Benefits of once-a-month dosing :: VIVITROL Information

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VIVITROL offers the benefits of once-a-month dosing

VIVITROL eliminates daily medication-adherence decisions2

Medication-assisted recovery in alcohol dependent patients is frequently undermined by patient nonadherence

To date, medications for alcohol dependence have been limited to oral treatments, some taken up to 3 times a day. Once-a-month VIVITROL eliminates the dosing challenges of oral treatments.2

Medication is released continuously over 30 days23

*Data for oral naltrexone beyond Day 5 have been extrapolated from a study of normal healthy volunteers (n=14) given oral naltrexone 50 mg daily for 5 days.23

"With injectable naltrexone, one intramuscular injection is effective for 4 weeks, reducing opportunities for patients to cease their medication.2"

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

Daily oral naltrexone creates fluctuating plasma concentrations* of medication throughout the day23
Once-a-month VIVITROL (XR-NTX 380 mg) delivers only ¼ of the cumulative dose of 1 month of daily oral naltrexone (1500 mg)23

Plasma concentrations do not necessarily correlate with clinical efficacy
The above results are from a head-to-head study comparing the pharmacokinetics of oral naltrexone to VIVITROL23

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 Information1

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, carboxymethylcellulose, 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.