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Call your doctor for medical advice about side effects. You are encouraged to report
negative side effects to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
VIVITROL® (naltrexone for extended-release suspension) is a prescription injectable medicine used to treat alcohol dependence, and to prevent relapse to opioid dependence, after opioid detoxification. You should stop drinking before starting VIVITROL. To be effective, treatment with VIVITROL must be used along with other alcoholism or drug recovery programs such as counseling. VIVITROL may not work for everyone. VIVITROL has not been studied in children under the age of 18 years.
Do not take VIVITROL if you are using or have physical dependence on opioid street drugs, such as heroin, or opioid-containing medicine, such as prescription pain medicine. You must not take opioid-containing medicines or opioid street drugs for 7-10 days before you start taking VIVITROL. You should not take VIVITROL if you have opioid withdrawal symptoms or are allergic to VIVITROL or any of the ingredients in the liquid used to mix VIVITROL (diluent). Click here to read the full medication guide to find out more about opioid withdrawal symptoms and to see a complete list of ingredients in VIVITROL and the diluent.
SEVERE REACTIONS AT THE SITE OF INJECTION
Some people on VIVITROL treatment have had severe reactions at the site of injection (injection site reactions), including tissue death (necrosis). Some of these injection site reactions have required surgery. Call your doctor right away if you have any of the following things happen at your injection site: intense pain, the area feels hard, large area of swelling, lumps, blisters, an open wound or dark scab.
LIVER DAMAGE OR HEPATITIS
Naltrexone, the active ingredient in VIVITROL, can cause liver damage (including liver failure) or hepatitis, if you take more than the recommended dose. Tell your doctor 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, or tiredness. Your doctor may need to stop treating you with VIVITROL if you get signs or symptoms of a serious problem.
RISK OF OPIOID OVERDOSE
If you have used opioid-containing medicines or opioid street drugs in the past, you may be more sensitive to lower doses of opioids after VIVITROL treatment stops, when your next VIVITROL dose is due or if you miss a dose of VIVITROL. Using opioids in amounts you used before treatment with VIVITROL can lead to overdose and death. You may not feel the usual effects if you use or abuse heroin and other illegal (street) drugs while on VIVITROL. Do not take large amounts of opioids, including opioid-containing medicines, such as prescription pain pills, or heroin, to overcome effects of VIVITROL. This can lead to overdose including serious injury, coma, or death. You may not feel the usual effects of opioid-containing medicines including medicines for pain, cough and diarrhea while on VIVITROL. 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, or have unusual symptoms.
SEVERE ALLERGIC PNEUMONIA
Some people on VIVITROL treatment have had severe allergic pneumonia. Call your doctor right away if you experience shortness of breath or coughing that does not go away. You may need to go to the hospital for treatment with antibiotic and steroid medicines.
SERIOUS ALLERGIC REACTIONS
Serious allergic reactions can happen during or soon after an injection of VIVITROL. Tell your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction: skin rash, swelling of your face, mouth or tongue, trouble breathing or wheezing, chest pain, feeling dizzy or faint.
VIVITROL can cause other serious side effects, such as depressed mood that can sometimes lead to suicide, suicidal thoughts and suicidal behavior. You should tell your family members and the people closest to you if you are taking VIVITROL. Call your doctor right away if you experience signs of depression. Click here to find out more about some symptoms of depression.
Common side effects of VIVITROL include nausea, tiredness, headache, vomiting, decreased appetite, painful joints and muscle cramps. In addition, common side effects in people taking VIVITROL for opioid dependence also include cold symptoms, trouble sleeping, and toothache.
Call your doctor for medical advice about side effects. You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call