Vivitrol (Naltrexone) is an opioid antagonist. Opioid-dependent patients, including those being treated for alcohol dependence, must be opioid-free at the time of initial Naltrexone administration. Therapy with naltrexone injection should be part of a comprehensive management program that includes psychosocial support. Naltrexone is used 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 Naltrexone. Patients should not be actively drinking at the time of initial Naltrexone administration. Naltrexone is used for the prevention of relapse to opioid dependence, following opioid detoxification.
Dosage: The recommended naltrexone dose is 380 mg, should be delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a health specialist as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection, using the carton components provided. Naltrexone injection must not be administered intravenously or subcutaneously. If a patient misses a dose of naltrexone, he or she should be instructed to receive the next dose as soon as possible.
Side Effects: The most commonly reported naltrexone side effects include:
- Painful joints
- Muscle cramps
- Cold symptoms
- Trouble sleeping
- Decreased appetite
Warnings and Precautions:
- The naltrexone uses are restricted in acute hepatitis or liver failure, and its use in patients with active liver disease must be precisely considered in light of its hepatotoxic effects.
- Patients with vivitrol 380 mg injection should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention if they develop symptoms of pneumonia.
- Patients with vivitrol injection should be warned of the risk of hypersensitivity reactions, including anaphylaxis. If these reactions occur, patients should seek prompt medical attention.
- Patients treated for alcohol dependence with naltrexone 380 mg should be evaluated for underlying opioid dependence and for any recent use of opioids prior to initiation of naltrexone therapy.
- Alcohol- and opioid-dependent patients, including those who are with naltrexone dosage, should be assessed for the development of depression or suicidal thinking.
- Patients should notify their health specialist if they become pregnant or intend to become pregnant or are breast-feeding while on naltrexone therapy.