October 25, 2010
REMS approved for Nuvigil and ProvigilCephalon announced that the FDA has approved Risk Evaluation and Mitigation Strategies (REMS) for its medications Nuvigil (armodafinil tablets) and Provigil (modafinil tablets). The goal of each REMS is to inform healthcare providers, patients and caregivers about the risks associated with these medications (eg, serious skin rash and hypersensitivity reactions). Current product labeling for both medications contains a bolded warning that includes these risks. In accordance with the approved REMS, Cephalon is currently updating Nuvigil and Provigil labeling to include a Medication Guide to inform patients about the potential risks associated with the use of these medications.
The Nuvigil and Provigil Medication Guides will be available on each product website, www.nuvigil.com and www.provigil.com, and will be dispensed with every prescription.
Nuvigil and Provigil are indicated to improve wakefulness in patients with excessive sleepiness associated with with obstructive sleep apnea/hypopnea syndrome (OSAHS), narcolepsy and shift work sleep disorder (SWSD); and as adjuncts to standard treatment for underlying airway obstruction in OSAHS.
For more information call (800) 896-5855 or visit www.cephalon.com.