Risk Evaluation and Mitigation Strategies (REMS) for Cephalon’s medications Nuvigil (armodafinil) Tablets [C-IV] and Provigil (modafinil) Tablets [C-IV] have been approved by the US Food and Drug Administration (FDA).
Both the Nuvigil and Provigil REMS consist of a medication guide to inform patients about the potential risks associated with the use of these medications, a communication plan, and a timetable for submission of assessments of the REMS. The communication plan includes a Dear Healthcare Professional Letter, a Prescriber Brochure, a Pharmacist Action Letter, and a dedicated REMS Web site.
The goal of each REMS is to inform health care providers, patients, and caregivers about the risks associated with these medications, including serious skin rash and hypersensitivity reactions. The current product labeling for both medications contains a bolded warning that includes these risks. Neither medication is approved for use in the pediatric population for any indication. In accordance with the approved REMS, the company is currently updating Nuvigil and Provigil labeling to include the Medication Guide.
The Nuvigil and Provigil medication guides will be available on each product Web site, www.nuvigil.com and www.provigil.com, and will be dispensed with every prescription.