Gafvex

Gefitinib

Locally advanced or metastatic NSCLC w/ activating mutations of EGFR-TK in adult.

1 tab once daily taken at about the same time each day.

May be taken with or without food: Tab may be dispersed in ½ glass of non-carbonated 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.

Hypersensitivity.

Avoid false -ve or +ve EGFR determinations. Discontinue if patients experience worsening of resp symptoms eg, dyspnoea, cough & fever or ILD is confirmed. Patients w/ CT scan evidence of reduced normal lung, pre-existing ILD, & extensive areas adherent to pleura. Periodic LFT is recommended. Impaired liver function due to cirrhosis may occur. Patients w/ rare hereditary problems of galactose intolerance, the Lapp lactose deficiency or glucose-galactose malabsorption. Severe or persistent diarrhoea, nausea, vomiting or anorexia. Interrupt therapy if a diagnosis of ulcerative keratitis is confirmed or symptoms recur on reintroduction permanently discontinue. Increased risk of cerebral haemorrhage in adult patients w/ NSCLC. GI perforation; underlying history of GI ulceration, smoking or bowel metastases at sites of perforation. Concomitant use w/ antacids, PPIs & H₂-antagonists. Avoid concomitant use w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or herbal prep containing St. John's wort). Moderate to severe hepatic impairment (Child Pugh B or C). Patients w/ CrCl 20 mL/min. Childn & adolescent <18 yr.

Anorexia; diarrhea, vomiting, nausea, stomatitis; ALT elevation; skin reactions particularly pustular rash sometimes itchy w/ dry skin, including skin fissures, on erythematous base; asthenia. Conjunctivitis, blepharitis, dry eye; hemorrhage (eg, epistaxis & hematuria); ILD; dehydration, dry mouth; AST & total bilirubin elevation; nail disorder, alopecia; asymptomatic lab elevations in blood creatinine, proteinuria, cystitis; pyrexia.

Increased metabolism & decreased plasma conc w/ potent CYP3A4 inducer (eg, phenytoin, carbamazepine, rifampicin, barbiturates or herbal prep containing St. John's wort). INR elevations &/or bleeding events w/ warfarin. Decreased metabolism & increased plasma conc w/ potent CYP3A4 inhibitors eg, ketoconazole & itraconazole. May reduce plasma conc w/ histamine H₂-receptor antagonist eg, ranitidine & cimetidine. Reduced efficacy w/ phenytoin, carbamazepine, rifampicin, barbiturates, or herbal prep containing St. John's wort. Reduced bioavailability & plasma conc w/ PPIs & antacids. May exacerbate the neutropenic effect of vinorelbine.

Targeted Cancer Therapy

L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.

Rx