Type:Tablet
Generic Name:Gefitinib
Manufacturer:Drug International Ltd.
Price:৳250.00
Non-small Cell Lung Cancer
Film-coated tab: 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 10 min). Drink immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via NG tube.
Oral Locally advanced or metastatic non-small cell lung carcinoma Adult: 250 mg once daily until disease progression or unacceptable toxicity
Hypersensitivity. Lactation.
Gefitinib is a synthetic anilinoquinazoline which inhibits the intracellular phosphorylation of numerous tyrosine kinases associated w/ transmembrane cell surface receptors found on both normal and cancer cells, including epidermal growth factor receptor (EGFR) tyrosine kinase. Tyrosine kinase activity appears to be essentially important to cell proliferation and survival.
Patients w/ concurrent idiopathic pulmonary fibrosis, acute onset or worsening pulmonary or eye symptoms. Renal and hepatic impairment. Pregnancy. Monitoring Parameters Monitor liver function, prothrombin time or INR frequently. Lactation Unknown if distributed in human breast milk; not recommended
>10% Skin reactions, all grades (47%),Diarrhea, all grades (29%),Decreased appetite, all grades (17%),Vomiting, all grades (14%),Increased ALT, all grades (11.4%) 1-10% Increased AST, all grades (7.9%),Stomatitis, all grades (7%),Conjunctivitis, blepharitis, and dry eye (6.7%),Conjunctivitis/blepharitis/dry eye (6%),Increased ALT, grades 3-4 (5.1%),Nail disorders, all grades (5%),Diarrhea, grades 3-4 (3%),Increased AST, grades 3-4 (3%),Increased bilirubin, all grades (2.7%),Decreased appetite, grades 2-3 (2.3%),Skin reactions, grades 3-4 (2%),Interstitial lung disease, all grades (1.3%),Vomiting, grades 3-4 (1.2%) <1% Interstitial lung disease, grades 3-4 (0.7%),Increased bilirubin, grades 3-4 (0.7%),Stomatitis, all grades (0.3%),Corneal erosion and aberrant eyelash growth (0.2%),Nail disorders, grades 3-4 (0.1%),Gastrointestinal perforation (0.1%),Ocular keratitis (0.1%),Erythema multiforme and dermatitis bullous (0.08%),Fatal hepatoxicity (0.04%)
Concomitant use w/ CYP3A4 inducers (e.g. rifampicin, phenytoin, carbamazepine, barbiturates) may reduce serum gefitinib levels. Plasma concentrations may be increased w/ potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole). Increased INR or bleeding events w/ warfarin. May increase plasma levels of metoprolol. May exacerbate vinorelbine-induced neutropenia. Decreased plasma levels and potential reduction in efficacy w/ drugs that affect gastric pH (e.g. PPIs, H2-receptor antagonists).
