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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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About VIVITROL
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Overview


Mechanism of action


Efficacy


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VIVITROL Preparation and Administration
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Mechanism of action

How VIVITROL works

1. VIVITROL mechanism of action
Naltrexone, the active ingredient in VIVITROL, is an opioid antagonist with highest affinity for the µ-opioid receptor.7

The neurobiological mechanisms responsible for the reduction in alcohol consumption observed in patients with alcohol dependence treated with naltrexone are not entirely understood.7

Preclinical data suggest that occupation of the opioid receptors by VIVITROL may result in the blockade of the neurotransmitters in the brain that are believed to be involved with alcohol dependence. This blockade may result in the reduction in alcohol consumption observed in patients taking VIVITROL.

2. Unique drug-delivery system
A single injection of VIVITROL delivers naltrexone for a month using a proven technology called Medisorb®.4,7
  • This technology encapsulates naltrexone in microspheres made of a biodegradable polymer called poly(d,l-lactide-co-glycolide) or PLG1
  • The PLG polymer has a history of safe use in humans in the form of absorbable sutures, abdominal mesh, bone plates, and other extended-release pharmaceuticals1

With this technology, naltrexone is steadily released as the polymer breaks down.

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.