. Its major benefit is that it needs only to be administered once a month.

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 opioidcontaining 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. Call your healthcare provider right away if you notice any of the following at any of your injection sites:

  • intense pain
  • blisters
  • the area feels hard
  • an open wound
  • large area of swelling
  • a dark scab
  • lumps

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 the7 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.

Who should not receive VIVITROL?

Do not receive VIVITROL if you:

  • are using or have a physical dependence on opioid-containing medicines or opioid street drugs. See “What is the most important information I should know about VIVITROL?”

To see whether you have a physical dependence on opioid-containing medicines or opioid street drugs, your healthcare provider may give you a small injection of a medicine called naloxone. This is called a naloxone challenge test.

If you get symptoms of opioid withdrawal after the naloxone challenge test, do not start treatment with VIVITROL at that time.

    Your healthcare provider may repeat the test after you have stopped using opioids to see whether it is safe to start VIVITROL.

  • are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid-containing medicines or opioid street drugs regularly and then stop.

Symptoms of opioid withdrawal may include:

    anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goose bumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.

See “What is the most important information I should know about VIVITROL?”
Tell your healthcare provider if you have any of these symptoms before taking VIVITROL.
are allergic to naltrexone or any of the ingredients in VIVITROL or the liquid used to mix VIVITROL (diluent). See the end of this Medication Guide for a complete list of ingredients in VIVITROL and the diluent.

What should I tell my healthcare provider before receiving VIVITROL?
Before you receive VIVITROL, tell your healthcare provider if you:

  • have liver problems
  • use or abuse street (illegal) drugs
  • have hemophilia or other bleeding problems
  • have kidney problems
  • have any other medical conditions
  • are pregnant or plan to become pregnant. It is not known if VIVITROL will harm your unborn baby.
  • are breastfeeding. It is not known if VIVITROL passes into your milk, and if it can harm your baby. Naltrexone, the active ingredient in VIVITROL, is the same active ingredient in tablets taken by mouth that contain naltrexone. Naltrexone from tablets passes into breast milk. Talk to your healthcare provider about whether you will breastfeed or take VIVITROL. You should not do both.

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.

Information provided above is courtesy of: https://www.fda.gov

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