erious infections involving various organ systemsand sites that may lead to hospitalization or death.
Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunisticpathogens including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis,listeriosis, pneumocystosis, and tuberculosis have been reported with TNF blockers. Patients have frequentlypresented with disseminated rather than localized disease.
Treatment with Eticovo should not be initiated in patients with an active infection, including clinically importantlocalized infections. Patients greater than 65 years of age, patients with co-morbid conditions, and/or patients takingconcomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Therisks and benefits of treatment should be considered prior to initiating therapy in patients:
With chronic or recurrent infection;
Who have been exposed to tuberculosis;
With a history of an opportunistic infection;
Who have resided or traveled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis,coccidioidomycosis, or blastomycosis; or
With underlying conditions that may predispose them to infection, such as advanced or poorly controlleddiabetes [see Adverse Reactions (6.1)].
Patients should be closely monitored for the development of signs and symptoms of infection during and after
treatment with Eticovo.
Eticovo should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a newinfection during treatment with Eticovo should be closely monitored, undergo a prompt and complete diagnosticworkup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.
Tuberculosis
Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receivingetanercept products, including patients who have previously received treatment for latent or active tuberculosis. Datafrom clinical trials and preclinical studies suggest that the risk of reactivation of latent tuberculosis infection is lowerwith etanercept than with TNF-blocking monoclonal antibodies. Nonetheless, postmarketing cases of tuberculosis
reactivation have been reported for TNF blockers, including etanercept products. Tuberculosis has developed inpatients who tested negative for latent tuberculosis prior to initiation of therapy. Patients should be eva luated fortuberculosis risk factors and tested for latent infection prior to initiating Eticovo and periodically during therapy. Testsfor latent tuberculosis infection may be falsely negative while on therapy with Eticovo.
Treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce therisk of tuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skin testing should beconsidered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiatingEticovo, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).
Anti-tuberculosis therapy should also be considered prior to initiation of Eticovo in patients with a past history oflatent or active tuberculosis in whom an adequate course of treatment |
