Zydelig Side Effects

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling.

Hepatotoxicity [see Warnings and Precautions (5.1) ] Severe Diarrhea or Colitis [see Warnings and Precautions (5.2) ] Pneumonitis [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Intestinal Perforation [see Warnings and Precautions (5.5) ] Severe Cutaneous Reactions [see Warnings and Precautions (5.6) ] Hypersensitivity Reactions [see Warnings and Precautions (5.7) ] Neutropenia [see Warnings and Precautions (5.8) ] The most common adverse reactions (incidence ≥30%) in patients treated with Zydelig in combination trials are diarrhea, pneumonia, pyrexia, fatigue, rash, cough, and nausea.

( 6.1 ) Common laboratory abnormalities are neutropenia, ALT elevations and AST elevations.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc.

at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The pooled safety population described in the WARNINGS AND PRECAUTIONS reflect exposure to Zydelig at a dosage of 150 mg twice daily in 110 patients administered in combination with rituximab in Study 312-0116, and in combination with other drugs in 380 patients.

Among 490 patients who received Zydelig, 74% were exposed for 6 months or longer and 50% were exposed for one year or longer.

In this pooled safety population, the most common (> 30%) adverse reactions were diarrhea, pneumonia, pyrexia, fatigue, rash, cough, and nausea.

Common laboratory abnormalities were neutropenia, ALT elevations and AST elevations.