cannot be confirmed, and for patients with anegative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physicianwith expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating antituberculosistherapy is appropriate for an individual patient.
Tuberculosis should be strongly considered in patients who develop a new infection during Eticovo treatment,especially in patients who have previously or recently traveled to countries with a high preva lence of tuberculosis, orwho have had close contact with a person with active tuberculosis.
Invasive Fungal Infections
Cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNFblockers, including etanercept products. For patients who reside or travel in regions where mycoses are endemic,invasive fungal infection should be suspected if they develop a serious systemic illness. Appropriate empiric antifungaltherapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing forhistoplasmosis may be negative in some patients with active infection. When feasible, the decision to administerempiric anti-fungal therapy in these patients should be made in consultation with a physician with expertise in thediagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungalinfection and the risks of anti-fungal therapy. In 38 etanercept clinical trials and 4 cohort studies in all approvedindications representing 27,169 patient-years of exposure (17,696 patients) from the United States and Canada, nohistoplasmosis infections were reported among patients treated with etanercept.
5.2 Neurologic Reactions
Treatment with TNF-blocking agents, including etanercept products, has been associated with rare (< 0.1%) cases ofnew onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental statuschanges and some associated with permanent disability, and with peripheral nervous system demyelinating disorders.
Cases of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barre syndromes, other peripheraldemyelinating neuropathies, and new onset or exacerbation of seizure disorders have been reported in postmarketingexperience with etanercept products therapy. Prescribers should exercise caution in considering the use of Eticovo inpatients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders [see AdverseReactions (6.2)].
5.3 Malignancies
Lymphomas
In the controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observedamong patients receiving a TNF-blocker compared to control patients.
During the controlled portions of etanercepttrials in adult patients with RA, AS, and PsA, 2 lymphomas were observed among 3306 etanercept-treated patientsversus 0 among 1521 control patients (duration of controlled treatment ranged from 3 to 36 months).
Among 6543 adult rheumatology (RA, PsA, AS) patients treated with etanercept in controlled and uncontrolledportions of clinical trials, representing approximately 12,845 patient-years of therapy, the observed rate of lymphomawas 0.10 cases per 100 patient-years. This was 3-fold higher than the rate of lymphoma expected in the general U.S.
population based on the |
