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References
  1. VIVITROL [Full Prescribing Information]. Cambridge, MA: Alkermes, Inc; June 2009.
  2. 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.
  3. O’Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007;27(5):507-512.
  4. Ciraulo DA, Dong Q, Silverman BL, Gastfriend DR, Pettinati HM. Early treatment response in alcohol dependence with extended-release naltrexone. J Clin Psychiatry. 2008;69(2):190-195.
  5. Grant BF, Dawson DA. Introduction to the National Epidemiologic Survey on Alcohol and Related Conditions. Alcohol Res Health. 2006;29(2):74-78.
  6. Mokdad AH, Marks JS, Stroup DF, Gerberding JL. Actual causes of death in the United States, 2000. JAMA. 2004;291(10):1238-1245.
  7. Swift RM. The pharmacotherapy of alcohol dependence: clinical and economic aspects. Economics of Neuroscience. 2001;3(12):62-66.
  8. Witbeck G, Hornfeld S, Dalack GW. Emergency room outreach to chronically addicted individuals: a pilot study. J Subst Abuse Treat. 2000;19:39-43.
  9. Harwood H. Updating Estimates of the Economic Costs of Alcohol Abuse in the United States: Estimates, Update Methods, and Data. [Based on data in Harwood et al., 1998.] Report prepared by The Lewin Group for the National Institute on Alcohol Abuse and Alcoholism, 2000.
  10. The George Washington University Medical Center. Ensuring solutions to alcohol problems. Primer 1: treating alcoholism as a chronic disease. http://www.ensuringsolutions.org/usr_doc/PDF_Version_of_Primer.pdf. Accessed June 18, 2008.
  11. Saitz R. Clinical practice. Unhealthy alcohol use. N Engl J Med. 2005;352(6):596-607.
  12. American Medical Association. Alcohol and other drug abuse. http://www.ama-assn.org/ama/pub/category/3337.html. Accessed July 5, 2008.
  13. American Psychiatric Association. Practice Guideline for the Treatment of Patients With Substance Use Disorders. 2nd ed. American Psychiatric Publishing, Inc; 2008. http://www.psychiatryonline.com/popup.aspx?aID=149092. Accessed April 30, 2008.
  14. The National Council on Alcoholism and Drug Dependence. Interviews with the experts: Robert Morse, MD on the use of pharmacology in addiction treatment. http://www.ncadd.org/facts/morse.html. Accessed May 5, 2008.
  15. 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.
  16. National Institute on Alcohol Abuse and Alcoholism. Helping patients who drink too much: a clinician’s guide. http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide2005/guide.pdf. May 2007 reprint. Accessed May 5, 2008.
  17. Gianoulakis C. Alcohol-seeking behavior: the roles of the hypothalamic-pituitary-adrenal axis and the endogenous opioid system. Alcohol Health Res World. 1998;22(3):202-210.
  18. Woodward JJ. The pharmacology of alcohol. In: Graham AW, Schultz TK, Mayo-Smith MF, Ries RK, Wilford BB, eds. Principles of Addiction Medicine. 3rd ed. Chevy Chase, MD: The American Society of Addiction Medicine, Inc; 2003:101-118.
  19. Oswald LM, Wand GS. Opioids and alcoholism. Physiol Behav. 2004;81:339-358.
  20. 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.
  21. Data on file. Alkermes, Inc.
  22. Drug and Alcohol Services Information System. The DASIS report: discharges from detoxification: 2000. http://oas.samhsa.gov/2K4/detoxDischarges/detoxDischarges.pdf. Published July 9, 2004. Accessed January 23, 2008.
  23. Dunbar JL, Turncliff RZ, Dong Q, Silverman BL, Ehrich EW, Lasseter KC. Single- and multiple-dose pharmacokinetics of long-acting injectable naltrexone. Alcohol Clin Exp Res. 2006;30(3):480-490.
 
INDICATION1

VIVITROL® is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.

Patients should not be actively drinking at the time of initial VIVITROL administration.

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.
 
IMPORTANT SAFETY INFORMATION FOR VIVITROL1

VIVITROL is contraindicated in patients receiving opioid analgesics or with current physiologic opioid dependence, patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, or in patients who have previously exhibited hypersensitivity to naltrexone PLG, carboxymethylcellulose or any other components of the diluent.

VIVITROL patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in a fatal overdose because patients may be more sensitive to lower doses of opioids. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation.


Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

VIVITROL is administered as a gluteal intramuscular injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using the customized needle provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for intramuscular administration. VIVITROL injection site reactions may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Alcohol dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

The most common adverse events associated with VIVITROL in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions and injection site reactions.

Please see VIVITROL Full Prescribing Information, including box warning by clicking on the link at the bottom of this page.
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