VIVITROL ® (naltrexone for extended-release injectable suspension) is an opioid antagonist with little, if any, opioid agonist activity. It is used in the treatment of alcohol and opioid addiction and dependence. It works by blocking the euphoria associated with opioid use and alcohol intoxication. Its major benefit is that it needs only to be administered once a month.
What is the most important information I should know about VIVITROL?
VIVITROL can cause serious side effects, including:
1. Risk of opioid overdose.
You can accidentally overdose in two ways.
It is important that you tell your family and the people closest to you of this
increased sensitivity to opioids and the risk of overdose.
You or someone close to you should get emergency medical help right away if you:
2. Severe reactions at the site of the injection (injection site reactions).
Some people on VIVITROL have had severe injection site reactions, including tissue death (necrosis). Some of these injection site reactions have required surgery. Call your healthcare provider right away if you notice any of the following at any of your injection sites:
Tell your healthcare provider about any reaction at an injection site that concerns you, gets worse over time, or does not get better by two weeks after the injection.
3. Sudden opioid withdrawal.
Anyone who receives a VIVITROL injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough,cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. Using opioids in the7 to 14 days before you start receiving VIVITROL may cause you to suddenly have symptoms of opioid withdrawal when you get the VIVITROL injection. Sudden opioid withdrawal can be severe, and you may need to go to the hospital.
You must be opioid-free before receiving VIVITROL unless your healthcare provider decides that you don't need to go through detox first. Instead, your doctor may decide to give your VIVITROL injection in a medical facility that can treat you for sudden opioid withdrawal.
4. Liver damage or hepatitis. Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis.
Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with VIVITROL:
Your healthcare provider may need to stop treating you with VIVITROL if you get signs or symptoms of a serious liver problem.
Who should not receive VIVITROL?
Do not receive VIVITROL if you:
What should I tell my healthcare provider before receiving VIVITROL?
Before you receive VIVITROL, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea.
See "What is the most important information I should know about VIVITROL?"
If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or opioid street drugs, it is important that you tell your healthcare provider before starting VIVITROL to avoid having sudden opioid withdrawal symptoms when you start VIVITROL treatment.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Information provided above is courtesy of: https://www.fda.gov
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