Zuellig Pharma
Concise Prescribing Info
Locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating mutations of the EGFR TK.
Dosage/Direction for Use
May be taken with or without food: For patients w/ swallowing difficulties, drop tab in ½ glass of non-carbonated drinking water & stir until tab disperses (approx 15 min), do not crush. Drink immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via a nasogastric tube.
Special Precautions
EGFR mutation assessment of the tumour tissue is recommended in 1st-line treatment for advanced or metastatic NSCLC. Not to be used in preference to doublet chemotherapy in mutation-negative patients in 1st-line setting. Interrupt & initiate prompt investigation if patients present w/ worsening of resp symptoms (eg, dyspnoea, cough & fever). Discontinue use & treat patient appropriately if interstitial lung disease (ILD) is confirmed. Perform periodic liver function test; consider discontinuation if changes are severe. Possible cerebrovascular events. Concomitant use w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort); drugs causing significant sustained elevation in gastric pH. Regularly monitor changes in prothrombin time or INR in patients taking warfarin. Seek medical advice in the event of developing severe or persistent diarrhoea, nausea, vomiting or anorexia. Promptly refer to an ophthalmologist if patient presents w/ signs & symptoms suggestive of keratitis (eg, acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye). History of keratitis, ulcerative keratitis or severe dry eye. Possible CNS haemorrhages. May exacerbate neutropenic effect of vinorelbine. Possible GI perforation associated w/ other known risk factors including increasing age, concomitant use of steroids or NSAIDs, underlying history of GI ulceration, smoking or bowel metastases at sites of perforation. Possible asthenia during treatment & when driving or using machines. Women of childbearing potential must be advised to avoid becoming pregnant. Pregnancy. Recommend to discontinue nursing while receiving therapy. Not recommended for use in childn or adolescents.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausea, stomatitis; elevated ALT; skin reactions (eg, pustular rash, itchy w/ dry skin including skin fissures on an erythematous base); asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage (eg, epistaxis & haematuria); ILD; dehydration, dry mouth; elevated AST & total bilirubin; nail disorder, alopecia, allergic reactions including angioedema & urticaria; asymptomatic elevated blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Reduced mean AUC w/ rifampicin & ranitidine. Increased mean AUC w/ itraconazole, & other CYP3A4 inhbitors (eg, ketoconazole, clotrimazole, ritonavir). Risk of elevated INR &/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.
Iressa FC tab 250 mg
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