International Med
Concise Prescribing Info
Monotherapy for the treatment of adults w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating mutations of EGFR-TK.
Dosage/Direction for Use
May be taken with or without food: Tab may be dispersed in ½ glass of non-carbonated drinking water. No other liqd should be used. Drop the tab in water & w/o crushing it, stir until dispersed (approx 20 min). Drink the liqd immediately. Rinse the glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via a nasogastric tube.
Special Precautions
Risk of interstitial lung disease (ILD); liver function test abnormalities; GI perforation. Patients presenting w/ signs & symptoms suggestive of keratitis should be referred promptly to an ophthalmology specialist. Patients should be advised to seek medical advice in case of severe or persistent diarrhoea, nausea, vomiting or anorexia. Avoid concomitant use w/ CYP3A4 inducers. Concomitant use w/ CYP3A4 inhibitor; warfarin; medicinal products that may cause sustained elevation in gastric pH (eg, proton pump inhibitors, H2 antagonists & antacids); vinorelbine. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Patients experiencing asthenia should be cautious when driving or using machines. Patients w/ hepatic impairment. Patients w/ CrCl ≤20 mL/min. Poor CYP2D6 metabolisers. Pregnancy. Women of childbearing potential must be advised not to get pregnant during therapy.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausea, stomatitis; ALT elevations; skin reactions; asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage; ILD; dehydration (secondary to diarrhoea, nausea, vomiting or anorexia), dry mouth; AST & total bilirubin elevations; nail disorder, alopecia, allergic reactions; asymptomatic blood creatinine elevations, proteinuria, cystitis; pyrexia.
Drug Interactions
Increased plasma conc w/ potent CYP3A4 inhibitors (eg, ketoconazole, posaconazole, voriconazole, PIs, clarithromycin, telithromycin); potent CYP2D6 inhibitors. Decreased plasma conc w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort). Reduced plasma conc w/ substances that cause significant sustained elevation in gastric pH (eg, proton pump inhibitors, H2-receptor antagonists, antacids). May alter plasma conc of CYP2D6 substrates w/ narrow therapeutic index. INR elevations &/or bleeding events w/ warfarin.
ATC Classification
L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Veiasu FC tab 250 mg
3 × 10's
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