Simponi (golimumab)

May 30, 2009

Audience: Rheumatological healthcare professionals

[Posted 05/27/2009] Centocor Ortho Biotech and FDA reminded healthcare professionals of the risk of serious fungal infections associated with TNF-α blockers, including Simponi [golimumab]. FDA has reported that histoplasmosis and other invasive fungal infections are not consistently recognized in patients taking other TNF-α blockers including Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab). This has resulted in delays in appropriate antifungal treatment, sometimes even resulting in death. It is important that all adverse events potentially associated with Simponi be reported so that the adverse event profile reported in the prescribing information can be updated appropriately as post-approval experience is gathered. Centocor encourages reporting adverse events to Centocor at 1-800-457-6399 or to the FDA MedWatch program at 1-800-332-1088.

[May 2009 - Dear Healthcare Professional Letter - Centocor]
[April 2009 - Prescribing Information and Medication Guide - Simponi (golimumab) - Centocor

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