Gefitinib Alvogen

Gefitinib Alvogen





Zuellig Pharma
Concise Prescribing Info
1st-line treatment of patients w/ locally advanced or metastatic non-small cell lung cancer who have activating EGFR-TK mutations.
Dosage/Direction for Use
May be taken with or without food: Tab may be dispersed in ½ glass of non-carbonated drinking 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.
Special Precautions
Discontinue use if interstitial lung disease, ulcerative keratitis is confirmed. Severe or persistent diarrhoea, nausea, vomiting or anorexia; keratitis; CNS haemorrhages; GI perforation, underlying history of GI ulceration, smoking, bowel metastases at perforation sites. Assess EGFR mutation of tumour tissue prior to treatment. Periodically monitor liver function. Monitor patients w/ known CYP2D6 metaboliser genotype. Galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption. Concomitant use w/ CYP3A4 inducers & inhibitors, warfarin, proton-pump inhibitors, H2-antagonists, vinorelbine, steroids, NSAIDs. May affect ability to drive & use machines. Renal impairment (CrCl <20 mL/min). Moderate to severe hepatic impairment. Women of childbearing potential. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausea, stomatitis; elevated ALT; skin reactions; asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage; interstitial lung disease; dehydration, dry mouth; elevated AST, total bilirubin; nail disorder, alopecia, allergic reactions; elevated blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Increased plasma conc w/ CYP3A4 inhibitors eg, ketoconazole, posaconazole, voriconazole, itraconazole, PIs, clarithromycin, telithromycin; CYP2D6 inhibitors. Reduced plasma conc w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort (Hypericum perforatum); drugs causing gastric pH elevations eg, antacids, ranitidine; proton-pump inhibitors, H2-antagonists. Increased exposure to metoprolol. INR elevations &/or bleeding w/ warfarin. Exacerbated neutropenic effects of vinorelbine.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Gefitinib Alvogen FC tab 250 mg
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