How safe is VIVITROL?

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How safe is VIVITROL?

VIVITROL has been shown to be generally well tolerated with most side effects rated as mild to moderate.14

VIVITROL is not addictive.

However, some patients may experience side effects with VIVITROL, including some serious side effects. Please refer to the information on potential side effects and talk to your doctor or healthcare provider.

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.