Important Safety Information About Serious Rash

A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug and is required by the Food and Drug Administration to ensure that the benefits of the drug outweigh its risks.

The goals of this REMS program are to:

• inform healthcare providers about the risk of serious skin rash and other hypersensitivity reactions, particularly in pediatric patients, treated with NUVIGIL or PROVIGIL
• inform patients about the serious risks associated with NUVIGIL and PROVIGIL

In order for Cephalon to provide a safety plan to ensure that NUVIGIL and PROVIGIL are prescribed and taken safely, Cephalon has worked with the FDA to develop materials to communicate the risk of serious skin rash and other hypersensitivity reactions in patients, particularly pediatric patients. The REMS program is designed to inform healthcare providers and patients about the potential risks with NUVIGIL and PROVIGIL. To learn more about serious risks, read the important safety information provided on this website, including the Medication Guide, and discuss it with your patients.

If you receive a report of a rash or other potential hypersensitivity reaction, please notify Cephalon immediately through our Medical Services Department at 1-800-896-5855.