Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients
Audience: Substance Abuse healthcare providers, patients
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 for Vivitrol 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.