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Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
- ...Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with ILARIS. Generally, the observed infections responded to standard therapy. Isolated cases of unusual or opportunistic infections (e.g., aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster) were reported during ILARIS treatment. A causal relationship of ILARIS to these events cannot be excluded. In clinical trials, ILARIS has not been administered concomitantly with tumor necrosis factor (TNF) inhibitors. An increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors. Coadministration of ILARIS with TNF inhibitors is not recommended because this may increase the risk of serious infections [see Drug Interactions (7.1)].
What are the possible side effects of Ilaris?
- Decrease in white blood cells (neutropenia) which help your body fight infections