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Important safety information



What is VIVITROL


How VIVITROL works


What to expect from treatment
What are the possible side effects of VIVITROL?1

VIVITROL can cause serious side effects. (See What is the most important information I should know about VIVITROL?)

Other serious side effects include: depressed mood, sometimes leading to suicide, suicidal thoughts, and suicidal behavior. Tell your family members that you are taking VIVITROL.

You or a family member should call your doctor right away if you become depressed or have any of the following symptoms of depression, especially if they are new, worse, or worry you:

  • You feel sad or have crying spells.
  • You are no longer interested in seeing your friends or doing things you used to enjoy.
  • You are sleeping a lot more or a lot lessthan usual.
  • You feel hopeless or helpless.
  • You are more irritable, angry or aggressive than usual.
  • You are more or less hungry than usual or notice a big change in your body weight.
  • You have trouble paying attention.
  • You feel tired or sleepy all the time.
  • You have thoughts about hurting yourself or ending your life.

Common side effects of VIVITROL include:

  • nausea. Nausea usually improves within a few days after the first VIVITROL injection. Nausea is less likely with future injections of VIVITROL.
  • tiredness
  • headache
  • dizziness
  • vomiting
  • decreased appetite
  • painful joints
  • muscle cramps

Tell your doctor about 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 doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
 

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.

 
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