1st-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ epidermal growth factor receptor (EGFR) activating mutations. Monotherapy for maintenance treatment of locally advanced or metastatic NSCLC w/ stable disease after 4 cycles of standard platinum-based 1st-line chemotherapy. Treatment of locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. In combination w/ gemcitabine, indicated for metastatic pancreatic cancer.
Dosage/Direction for Use
NSCLC 150 mg once daily. Pancreatic cancer 100 mg once daily.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 2 hr after meals.
Special Precautions
Interstitial lung disease, severe or persistent diarrhoea, nausea, anorexia or vomiting, associated w/ dehydration. Perform periodic liver function testing; GI perforation, severe bullous, blistering or exfoliating conditions. Acute/worsening ocular disorders. Concomitant w/ CYP3A4 substrates & modulators. Hepatic & severe renal impairment. Cigarette smoking. Pregnancy & lactation. Childn <18 yr.
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