Drug Safety Warnings and Updates: January-March 2018

Shannon Thor, PharmD, MS

Disclosures

May 23, 2018

Editorial Collaboration

Medscape &

In This Article

Idelalisib (Zydelig)

For more on this Drug Safety Labeling Change, click here.

For full prescribing information, click here.

Updated Boxed Warning

WARNING: FATAL AND SERIOUS TOXICITIES: HEPATIC, SEVERE DIARRHEA, COLITIS, PNEUMONITIS, INFECTIONS, and INTESTINAL PERFORATION

Fatal and/or serious hepatotoxicity occurred in 16%-18% of Zydelig-treated patients.

Fatal and/or serious and severe diarrhea or colitis occurred in 14% to 20% of Zydelig-treated patients.

Fatal and/or serious infections occurred in 21% to 48% of Zydelig-treated patients.

Comments

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