Vivitrol

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.

VIVITROL is contraindicated for individuals who are taking legal or illegal opioids, or those in opioid withdrawal, or those who are hypersensitive to any of the components of VIVITROL.
Before beginning VIVITROL treatment, patients must be opioid-free for a minimum of 7-10 days. VIVITROL has not been tested for geriatric or pediatric patients.

VIVITROL is provided as a carton containing a vial each of VIVITROL microspheres and diluents, one 5-mL syringe, one ?-inch 20-gauge preparation needle, and two 1?-inch 20-gauge administration needles with safety device. The dosage strength is 380-mg naltrexone per vial. The intramuscular shot should be given monthly.

The efficacy of VIVITROL in the treatment of alcohol dependence was evaluated in a 24-week, placebo-controlled, multi-center, double-blind, randomized trial of alcohol dependent (DSM-IV criteria) outpatients. Subjects were treated with an injection every 4 weeks of VIVITROL 190 mg, VIVITROL 380 mg or placebo. Oral naltrexone was not administered prior to the initial or subsequent injections of study medication. Psychosocial support was provided to all subjects in addition to medication.

Subjects treated with VIVITROL 380 mg demonstrated a greater reduction in days of heavy drinking than those treated with placebo. Heavy drinking was defined as self-report of 5 or more standard drinks consumed on a given day for male patients and 4 or more drinks for female patients. 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 and the number of heavy drinking days.

In this subset, patients treated with VIVITROL were also more likely than placebo-treated patients to maintain complete abstinence throughout treatment. The same treatment effects were not evident among the subset of patients (n=571, 92% of the total study population) who were actively drinking at the time of treatment initiation.

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