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VIVITROL (naltrexone for extended-release injectable suspension) VIVITROL: A Treatment Option For The Daily Struggle Against Alcohol Dependence. One dose all month long.
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About VIVITROL
My Path to Recovery
Overview


Mechanism of action


Efficacy


Dosage/Administration


Adherence


Safety Considerations


VIVITROL Preparation and Administration
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Efficacy

Results from clinical trials

6-month clinical trial
The rationale for the use of VIVITROL 380 mg is based on efficacy data from the pivotal 6-month phase III study, and safety and tolerability data from a number of other clinical trials, including this study.
  • This multicenter, double-blind, placebo-controlled trial involved DSM-IV outpatients who were alcohol dependent3
  • Patients received a once-monthly gluteal IM injection of VIVITROL
  • Among the subset of patients (n=53, 8% of the total study population) who abstained completely from drinking during the week prior to the first dose of medication, compared with placebo-treated patients, those treated with VIVITROL 380 mg had greater reductions in the number of drinking days (97% difference, P=0.02) and the number of heavy drinking days (92% difference, P<0.05). In this subset, 40% of patients treated with VIVITROL plus psychosocial support were also more likely than placebo-treated patients to maintain complete abstinence throughout treatment.
  • No lead-in with oral naltrexone was administered
  • The standardized psychosocial intervention used with all subjects was BRENDA, which consists of biopsychosocial assessment, reporting the assessment to the patient, an empathetic approach, identified and stated patient needs, direct advice regarding drinking behavior, and assessment of treatment adherence
  • Heavy drinking was defined as ≥5 drinks per day for men, ≥4 drinks per day for women3,7

Important Safety Information
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 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.