Naltrexone

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. VIVITROL contains naltrexone, an opioid antagonist, and 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. VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification. VIVITROL should be part of a comprehensive management program that includes psychosocial support.

Naltrexone is an opioid antagonist with highest affinity for the mu opioid receptor. Naltrexone has little or no opioid agonist activity.

VIVITROL must be prepared and administered by a healthcare provider. Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization. The recommended dose of VIVITROL is 380 mg delivered intramuscularly (deep) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided. VIVITROL must ONLY be administered as a deep intramuscular gluteal injection. See Full Prescribing Information for complete Directions for Use.

VIVITROL is contraindicated in: Patients receiving opioid analgesics. Patients with current physiologic opioid dependence. Patients in acute opioid withdrawal. Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids. Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent. Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent.

Vulnerability to Opioid Overdose: Following VIVITROL treatment, opioid tolerance is reduced from pretreatment baseline and patients are vulnerable to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing VIVITROL treatment. Attempts to overcome blockade may also lead to fatal overdose. Strongly consider recommending or prescribing an opioid reversal agent (e.g., naloxone, nalmefene) for the emergency treatment of opioid overdose. Injection Site Reactions: VIVITROL must be prepared and administered by a healthcare provider. In some cases, injection site reactions may be very severe. Some cases of injection site reactions required surgical intervention.

The following clinically significant adverse reactions are described elsewhere in the labeling: Accidental Opioid Overdose Injection Site Reactions Precipitated Opioid Withdrawal Hepatotoxicity Depression and Suicidality Eosinophilic Pneumonia Hypersensitivity Reactions The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (i.e, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.

Patients taking VIVITROL may not benefit from opioid-containing medicines. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics.

The entire dose pack should be stored in the refrigerator (2 °C to 8 °C, 36 °F to 46 °F). Unrefrigerated, VIVITROL can be stored at temperatures not exceeding 25 °C (77 °F) for no more than 7 days prior to administration. Do not expose the product to temperatures above 25 °C (77 °F).