Discontinue permanently if ILD is diagnosed; in patients who develop QTc interval prolongation in combination w/ Torsade de Pointes, polymorphic ventricular tachycardia, signs/symptoms of serious arrhythmia. Discontinue use if signs & symptoms suggestive of SJS appear; in patients w/ confirmed aplastic anaemia. Consider drug interruption or discontinuation if signs & symptoms suggestive of erythema multiforme or aplastic anaemia develop. Withhold treatment in patients who develop QTc interval of >500 msec on at least 2 separate ECGs until QTc interval is <481 msec or recovery to baseline if the QTc interval is ≥481 msec, then resume treatment at reduced dose. Severe, life-threatening or fatal ILD or ILD-like adverse reactions. Keratitis. Avoid use in patients w/ congenital long QT syndrome. Patients w/ body wt <50 kg. Determine EGFR mutation +ve status. Perform careful assessment of all patients w/ acute onset &/or unexplained worsening of pulmonary symptoms eg, dyspnoea, cough & fever to exclude ILD. Advise patients of signs & symptoms of erythema multiforme, SJS or aplastic anaemia prior to treatment. Periodically monitor ECGs & electrolytes in patients w/ CHF, electrolyte abnormalities or those taking QTC interval prolonging medicinal products. Cardiac monitoring & LVEF assessment in patients who develop relevant cardiac signs/symptoms during treatment. Not recommended in severe hepatic impairment. Severe renal impairment & ESRD patients (CrCl <15 mL/min) or on dialysis. Patients of childbearing potential should use effective contraception at least 2 mth after treatment completion for females & at least 4 mth after treatment completion for males. Not to be used during pregnancy. Discontinue lactation during treatment. Childn or adolescents <18 yr. Elderly (>65 yr).
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