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Data Presented at Two Global Medical Congresses Reinforce Benefit of Enbrel® (etanercept) for Patients with Chronic Inflammatory Conditions
Date:5/25/2011

e due to bacteria, mycobacteria, fungi, and viruses.  Opportunistic infections have also been reported.  Patients who develop a new infection while undergoing treatment with ENBREL should be monitored closely.  Administration of ENBREL should be discontinued if a patient develops a serious infection.

Caution should be exercised when considering the use of ENBREL in patients with a history of recurring or chronic infections or underlying conditions which may predispose patients to infections.  Treatment with ENBREL should not be initiated in patients with sepsis or risk of sepsis, or in patients with serious active infections.

Before initiation of therapy with ENBREL, any patient at increased risk for tuberculosis (TB) should be evaluated for active or latent infection.  Prophylaxis of latent TB infection should be initiated prior to therapy with ENBREL.  Physicians should monitor patients receiving ENBREL for signs and symptoms of active TB, including patients who tested negative for latent tuberculosis infection.  Applicable local guidelines should be consulted.  

Reports of malignancies affecting various sites have been received in the postmarketing period.  In clinical trials of TNF antagonists, more cases of lymphoma were seen among patients receiving a TNF antagonist compared to control patients.  However, there is an increased background lymphoma risk in RA patients with long-standing, highly active, inflammatory disease.  Combining the results of controlled portions of clinical trials of ENBREL, more cases of melanoma and non-melanoma skin cancer were seen in patients receiving ENBREL compared with control patients, particularly in patients with psoriasis.  A possible risk for the development of lymphomas or other malignancies in patients treated with an anti-TNF agent cannot be excluded.

Do not start ENBREL in patients with hypersensitivity to ENBREL or its components. &#
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SOURCE Amgen
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