Infection Risk; Tuberculosis
Risk of Infections
- Infections, including serious infections leading to hospitalization or death, have been observed in patients treated with etanercept (see WARNINGS and ADVERSE REACTIONS).
- Infections have included bacterial sepsis and tuberculosis.
- Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with etanercept
- Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, etanercept should be discontinued.
- Note: On 9/7/11, the FDA announced new revision to black box warning regarding the addition of the risk of infection from two bacterial pathogens, Legionella and Listeria. (See FDA Announcement below)
- Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving TNF-blocking agents, including etanercept.
- Tuberculosis may be due to reactivation of latent tuberculosis infection or to new infection.
- 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. Nonetheless, postmarketing cases of tuberculosis reactivation have been reported for TNF blockers, including etanercept.
- Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection prior to initiating etanercept and during treatment.
- Treatment of latent tuberculosis infection should be initiated prior to therapy with etanercept.
- Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving TNF blockers.
- Some patients who tested negative for latent tuberculosis prior to receiving etanercept have developed active tuberculosis.
- Physicians should monitor patients receiving etanercept for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.
Malignancy in Children and Adolescents
- Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including etanercept.
FDA and Industry Communications
- FDA Information on TNF Blockers
- Boxed Warning Revision for TNF Blockers: Addition of Risk of Listeria and Legionella Bacterial Infection (Sept 2011)
- Safety Review Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults Receiving TNF Blockers, Azathioprine and/or Mercaptopurine (April 2011)
- Boxed Warning Revision: TNF Blockers (November 2009)
- Revised Boxed Warnings Planned per FDA Safety Review: Increased Risk of Lymphomas and Other Malignancies in Children/Adolescents Treated with TNF Blockers (August 2009)
- Dear Health Professional Letter (March 2008)
Patient Counseling Information
Updated January 2018