Interrupt therapy in patients who develop acute onset of new &/or progressive unexplained pulmonary symptoms eg, dyspnoea, cough & fever; in severe or persistent diarrhoea, nausea, anorexia, or vomiting associated w/ dehydration; w/ aggravating risk factors especially concomitant chemotherapy & other medications, symptoms or diseases or other predisposing conditions including advanced age; if changes in liver function are severe. Discontinue treatment if ILD is diagnosed. Permanently discontinue treatment in patients who develop GI perforation. Interrupt or discontinue treatment if patient develops severe bullous, blistering or exfoliating conditions; if diagnosis of ulcerative keratitis is confirmed. Determine EGFR mutation status when considering to use treatment as 1st line or maintenance treatment for locally advanced or metastatic NSCLC. Increased risk of developing GI perforation. SJS, TEN. Corneal perforation or ulceration. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, &/or taxane based chemotherapy, or who have prior history of peptic ulceration or diverticular disease; w/ history of keratitis, ulcerative keratitis or severe dry eye. Contact lens use. Advise current smokers to stop smoking. Monitor for possibility to develop ILD-like toxicity in patients treated concurrently w/ gemcitabine. Monitor renal function & serum electrolytes including K in patients at risk of dehydration. Consider periodic liver function testing in patients w/ pre-existing liver disease or concomitant hepatotoxic medications. Perform testing for skin infection in patients w/ bullous & exfoliative skin disorders. Promptly refer to ophthalmology specialist the patients presenting w/ signs & symptoms suggestive of keratitis eg, acute or worsening (eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye). Consider to administer antacids at least 4 hr before or 2 hr after daily dose if necessary during treatment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use w/ potent CYP3A4 inducers & inhibitors; medicinal products altering pH of upper GIT eg, PPIs, H
2 antagonists & antacids. Hepatic & severe renal (serum creatinine conc >1.5x ULN) impairment. Not recommended in severe hepatic dysfunction. Women of childbearing potential should avoid pregnancy while on therapy; use adequate contraceptive methods during, & for at least 2 wk after completing therapy. Pregnancy. Advise mothers not to breastfeed while on therapy & at least 2 wk after final dose. Not recommended in paed <18 yr.
Sign Out
