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Fatal and Serious Toxicities; Hepatic, Severe Diarrhea, Colitis, Pneumonitis, and Intestinal Perforation

  • Fatal and/or serious hepatotoxicity occurred in 16% to 18% of Zydelig-treated patients. Monitor hepatic function prior to and during treatment. Interrupt and then reduce or discontinue Zydelig as recommended
  • Fatal and/or serious and severe diarrhea or colitis occurred in 14% to 20% of Zydelig-treated patients. Monitor for the development of severe diarrhea or colitis. Interrupt and then reduce or discontinue Zydelig as recommended¬†
  • Fatal and serious pneumonitis can occur in Zydelig-treated patients. Monitor for pulmonary symptoms and bilateral interstitial infiltrates. Interrupt or discontinue Zydelig as recommended
  • Fatal and serious intestinal perforation can occur in Zydelig-treated patients across clinical trials. Discontinue Zydelig for intestinal perforation
  • Fatal and/or Serious infections occurred in 21% to 48% of Zydelig treated patients

Approved Risk Evaluation and Mitigation Strategies (REMS)

ZYDELIG (Idelalisib) Tablet, Film-Coated

Patient Counseling Information

Medication Guides

Patient Medication Guide

Package Inserts


Updated June 2018