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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 Infections

  • 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.


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Additional Information

Updated January 2018