The active ingredient in VIVITROL® (naltrexone for extended-release injectable suspension) — naltrexone — works as a “blocker.” It attaches to certain opioid receptors in your brain and blocks the pleasurable feelings associated with taking opioids.
Even though VIVITROL may block the intense high from opioids, it does not prevent good feelings that come from other naturally pleasurable activities.
After you get a dose of VIVITROL, its blocking effect slowly decreases and completely goes away over time. It is important to know that you should not try to overcome the VIVITROL blockade by taking opioids. Using opioids in the amounts you used before starting VIVITROL treatment, or even lower amounts, could lead to overdose or death.
Please read below for more important safety information including more about these serious side effects.
Please read below for more important safety information.
VIVITROL is a prescription injectable medicine used to:
VIVITROL must be used with other alcohol or drug recovery programs such as counseling.
VIVITROL may not work for everyone and has not been studied in children.
See the Medication Guide for more information about opioid withdrawal and the ingredients in VIVITROL and the liquid used to mix it.
Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death. To avoid accidental overdose:
Get emergency medical help right away if you have trouble breathing; become very drowsy with slowed breathing; have slow, shallow breathing; feel faint, dizzy, confused; or have other unusual symptoms.
VIVITROL may cause severe injection site reactions, including tissue death. Some injection site reactions have required surgery. Call your doctor right away if you notice any of the following at your injection site:
Tell your doctor about any injection site reaction that concerns you, gets worse over time or does not get better by two weeks after the injection.
To avoid sudden opioid withdrawal, you must stop taking any opioids or opioid-containing medications, including buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. If your doctor decides that you don’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat sudden opioid withdrawal.
Sudden opioid withdrawal can be severe and may require hospitalization.
Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis. Tell your doctor if you have any of the following symptoms of liver problems during VIVITROL treatment:
VIVITROL can cause other serious side effects, such as:
Common side effects of VIVITROL include nausea, tiredness, headache, dizziness, vomiting, decreased appetite, painful joints, and muscle cramps; in addition, common side effects in people taking VIVITROL for opioid dependence also include cold symptoms, trouble sleeping, and toothache.
These are not all of the side effects of VIVITROL. For more information, ask your healthcare provider. Tell your doctor right away if you have any side effect that does not go away. See the Medication Guide for more information.
Call your doctor for medical advice about any side effects. You are encouraged to report negative side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
See the Medication Guide.