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U.S. Department of Health and Human Services

Safety

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Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients

Audience: Substance Abuse healthcare providers, patients

[Posted 05/04/2010] Alkermes and FDA notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009.

FDA requires that a Medication Guide, which communicates this and other important information about treatment be provided to all patients. Healthcare professionals should also counsel patients about the risks and benefits of Vivitrol before an initial prescription, including those risks and benefits set forth in the new Medication Guide and Prescribing Information, and should ensure that patients understand these risks.

[05/04/2010 - Dear Healthcare Professional Letter - Alkermes]
[03/2010 - Prescribing Information - Alkermes]
[12/2009 - Medication Guide - Alkermes]