CAMBRIDGE, Mass -- August 4, 2008 -- The Russian Regulatory Authorities have approved naltrexone (VIVITROL) extended-release injectable suspension for the treatment of alcohol dependence.
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses, and 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 5-fold or less.
Naltrexone is contraindicated in patients receiving or dependent on opioids, in acute opioid withdrawal, and in those who have failed the naloxone challenge test, or have a positive urine screen for opioids. Patients must be opioid free for a minimum of 7 to 10 days before treatment.
The most common adverse events in clinical trials were nausea, vomiting, headache, dizziness, asthenic conditions, and injection-site reactions.
SOURCE: Alkermes, Inc.
