Interrupt & reduce dose or discontinue treatment in patients w/ severe diarrhoea, develops severe bullous, blistering or exfoliating conditions, ulcerative keratitis. Female gender, lower body wt & underlying renal impairment. Permanently discontinue if interstitial lung disease is diagnosed. Worsening of liver function or severe hepatic impairment. GI perforation. Acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye. Cardiac monitoring including left ventricular function assessment in patients w/ cardiac risk factor; P-glycoprotein interactions; galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation.