Fatal and Serious Toxicities: Infections, Diarrhea or Colitis, Cutaneous Reactions, and Pneumonitis

Infections

• Fatal and/or serious infections occurred in 31% of COPIKTRAtreated patients. Monitor for signs and symptoms of infection. Withhold COPIKTRA if infection is suspected.

Diarrhea or Colitis

• Fatal and/or serious diarrhea or colitis occurred in 18% of COPIKTRA-treated patients. Monitor for the development of severe diarrhea or colitis. Withhold COPIKTRA.

Cutaneous Reactions

• Fatal and/or serious cutaneous reactions occurred in 5% of COPIKTRA-treated patients. Withhold COPIKTRA.

Pneumonitis

• Fatal and/or serious pneumonitis occurred in 5% of COPIKTRAtreated patients. Monitor for pulmonary symptoms and interstitial infiltrates. Withhold COPIKTRA