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References
  1. VIVITROL Patient Information [Medication Guide]. Waltham, MA: Alkermes, Inc.; March 2010
  2. Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, Pickering RP. The 12-month prevalence and trends in DSM-IV alcohol abuse and dependence: United States, 1991-1992 and 2001-2002. Drug Alcohol Depend. 2004;74:223-234.
  3. US Department of Health and Human Services. 10th Special Report to the US Congress on Alcohol and Health. 2000. http://pubs.niaaa.nih.gov/publications/10report/intro.pdf.
  4. Anton RF. Naltrexone for the management of alcohol dependence. N Engl J Med. 2008;359:715-721.
  5. Myrick H, Anton RF, Li X, Henderson S, Randall PK, Voronin K. Effect of naltrexone and ondansetron on alcohol cue–induced activation of the ventral striatum in alcohol-dependent people. Arch Gen Psychiatry. 2008;65:466-475.
  6. Ewing JA. Detecting alcoholism: the CAGE questionnaire. JAMA.1984;252:1905-1907.
  7. Sher KJ, Grekin ER, Williams NA. The development of alcohol use disorders. Annu Rev Clin Psychol. 2005;1:493-523.
  8. Grant BF. The impact of a family history of alcoholism on the relationship between age at onset of alcohol use and DSM–IV alcohol dependence: results of the National Longitudinal Alcohol Epidemiologic Survey. Alcohol Health Res World. 1998;22:144-147.
  9. Hasin DS, Stinson FS, Ogburn E, Grant BF. Prevalence, correlates, disability, and comorbidity of DSM-IV alcohol abuse and dependence in the United States. Arch Gen Psychiatry. 2007;64:830-842.
  10. National Institute on Alcohol Abuse and Alcoholism. Helping patients who drink too much: a clinician's guide. NIH publication 07-3769. http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide2005/guide.pdf. May 2007 reprint. Accessed July 24, 2008.
  11. Substance Abuse and Mental Health Services Administration, Division of Pharmacologic Therapies. Medication-assisted treatment for substance use disorders. http://www.dpt.samhsa.gov. Accessed May 5, 2008.
  12. Fishman MJ, DiClemente CC, Levounis P, McLellan AT, Mee-Lee D. CME activity based on: Achieving treatment success in alcohol dependence: integrating pharmacologic and psychosocial approaches. American Society of Addiction Medicine (ASAM) 2007 Annual Medical Scientific Conference; April 28, 2007; Miami, FL.
  13. US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration, Center for Substance Abuse Treatment. Substance Abuse Treatment Advisory. 2007;6(1). http://download.ncadi.samhsa.gov/prevline/pdfs/SMA07-4267.pdf.
  14. VIVITROL [full prescribing information]. Cambridge, MA: Alkermes, Inc; December 2008.
  15. Oswald LM, Wand GS. Opioids and alcoholism. Physiol Behav. 2004;81:339-358.
  16. Kenna GA, McGeary JE, Swift RM. Pharmacotherapy, pharmacogenomics, and the future of alcohol dependence treatment, part 1. Am J Health Syst Pharm. 2004;61:2272-2279.
  17. Data on file, Alkermes, Inc.

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.

 
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