1st-line treatment of patients w/ locally advanced or metastatic NSCLC who have activating mutations of EGFR-TK. Locally advanced or metastatic NSCLC in patients who have previously received chemotherapy.
May be taken with or without food: Take at approx the same time each day w/ water. For patients w/ difficulty swallowing, tab may be dispersed in ½ glass of non-carbonated drinking water. No other liqd should be used. Drop the tab in water & w/o crushing it, swirl glass occasionally until tab is dispersed (approx 20 min). Drink the liqd immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via nasogastric or gastrostomy tube.
Discontinue use if ILD; ulcerative keratitis is confirmed. Cerebral haemorrhage; severe or persistent diarrhoea, nausea, vomiting or anorexia; keratitis; GI perforation or ulceration, bowel metastases at perforation site; smoking. Assess EGFR mutation of tumour tissue prior to treatment. Periodically monitor liver function. Regularly monitor prothrombin time or INR changes in patients taking warfarin. Concomitant use w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort; drugs causing significant sustained gastric pH elevations eg, PPIs, H2-antagonists; vinorelbine; steroids or NSAIDs. May affect ability to drive & use machines. Mild to moderate hepatic function changes. Women of childbearing potential. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr. Elderly.
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