Amgen and Wyeth have announced that the prescribing information for Enbrel (etanercept) has been updated. The previously bolded warning relating to the risk of infections and tuberculosis (TB) is now a boxed warning and includes additional language regarding screening and monitoring patients for TB, including patients who tested negative for latent TB infection. The boxed warning states that reports of TB in patients receiving tumor necrosis factor (TNF) inhibitors, including Enbrel, may be due to reactivation of latent TB infection or to new infection. The adverse reactions section has also been updated to include the reported incidences of TB infection observed in clinical studies.
The juvenile rheumatoid arthritis (JRA) indication was also changed. Enbrel now has an updated juvenile idiopathic arthritis (JIA), formerly JRA, indication for reducing the signs and symptoms of moderately-to-severely active polyarticular JIA in patients ≥2 years of age.
For more information call (888) 4ENBREL or visit www.enbrel.com.