Etanercept
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.
Patient counseling
REMS
Communications
Medical guidelines
Patient Medication Guide - ENBREL
Patient Medication Guide - ERELZI
Patient Medication Guide - ETICOVO
Package inserts
Additional information
Keywords: Enbrel
Updated: January 2018