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Vivitrol (Naltrexone) - Summary

 
 



BOX WARNING

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 SUMMARY

VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity.

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.


See all Vivitrol indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Vivitrol (Naltrexone)

Low-dose naltrexone for the treatment of fibromyalgia: Findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. [2013]
fatigue... CONCLUSION: The preliminary evidence continues to show that low-dose naltrexone

Effectiveness of naltrexone in the prevention of delayed respiratory arrest in opioid-naive methadone-intoxicated patients. [2013]
Acute methadone toxicity is a major public health concern in Iran... Further studies are warranted before the generalization of this approach to other patient populations.

Naltrexone with or without guanfacine for preventing relapse to opiate addiction in St.-Petersburg, Russia. [2013]
induced craving and have reduced opiate relapse in small clinical trials... CONCLUSIONS: Adding guanfacine to naltrexone did not improve treatment retention

Low-dose naltrexone for the treatment of fibromyalgia: findings of a small, randomized, double-blind, placebo-controlled, counterbalanced, crossover trial assessing daily pain levels. [2013]
fatigue... CONCLUSION: The preliminary evidence continues to show that low-dose naltrexone

Evaluation of naltrexone for dissociative symptoms in borderline personality disorder. [2012.01]
Data from a pilot study suggest that naltrexone might reduce dissociative symptoms in patients with borderline personality disorder. However, the interpretation of these data is limited by the lack of a control group and by the nonblind nature of this study...

more studies >>

Clinical Trials Related to Vivitrol (Naltrexone)

VIVITROL as a Treatment for Cocaine and Alcohol Dependence [Recruiting]

Naltrexone for Heavy Drinking in Young Adults [Recruiting]
In this study, 132 heavy drinking young adults (aged 18-25) will be provided with brief counseling and either naltrexone, a medication that is FDA-approved for the treatment of alcohol dependence, or placebo over the course of 8 weeks. A novel strategy will be used for administering low-dose naltrexone, in which daily dosing will be combined with targeted dosing in anticipation of high-risk situations. The main hypotheses are that daily + targeted naltrexone will result in greater reductions in frequency of heavy and any drinking compared with daily + targeted placebo.

Extended Release Naltrexone for Treating Amphetamine Dependence in Iceland [Not yet recruiting]
Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.

Naltrexone and Hypoglycemia in Type 1 Diabetes [Recruiting]
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death.

Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia.

The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.

Combined Pharmacotherapies for Alcoholism [Recruiting]
This study would like to test whether the combination of ondansetron and naltrexone will be superior to either medication alone or placebo in the treatment of alcohol dependence.

more trials >>

Reports of Suspected Vivitrol (Naltrexone) Side Effects

Death (18)Injection Site Pain (8)Overdose (7)Injection Site Reaction (7)Depression (7)Nausea (6)Treatment Noncompliance (5)Injection Site Abscess (5)Insomnia (5)Confusional State (4)more >>


Page last updated: 2014-12-01

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