Locally advanced or metastatic NSCLC w/ epidermal growth factor receptor (EGFR) mutations. Locally advanced or metastatic NSCLC of squamous histology progressing on or after platinum-based chemotherapy.
Patient w/ EGFR mutation +ve NSCLC not previously treated w/ EGFR tyrosine kinase inhibitor (TKI) 40 mg once daily. Dose escalation to a max of 50 mg/day may be considered in those who tolerate a 40 mg/day in the 1st treatment cycle. Patient w/ EGFR mutation +ve NSCLC previously treated w/ EGFR TKI 50 mg once daily. Patient w/ squamous NSCLC who have previously received 1st-time platinum regimen 40 mg once daily.
View Giotrif overdosage for action to be taken in the event of an overdose.
Administration
Should be taken on an empty stomach: Take at least 1 hr before or 3 hr after meals. Swallow whole. For patients w/ swallowing difficulties, disperse tab in 100 mL plain, non-carbonated water. Do not use other liqd. Stir w/o crushing until it disperses (approx 15 min) then, drink immediately. Rinse glass w/ another 100 mL water & drink. Mixt may also be administered via a nasogastric tube.
Assess EGFR mutation status. Proactive management of diarrhoea including adequate hydration combined w/ anti-diarrhoeal agents especially w/in the 1st 6 wk of treatment & at 1st signs of diarrhoea. Mild or moderate erythematous & acneiform rash may occur or worsen in areas exposed to sun. Interrupt or discontinue treatment if severe bullous, blistering or exfoliating conditions occur. Close monitoring in female patients, patients w/ lower body wt & those w/ underlying renal impairment. Perform careful assessment of patients w/ acute onset &/or unexplained worsening of pulmonary symptoms (dyspnoea, cough, fever) to exclude ILD. Periodic LFT in patients w/ preexisting liver disease; discontinue if severe hepatic impairment develops. Permanently discontinue if ILD is diagnosed; GI perforation develops. History of keratitis, ulcerative keratitis or severe dry eye. Consider cardiac monitoring including left ventricular ejection fraction (LVEF) assessment at baseline & during treatment in patients w/ cardiac risk factors & those w/ conditions that can affect LVEF. Consider treatment interruption or discontinuation in patients w/ ejection fraction below the institution's LLN. Concomitant use w/ strong P-gp inhibitors/inducers. Not recommended in patients w/ Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ eGFR <15 mL/min or on dialysis. Women of childbearing potential should use adequate contraceptive methods during therapy & for at least 2 wk after the last dose. Pregnancy & lactation. Not recommended in childn or adolescents.
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