Zuellig Pharma
Concise Prescribing Info
Adults w/ locally advanced or metastatic non-small cell lung cancer w/ activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).
Dosage/Direction for Use
May be taken with or without food: May also be dispersed in ½ glass of plain, non-carbonated water. No other liqd should be used. Drop the tab in water & stir w/o crushing until it disperses (approx 15 min). Drink immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via nasogastric tube.
Special Precautions
Discontinue use if interstitial lung disease, ulcerative keratitis is confirmed. Cerebrovascular events; severe or persistent diarrhoea, nausea, vomiting or anorexia; keratitis; GI perforation or ulceration, bowel metastases at perforation site; smoking. Assess EGFR mutation of tumour tissue prior to treatment. Periodically monitor liver function. Regularly monitor prothrombin time or INR changes in patients taking warfarin. Concomitant use w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort; drugs causing significant sustained gastric pH elevations; vinorelbine; steroids or NSAIDs. May affect ability to drive & use machines. Mild to moderate hepatic function changes. Women of childbearing potential should use effective contraception. Not to be used during pregnancy & lactation. Not recommended in childn or adolescents. Elderly.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausea, stomatitis; elevated ALT; pustular rash including skin fissures; asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage eg, epistaxis, haematuria; interstitial lung disease; dehydration, dry mouth; elevated AST & total bilirubin; nail disorder, alopecia, allergic reactions eg, angioedema, urticaria; asymptomatic laboratory elevations in blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Reduced mean AUC w/ rifampicin, ranitidine. Increased mean AUC w/ itraconazole. Elevated INR &/or bleeding events w/ warfarin. Reduced efficacy w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort. Exacerbated neutropenic effect of vinorelbine.
ATC Classification
L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Iressa FC tab 250 mg
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