.png?width=200&height=94&name=PDR_stacked_purple%20(002).png)
FDA Date: 1/4/17
Zydelig (idelalisib) Tablets REMS
Goals of the Zydelig (idelalisib) Tablets REMS Program
The goal of the Zydelig REMS is to mitigate the risks of fatal and/or serious hepatotoxicity, fatal and/or serious and severe diarrhea or colitis, fatal and serious pneumonitis, and fatal and/or serious infections, and fatal and serious intestinal perforation associated with Zydelig treatment by informing prescribers of the risks of
- fatal and/or serious hepatotoxicity
- fatal and/or serious and severe diarrhea or colitis
- fatal and serious pneumonitis
- fatal and/or serious infections
- fatal and serious intestinal perforation
REMS Elements• Communication Plan