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VIVITROL (naltrexone for extended-release injectable suspension) VIVITROL: A Treatment Option For The Daily Struggle Against Alcohol Dependence. One dose all month long.
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Prescribing Information
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References
  1. Dean RL. The preclinical development of Medisorb® Naltrexone, a once a month long-acting injection, for the treatment of alcohol dependence. Front Biosci. 2005;10:643-655.
  2. 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;30:480-490.
  3. Garbutt JC, Kranzler HR, O’Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625. Errata in: JAMA. 2005;293(16):1978. JAMA. 2005;293(23):2864.
  4. Hutchinson FG, Furr BJA. Design of biodegradable polymers for controlled release. Chapter 6. In: Drug Delivery Systems 106-119.
  5. National Institute on Alcohol Abuse and Alcoholism. Alcoholism: getting the facts. NIH publication No. 96-4153. Available at: http://pubs.niaaa.nih.gov/publications/GettheFacts_HTML/facts.htm. Accessed October 14, 2005.
  6. Pettinati HM, Volpicelli JR, Pierce JD Jr, O’Brien CP. Improving naltrexone response: an intervention for medical practitioners to enhance medication compliance in alcohol dependent patients. J Addict Dis. 2000;19:71-83.
  7. VIVITROL™ (naltrexone for extended-release injectable suspension) full Prescribing Information. Alkermes, Inc; 2005.
  8. VIVITROL™ (naltrexone for extended-release injectable suspension) Patient Package Insert. Alkermes, Inc; 2005.
  9. National Institute on Alcohol Abuse and Alcoholism. Helping Patients Who Drink Too Much: A Clinician's Guide. Bethesda, Md: National Institutes of Health; 2005. NIH publication 05-3769. Available at: http://pubs.niaaa.nih.gov/publications/Practitioner/CliniciansGuide2005/guide.pdf. Accessed July 12, 2006.
Important Safety Information
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 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.