Erlotinib Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions, which may include fatalities, are discussed in greater detail in other sections of the labeling: Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.1) ] Renal Failure [see Warnings and Precautions (5.2) ] Hepatotoxicity with or without Hepatic Impairment [see Warnings and Precautions (5.3) ] Gastrointestinal Perforation [see Warnings and Precautions (5.4) ] Bullous and Exfoliative Skin Disorders [see Warnings and Precautions (5.5) ] Cerebrovascular Accident [see Warnings and Precautions (5.6) ] Microangiopathic Hemolytic Anemia with Thrombocytopenia [see Warnings and Precautions (5.7) ] Ocular Disorders [see Warnings and Precautions (5.8) ] Hemorrhage in Patients Taking Warfarin [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥20%) with erlotinib tablets from a pooled analysis in patients with NSCLC across all approved lines of therapy, with and without EGFR mutations, and in patients with pancreatic cancer were rash, diarrhea, anorexia, fatigue, dyspnea, cough, nausea, and vomiting.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact 1-888-557-1212 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch 6.1 Clinical Trials Safety 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.

Safety evaluation of erlotinib tablet is based on more than 1200 cancer patients who received erlotinib tablet as monotherapy, more than 300 patients who received erlotinib tablet 100 or 150 mg plus gemcitabine, and 1228 patients who received erlotinib tablet concurrently with other chemotherapies.

The most common adverse reactions with erlotinib tablet are rash and diarrhea usually with onset during the first month of treatment.

The incidences of rash and diarrhea from clinical studies of erlotinib tablet for the treatment of NSCLC and pancreatic cancer were 70% for rash and 42% for diarrhea.

Non-Small Cell Lung Cancer First-Line Treatment of Patients with EGFR Mutations The most frequent (≥ 30%) adverse reactions in erlotinib tablets-treated patients were diarrhea, asthenia, rash, cough, dyspnea, and decreased appetite.

In erlotinib tablets-treated patients the median time to onset of rash was 15 days and the median time to onset of diarrhea was 32 days.

The most frequent Grade 3-4 adverse reactions in erlotinib tablets-treated patients were rash and diarrhea.

Dose interruptions or reductions due to adverse reactions occurred in 37% of erlotinib tabletstreated patients, and 14.3% of erlotinib tablets-treated patients discontinued therapy due to adverse reactions.

In erlotinib tablets-treated patients, the most frequently reported adverse reactions leading to dose modification were rash (13%), diarrhea (10%), and asthenia (3.6%).