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, such as heroin. To test for a physical dependence on opioid-containing medicines or 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 flashes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.
  • are allergic to naltrexone or any of the ingredients in VIVITROL or the liquid used to mix VIVITROL (diluent). See the medication guide for the full list of ingredients.

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, or 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.

What are other possible serious side effects of VIVITROL?

VIVITROL can cause serious side effects, including:

  • Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking VIVITROL.
  • Pneumonia. Some people receiving VIVITROL treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.

Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of VIVITROL. Tell your healthcare provider or get medical help right away if you have any of these symptoms:

  • skin rash
  • trouble breathing or wheezing
  • feeling dizzy or faint
  • swelling of your face, eyes, mouth, or tongue
  • chest pain

Common side effects of VIVITROL may include:

  • nausea. Nausea may happen after your first VIVITROL injection and usually improves within a few days. Nausea is less likely with future injections of VIVITROL.
  • sleepiness
  • headache
  • dizziness
  • vomiting
  • decreased appetite
  • painful joints
  • muscle cramps
  • cold symptoms
  • toothache
  • trouble sleeping

These are not all the side effects of VIVITROL. Tell your healthcare provider if you have any side effect that bothers you or that do not go away.You may report side effects to the FDA at 1-800- FDA-1088. This is only a summary of the most important information about VIVITROL. This information is based on the VIVITROL Medication Guide (Rev. July 2013).