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UCB's Cimzia(R) (certolizumab pegol), Shows Rapid and Sustained Clinical Response in Adult Patients Living with Moderate to Severe Rheumatoid Arthritis
Date:10/17/2009

anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness .
  • Bacterial, viral and other infections due to opportunistic pathogens.
  • The risks and benefits of treatment with Cimzia® should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Cimzia®, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

    Serious and sometimes fatal infection due to bacterial, mycobacterial, invasive fungal, viral or other opportunistic pathogens has been reported in patients receiving TNF-blocking agents. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, and pneumocystosis were the most common. Treatment with Cimzia® should not be initiated in patients with an active infection, including clinically important localized infections. Cimzia® should be discontinued if a patient develops a serious infection or sepsis. Patients who develop a new infection during treatment with Cimzia® should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for immunocompromised patients, and appropriate antimicrobial therapy should be initiated. Appropriate empiric antifungal therapy should also be considered while a diagnostic workup is performed for patients who develop a serious systemic illness and reside or travel in regions where mycoses are endemic.

    Malignancies

    During controlled and open-labeled portions of Cimzia® studies of Crohn's disease and other diseases, malignancies (
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