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| |  Etanercept PI Gets Boxed Warning for Risk of Infections, Tuberculosis THOUSAND OAKS, Calif, and COLLEGEVILLE, Pa -- March 17, 2008 -- The US Food and Drug Administration-approved US Prescribing Information (PI) for etanercept (Enbrel) has been updated to include a boxed warning relating to the risk of infections, including tuberculosis. This warning is similar to labelling for other medicines in the tumour necrosis factor (TNF) inhibitor class. The PI had previously included a bolded warning regarding the risk of infections and tuberculosis. This information is now in a boxed warning and includes additional language regarding screening and monitoring patients for tuberculosis, including patients who tested negative for latent tuberculosis infection. In addition, the boxed warning states that tuberculosis has been observed in patients receiving TNF-blocking agents, including etanercept, and that tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection. The boxed warning notes that data from clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lower with etanercept than with TNF-blocking monoclonal antibodies. The boxed warning further notes that, nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including etanercept. The risks defined in the boxed warning are consistent with the risk of tuberculosis and infections that have been included in previous versions of the US PI. The primary concern of the manufacturers of etanercept -- Amgen and Wyeth Pharmaceuticals, a division of Wyeth -- is for the safety of patients, and both companies maintain an ongoing pharmacovigilance program to analyse and evaluate all safety reports from clinical and open-label trials as well as postmarketing surveillance. Other PI updates include the addition of reported incidence of tuberculosis infection observed in clinical studies in the Adverse Reactions section. In global clinical studies of more than 20,000 patients, tuberculosis was observed in approximately 0.01% of patients. In more than 15,000 patients from clinical studies in the United States and Canada, tuberculosis was observed in approximately 0.007% of patients. The Adverse Reaction Information from Spontaneous Reports section was also updated based on postmarketing surveillance reports. Additional information was added regarding antibody assays in the immunogenicity section. The indication within the US PI for juvenile idiopathic arthritis (JIA), formerly called juvenile rheumatoid arthritis (JRA), also was changed. Etanercept now has an updated JIA indication for reducing the signs and symptoms of moderately to severely active polyarticular JIA in patients aged 2 years and older. In addition to these US PI updates, the current patient package insert (PPI) for etanercept will be replaced with a Medication Guide when it becomes available. Patients will receive the Medication Guide when a prescription for etanercept is dispensed in the United States. As with the current PPI, Amgen and Wyeth will distribute the Medication Guide in conjunction with any company-sponsored patient communications about etanercept. The manufacturers are informing healthcare professionals about the revisions to the US PI through a "Dear Healthcare Professional" letter and will post the letter and updated PI on www.enbrel.com. Additional information can be obtained at 1-888-4ENBREL.
SOURCE: Amgen
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