Substance Abuse Treatment Advisory

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

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, 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 recent 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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INDICATION1

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.

IMPORTANT SAFETY INFORMATION FOR VIVITROL1

VIVITROL is contraindicated in patients receiving opioid analgesics or with current physiologic opioid dependence, patients in acute opiate withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, or in patients who have previously exhibited hypersensitivity to naltrexone PLG, carboxymethylcellulose or any other components of the diluent.

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

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 administered as a gluteal intramuscular injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using the customized needle provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for intramuscular administration. VIVITROL injection site reactions may be followed by pain, tenderness, induration, swelling, erythema, bruising or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not improving may require prompt medical attention, including in some cases surgical intervention.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Alcohol dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. 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.

Please see VIVITROL Full Prescribing Information, including box warning by clicking on the link at the bottom of this page.