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