Hepatic Injury with Excessive Dosing

• Naltrexone has the capacity to cause hepatocelullar injury when given in excessive doses.
• 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. Naltrexone does not appear to be a hepatotoxin at the recommended 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.
• Patients should be warned of the risk of hepatic injury and advised to stop the use of naltrexone and seek medical attention if they experience symptoms or acute hepatitis.

Approved Risk Evaluation and Mitigation Strategies (REMS)

Vivitrol (naltrexone) Extended-Release Injectable Suspension (PDF - 55KB)

Patient Counseling Information

• Naltrexone Hydrochloride

• Vivitrol

Package Inserts

Naltrexone