sts for latent tuberculosis infection may be falsely negative while on therapy with ENBREL®.
ENBREL® should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with ENBREL® should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.
In 38 ENBREL® clinical trials and 4 cohort studies in all approved indications representing 27,169 patient years of exposure (17,696 patients) from the United States and Canada, no histoplasmosis infections were reported among patients treated with ENBREL®. Nonetheless, post marketing cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including ENBREL®. 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 antifungal therapy should be considered while a diagnostic workup is being performed. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. When feasible, the decision to administer empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of antifungal therapy.
In a 24-week study of concurrent ENBREL® and anakinra therapy, the rate of serious infections in the combination arm (7%) was higher than with ENBREL® alone (0%). The combination of ENBREL® and anakinra did not result in higher ACR response rates compared to ENBREL® alone (see CLINICAL STUDIES: Clinical Response and ADVERSE REACTIONS: Infections). Concurrent therapy with ENBREL® and anakinra is not recommended.
Neurologic Events
Treatment with ENBREL® and other agents that inhibit TNF have been associated with rare cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability. Cases of transverse myelitis, optic neuritis, multiple sclerosis, and new onset or exacerbation of seizure disorders have been observed in association with ENBREL® therapy. The causal relationship to ENBREL® therapy remains unclear. While no clinical trials have been performed eva luating ENBREL® therapy in patients with multiple sclerosis, other TNF antagonists administered to patients with multiple sclerosis have been associated with increases in disease activity.7, 8 Prescribers should exercise caution in considering the use of ENBREL® in patients with preexisting or recent-onset central nervous system demyelinating disorders (see ADVERSE REACTIONS).
Hematologic Events
Rare reports of pancytopenia including aplastic anemia, some with a fatal outcome, have been reported in patients treated with ENBREL®. The causal relationship to ENBREL® therapy remains unclear. Although no high risk group has been identified, caution should be exercised in patients being treated with ENBREL® who have a previous history of significant hematologic abnormalities. All patients should be advised to seek immediate medical attention if they develop si |
