The pharmaceutical company Alkermes has developed a Medication Guide for patients being treated with Vivitrol. Vivitrol (naltrexone for extended-release injectable suspension) is administered intramuscularly to treat alcohol dependence. The Medication Guide highlights what patients need to know about Vivitrol treatment, including side effects, what to avoid during treatment, and what to tell their health care provider. The guide should be given to patients before starting Vivitrol and before each injection. Healthcare professionals should also counsel patients about the risks and benefits of receiving the drug, and ensure that patients understand the risks. FDA is also reminding practitioners that Vivitrol should only be administered into the gluteal muscle using the customized needle that comes with the drug. Take care not to inject the medication intravenously. If a patient has significant gluteal fat, the needle may not be long enough to reach muscle tissue. Healthcare providers should consider alternative treatment for these patients. Vivitrol should not be injected subcutaneously or into fatty tissue, because this could increase the risk of serious injection site reactions. Instruct patients to report injection site symptoms that become worse over time or do not resolve after two weeks, including intense pain, an open wound, bruising, swelling, blisters or hardness. FDA Patient Safety News: July 2010 For more information, please see our website: www.accessdata.fda …
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