Positive Information About VIVITROL For Treatment Of Alcoholism Released

Alcohol Dependence

Substance Abuse and Mental Health Services Administration features a comprehensive overview of VIVITROL (naltrexone for extended- release injectable suspension), the once-monthly injectable medication for the treatment of alcohol dependence.

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.

"We are pleased that these government organizations have formally recognized VIVITROL, the first and only once-monthly injectable medication for the treatment of alcohol dependence, as an important and effective treatment option in their recent publications," said David Gastfriend, MD, Vice President, Medical Affairs at Alkermes. "We encourage healthcare providers, including addiction specialists and primary care doctors, to utilize this valuable information as they evaluate and treat their patients who struggle with the deadly disease of alcoholism."

VIVITROL is a once-monthly, single dose 380 mg intramuscular gluteal injection indicated for patients who are able to abstain from drinking alcohol in an outpatient setting and who are not actively drinking prior to treatment initiation. VIVITROL should be used as part of a comprehensive management program that includes ongoing counseling or group therapy.

VIVITROL, a long-acting form of naltrexone, is effective and generally well tolerated for the treatment of alcohol dependence. In clinical trials, when used in combination with psychosocial support, VIVITROL was shown to reduce the number of drinking days and heavy drinking days and to prolong and maintain abstinence in patients who abstained from alcohol the week prior to starting treatment.

The proprietary Medisorb drug delivery technology utilized in VIVITROL allows the medication to be gradually released into the body at a controlled rate over a one-month time period, providing patients with convenient monthly dosing, which alleviates the need for patients to make daily medication decisions.

VIVITROL is non-addictive - patients did not develop a tolerance for or dependence on VIVITROL. VIVITROL is non-aversive, meaning patients do not become ill as a result of drinking alcohol while on VIVITROL.

VIVITROL should be administered by a healthcare provider. Ongoing interactions with healthcare professionals strengthen the therapeutic alliance and collaborative relationship healthcare professionals form with patients, which is an important component in the recovery process.

VIVITROL works by binding to opioid receptors in the brain. Although the mechanism responsible for reduction in alcohol consumption is not entirely understood, preclinical data suggest that occupation of the opioid receptors by VIVITROL may result in the blockade of the neurotransmitters in the brain believed to be involved with the pleasurable and rewarding effects of alcohol. This blockade may result in the reduction in alcohol consumption observed in patients treated with VIVITROL.

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 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; and in those with previous hypersensitivity to naltrexone, PLG, carboxymethylcelluose, or any other components of the diluent.

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 fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in 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.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Injection site reactions not improving may require prompt medical attention. Alcohol-dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thinking. 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.