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About VIVITROL
VIVITROL clinical trial results


Benefits of once-a-month dosing


Safety and tolerability


Dosage and administration


Patient types


What is Touchpoints?

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


Targeting the psychosocial and physical drivers

Enroll in the VIVITROL provider locator network

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.

Alkermes   
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 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, aesthetic conditions and injection site reactions.

Please see attached VIVITROL Full Prescribing Information, including box warning or at www.vivitrol.com