Date:4/24/2008

e fungal infections, and other opportunistic infections, have been observed in patients receiving Cimzia(R). Some of these infections have been fatal. Anti-tuberculosis treatment of patients with latent tuberculosis infection reduces the risk of reactivation in patients receiving treatment with TNF blockers such as Cimzia(R). However, active tuberculosis has developed in patients receiving Cimzia whose tuberculin test was negative. Evaluate patients for tuberculosis risk factors and test for latent tuberculosis infection prior to initiating Cimzia(R) and during therapy. Initiate treatment of latent tuberculosis infection prior to therapy with Cimzia(R). Monitor patients receiving Cimzia(R) for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection. Consider anti-tuberculosis therapy prior to initiation of Cimzia(R) in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Serious infections, sepsis, and cases of opportunistic infections, including fatalities, have been reported in patients receiving TNF blockers, including Cimzia(R). Infections have been reported in patients receiving Cimzia(R) alone or in conjunction with immunosuppressive agents. Do not initiate treatment with Cimzia(R) in patients with active infections, including chronic or localized infections. Patients who develop a new infection while undergoing treatment with Cimzia(R) should be monitored closely. Discontinue administration of Cimzia(R) if a patient develops a serious infection. Exercise caution when considering the use of Cimzia(R) in patients with a history of recurrent infection, concomitant immunosuppressive therapy, or underlying conditions that may predispose them to infections, or patients who have resided in regions where tuberculosis and histoplasmosis are endemic.

Use of TNF blockers, including Cimzia(R), may increase the risk of reactivation of he
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