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 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.
Read the complete MedWatch 2010 Safety summary, including links to the Dear HCP letter, the revised Prescribing Information and the new Medication Guide, at:
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
good morning all. Life has been very VERY crazy in NE Ohio in the DollyCali household. MANY severe illnessess/accidents & funerals the past month with family & close friends
Just checking in with a cyber hug to my pals here.