Gefitinib Sandoz

Gefitinib

Monotherapy for locally advanced or metastatic NSCLC w/ activating mutations of EGFR-TK in adults.

1 tab once daily.

May be taken with or without food: Swallow whole w/ some water, or administer as dispersion in non-carbonated water if dosing of whole tab is not possible. No other liqd should be used. Do not crush tab. Drop tab in ½ glass of drinking water, then occasionally swirl until dispersed. Immediately drink after dispersion is complete (ie, w/in 60 min). Rinse glass w/ ½ glass of water, then drink. Dispersion can also be administered through a naso-gastric or gastrostomy tube.

Hypersensitivity. Lactation.

Assess EGFR mutation status before starting treatment. Risk of ILD; LFT abnormalities (including increases in ALT, AST, bilirubin); severe or persistent diarrhoea, nausea, vomiting or anorexia; ulcerative keratitis; GI perforation. Avoid w/ CYP3A4 inducers. Caution w/ potent CYP3A4 inhibitors; warfarin; PPIs, H₂ antagonists, antacids. May exacerbate neutropenic effect of vinorelbine. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. May impair ability to drive or operate machinery. Caution in CYP2D6 poor metabolisers; patients w/ CrCl ≤20 mL/min. Increased plasma conc in patients w/ moderate to severe hepatic impairment (Child-Pugh B or C). Women of childbearing potential must be advised not to get pregnant during therapy. Should not be used during pregnancy unless clearly necessary. No relevant use in childn & adolescents <18 yr.

Anorexia; diarrhoea, vomiting, nausea, stomatitis; elevated ALT; skin reactions; asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage; ILD; dehydration, dry mouth; elevated AST & total bilirubin; nail disorder, alopecia, allergic reactions; asymptomatic lab elevations in blood creatinine, proteinuria, cystitis; pyrexia.

Increased plasma conc w/ potent CYP3A4 inhibitors (eg, ketoconazole, posaconazole, voriconazole, itraconazole, PIs, clarithromycin, telithromycin); potent CYP2D6 inhibitors. Decreased plasma conc w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates, St. John's wort); substances that cause significant sustained elevation in gastric pH (eg, antacids, ranitidine). Potentially relevant increase in exposure to CYP2D6 substrates w/ narrow therapeutic index. Reports of INR elevations &/or bleeding events in some patients concomitantly taking warfarin.

Targeted Cancer Therapy

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

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