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VIVITROL®

VIVITROL® (naltrexone for extended­releaseinjectable suspension) is a once­monthly medicationfor the treatment of alcohol dependence as well as forthe prevention of relapse to opioid dependence,following opioid detoxification.

VIVITROL is the first and only non­narcotic, non­addictive, once­monthly medication approved for thetreatment of opioid dependence. Treatment with

VIVITROL should be part of a comprehensive management program that includes psychosocial support.

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For more information, visit www.vivitrol.com (http://www.vivitrol.com) .

Important Safety Information for VIVITROL® (naltrexone for extended­release injectable suspension)

IMPORTANT SAFETY INFORMATION

WHAT IS VIVITROL®?

VIVITROL (naltrexone for extended­release injectable suspension) 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 opioid­containing medications before starting VIVITROL.

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.

DO NOT TAKE VIVITROL IF YOU:

Are still using or still have any symptoms of physical withdrawal due to dependence on opioid street drugs oropioid­containing medicines.Have opioid withdrawal symptoms.Are allergic to naltrexone or any of the ingredients in VIVITROL or the liquid used to mix VIVITROL.

See the Medication Guide for more information about opioid withdrawal and the ingredients in VIVITROL and theliquid used to mix it.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT VIVITROL?

VIVITROL can cause serious side effects, including:

RISK OF OPIOID OVERDOSE

Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, seriousinjury, coma, or death. To avoid accidental overdose:

Do not take large amounts of opioids or try to overcome the opioid­blocking effects of VIVITROL.Do not use opioids in amounts that you used before VIVITROL treatment. You may even be more sensitive tolower amounts of opioids:

After detoxWhen 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; feel faint, dizzy, confused; or have other unusual symptoms.

SEVERE REACTIONS AT THE INJECTION SITE

VIVITROL may cause severe injection site reactions, including tissue death. Some injection site reactions haverequired surgery. Call your doctor right away if you notice any of the following at your injection site:

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Intense painThe area feels hardSwellingLumpsBlistersAn open woundA dark scab

Tell your doctor about any injection site reaction that concerns you, gets worse overtime or does not get better bytwo weeks after the injection.

SUDDEN OPIOID WITHDRAWAL

To avoid sudden opioid withdrawal, you must stop taking any opioids or opioid­containing medications, includingbuprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. If your doctor decides that youdon’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat suddenopioid withdrawal.

Sudden opioid withdrawal can be severe and may require hospitalization.

LIVER DAMAGE OR HEPATITIS

Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis. Tell your doctor if you have anyof the following symptoms of liver problems during VIVITROL treatment:

Stomach area pain lasting more than a few daysYellowing of the whites of your eyesDark urineTiredness

OTHER POSSIBLE SIDE EFFECTS

VIVITROL can cause other serious side effects, such as:

Depressed mood – Sometimes this leads to suicide or suicidal thoughts and behavior. Tell those closest toyou that you are taking VIVITROL. You or those closest to you should call your doctor right away if youbecome depressed or have any new or worsening depression symptoms.Allergic pneumonia – Tell your healthcare provider if you have shortness of breath, wheezing, or a coughthat doesn’t go away.Serious allergic reactions – Get medical help immediately if you have a skin rash; swelling of your face,eyes, mouth, or tongue; trouble breathing or wheezing; chest pain; or are feeling dizzy or faint.

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 opioiddependence 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 yourdoctor right away if you have any side effect that does not go away. See the attached Medication Guide for moreinformation.

Call your doctor for medical advice about any side effects. You are encouraged to report negative side effectsto the FDA. Visit www.fda.gov/medwatch (http://www.fda.gov/medwatch) or call 1­800­FDA­1088.

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