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About VIVITROL
What is VIVITROL


How does VIVITROL work?


How may VIVITROL help me?


How safe is VIVITROL?


Real Stories of Recovery


Important safety information



What is VIVITROL


How VIVITROL works


What to expect from treatment
Who should not take VIVITROL?1

Do not take VIVITROL if you:

  • are using and/or have a physical dependence on opioid-containing medicines or opioid street drugs.
    • You must not take opioid-containing medicines or opioid street drugs for 7-10 days before you start taking VIVITROL. (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 doctor may give you a small injection of a medicine called naloxone. This is called a naloxone challenge test. If you develop symptoms of opioid withdrawal after the naloxone challenge test, you should not start treatment with VIVITROL at that time. Your doctor may repeat the test after you have stopped using opioids to see whether it is safe to start VIVITROL.

  • have opioid withdrawal symptoms.
    • Opioid withdrawal symptoms may occur when you have been taking opioid-containing medicines or opioid street drugs regularly and then stop. These symptoms 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?”)

  • are allergic to VIVITROL or any of the ingredients in the liquid used to mix VIVITROL (diluent). See the end of this leaflet for a complete list of ingredients in VIVITROL and the diluent.

 

 

 

 

 

 

 

 

 

 

 

If you would like more information on alcohol dependence and treatment options, please talk with your doctor or healthcare provider.
 

Important Patient Safety Information

VIVITROL is a prescription injectable medicine used to treat alcohol dependence in adults 18 years and older. You should stop drinking before starting VIVITROL. To be effective, treatment must be used along with other alcoholism recovery programs such as counseling. Do not take VIVITROL if you are using and/or have a physical dependence on opioid-containing medicines, such as prescription pain pills, or opioid street drugs, such as heroin, or if you have opioid withdrawal symptoms. You must not take opioid-containing medicines or opioid street drugs for 7-10 days before you start taking VIVITROL.

Some people on VIVITROL treatment have had severe reactions at the site of the injection (injection site reactions) including tissue death (necrosis) and some have required surgery. Call your doctor right away if you have any of the following things happen at any of your injection sites: intense pain, the area
feels hard, large area of swelling, lumps, blisters, an open wound or a dark scab.

The active ingredient in VIVITROL (naltrexone) has been associated with liver damage (including liver failure) or hepatitis when given in amounts greater than the recommended dose. Tell your doctor if you have any of the following symptoms: stomach area pain lasting more than a few days, dark urine, yellowing of the whites of your eyes or tiredness.

VIVITROL can cause other serious side effects such as depressed mood that sometimes can lead to suicide, suicidal thoughts and suicidal behavior. You should tell your family members if you are taking VIVITROL. Call your doctor right away if you experience signs of depression.

VIVITROL blocks the effects of opioid-containing medicines and opioid street drugs; you may not feel the effects of opioid-containing medicines and opioid street drugs while taking VIVITROL. Do not take large amounts of opioids, including opioid-containing medicines or heroin, to overcome effects of VIVITROL. This can lead to overdose including serious injury, coma or death. If you have used opioidcontaining medicines or opioid street drugs in the past, you may be more sensitive to lower doses of opioids after VIVITROL treatment stops. This can lead to overdose.

Some people on VIVITROL treatment have had severe allergic pneumonia. Call your doctor immediately if you have shortness of breath, coughing or wheezing. Common side effects of VIVITROL include; Nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints and muscle cramps.

Please see attached full Medication Guide.

 
Alkermes