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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US Department of Health and Human Services Releases Information About VIVITROL for the Treatment of Alcoholism

The Substance Abuse and Mental Health Services Administration (SAMHSA), a public health agency within the US Department of Health and Human Services, issued its quarterly Substance Abuse Treatment Advisory developed for the education of healthcare professionals in the field of substance abuse. The advisory features a comprehensive overview of VIVITROL® (naltrexone for extended-release injectable suspension), the first and only once-monthly injectable medication for the treatment of alcohol dependence, which was approved by the FDA in April 2006.

This overview includes the following information about VIVITROL:

  • Mechanism of Action
  • Dosage and Prescribing Information
  • Side Effects
  • What to tell the patient
  • And more

Download the Substance Abuse Treatment Advisory
Click here to download a PDF of the Substance Abuse Treatment Advisory.

This advisory follows the publication of an updated version of "Helping Patients Who Drink Too Much, A Clinician's Guide" from the National Institute on Alcohol Abuse and Alcoholism (NIAAA). The Guide was recently updated to include information about VIVITROL as the most recently FDA-approved medication for the treatment of alcohol dependence. Learn more

Disclaimer: The Substance Abuse Treatment Advisory does not provide complete information on VIVITROL and is not meant to be a substitute for the full VIVITROL Prescribing Information. Inclusion of the Substance Abuse Treatment Advisory should not be viewed as an SAMHSA endorsement of any particular pharmaceutical company or its products or services.


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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.