1st line treatment of patients w/ locally advanced (not amenable to curative therapy) or metastatic NSCLC who have activating mutations of the EGFR-TK.
Assess EGFR mutation status prior to treatment initiation. Do not use in patients w/ EGFR mutation -ve tumours. Reports of isolated cases of hepatic failure & fulminant hepatitis; GI perforation; haemoptysis/pulmonary haemorrhage; conjunctivitis, blepharitis, dry eye, corneal erosion & other ocular disorders; ILD. Associated w/ diarrhea, nausea, vomiting, stomatitis, & anorexia; epistaxis, haematuria; rash. May have phototoxicity potential. Concomitant use w/ drugs that cause significant elevation in gastric pH; CYP3A4 inducers or inhibitors; CYP2D6 substrates, especially those w/ narrow therapeutic index; warfarin; vinorelbine. Electrolytes, BUN, creatinine, liver function tests (ALT, AST, bilirubin) should be performed at baseline & periodically during therapy. Regularly monitor for changes in prothrombin time or INR in patients concomitantly taking warfarin. Patients w/ severe renal impairment; moderate or severe hepatic impairment; poor CYP2D6 metabolisers. Advise women of childbearing potential to avoid becoming pregnant. May cause fetal harm when administered to a pregnant woman. Women should be advised against breast-feeding during therapy. Not indicated for use in paed patients.
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