Gafvex

Gafvex

gefitinib

Manufacturer:

Vexxa Lifesciences

Distributor:

VE Pharma
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
Locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating mutations of EGFR-TK in adult.
Dosage/Direction for Use
Administration
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. Take at about the same time each day.
Contraindications
Special Precautions
Avoid false -ve or +ve EGFR determinations. Discontinue if interstitial lung disease or ulcerative keratitis occurs. GI perforation. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Avoid concomitant use w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or herbal prep containing St. John's wort). Hepatoxicity & liver impairment. Childn & adolescent <18 yr.
Adverse Reactions
Anorexia; diarrhea, vomiting, nausea, stomatitis; elevation in alanine aminotransferase; skin reactions mainly pustular rash; fissures, asthenia. Conjunctivitis, blepharitis, dry eye; hemorrhage (eg, epistaxis & hematuria); interstitial lung disease; dehydration, dry mouth; elevation in aspartate aminotransferase & total bilirubin; nail disorder, alopecia; asymptomatic lab elevations in blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Increase metabolism & decrease plasma conc w/ rifampicin or phenytoin. INR elevations &/or bleeding events w/ warfarin. Decrease metabolism & increase plasma conc w/ ketoconazole & itraconazole. May reduce plasma conc w/ ranitidine & cimetidine. Reduced efficacy w/ phenytoin, carbamazepine, rifampicin, barbiturates, or herbal prep containing St. John's wort. Reduced bioavailability & plasma conc w/ PPIs. H2 antagonist & antacids. May exacerbate the neutropenic effect of vinorelbine.
ATC Classification
L01EB01 - gefitinib ; Belongs to the class of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Gafvex FC tab 250 mg
Packing/Price
30's
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