Precaution
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
Side Effect
>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%)
Interaction
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).