Overview :: A comprehensive approach offers alcohol dependent patients the best chance of recovery

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To address the considerable burden of chronic unhealthy drinking
A comprehensive approach offers alcohol dependent patients the best chance of recovery11

A disease with a staggering health and economic burden

17.6 million adults abuse alcohol or are alcohol dependent5
Alcohol consumption is 3rd among actual causes of death6
40% of adults report exposure to problem drinkers in their families7
At least 25% of all general hospital admissions are associated with alcoholism7
Alcohol dependent individuals use health services at twice the rate of the general population8
Alcohol abuse and dependence costs the US economy $184.6 billion annually9^,10
Economic impact of alcohol dependence is greater than high blood pressure, asthma, and diabetes combined10

Both psychosocial and medication-assisted recovery are widely supported

	AMA (American Medical Association)12
	APA (American Psychiatric Association)13
	NCADD (National Council on Alcoholism and Drug Dependence)14

"A combination of medication and behavioral therapies is most successful.15"

–US Department of Health and Human Services, Substance Abuse and Mental Health Services Administration

"The different approaches—medications for alcohol dependence, professional counseling, and mutual help groups—are complementary. They share the same goals while addressing different aspects of alcohol dependence: neurobiological, psychological, and social.16"

–National Institute on Alcohol Abuse and Alcoholism, National Institutes of Health

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.