VIVITROL is a prescription injectable medicine used to:

•Treat alcohol dependence. You should stop drinking before starting VIVITROL.

•Prevent relapse to opioid dependence after opioid detox. You must stop taking opioids or other opioid-containing medications before starting VIVITROL.

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Is there a risk of opioid overdose with VIVITROL?

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Yes. One serious side effect of VIVITROL is the risk of opioid overdose. Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death.

• Do not take large amounts of opioids or try to overcome the opioid-blocking effects of VIVITROL.

• Do not use opioids in amounts that you used before VIVITROL treatment. You may even be more sensitive to lower amounts of opioids:

• After detox

• When your next VIVITROL dose is due

• If you miss a dose of VIVITROL

• After you stop VIVITROL treatment

Get emergency medical help right away if you:

• have trouble breathing

• become very drowsy with slowed breathing

• have slow, shallow breathing (little chest movement with breathing)

• feel faint, dizzy, confused or have other unusual symptoms.

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.

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Is there a risk of severe reactions at the injection site with VIVITROL?

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Yes. One serious side effect of VIVITROL is severe reactions at the site of the injection, including tissue death. Some injection site reactions have required surgery. Call your healthcare provider right away if you notice any of the following at your injection site:

• Intense pain

• The area feels hard

• Swelling

• Lumps

• Blister

• An open wound

• A dark scab

Tell your healthcare provider about any injection site reaction that concerns you, gets worse over time, or does not get better by two weeks after the injection.

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Is there a risk of sudden opioid withdrawal when starting VIVITROL?

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Yes. One serious side effect of VIVITROL is 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 healthcare provider 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.

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VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, severe reaction at the injection site and sudden opioid withdrawal.