Gefitinib Teva

Gefitinib Teva



Teva Pharma


Concise Prescribing Info
As monotherapy for adults w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).
Dosage/Direction for Use
May be taken with or without food: Take approx at the same time each day. Swallow whole w/ water. For patients w/ swallowing difficulties, disperse tab in ½ glass non-carbonated drinking water. No other liqd should be used. Drop the tab in ½ glass 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
Attempt EGFR mutation assessment of tumour tissue. Interrupt treatment if worsening of resp symptoms eg, dyspnoea, cough & fever is experienced & confirmed ulcerative keratitis. Discontinue treatment in confirmed interstitial lung disease (ILD). Periodic liver function testing is recommended; discontinue if changes are severe. Impaired liver function due to cirrhosis. Avoid concomitant use w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or herbal prep containing St. John's wort/Hypericum perforatum; warfarin; medicines that cause significant sustained elevation in gastric pH eg, proton-pump inhibitors & H2-antagonists. Galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Severe or persistent diarrhoea, nausea, vomiting or anorexia that may indirectly lead to dehydration; signs & symptoms suggestive of keratitis. Increased risk of cerebral haemorrhage; GI perforation. May impair ability to drive & use machines. Moderate to severe hepatic impairment (Child-Pugh B or C). Renal impairment (CrCl ≤20 mL/min). Pregnancy. Contraindicated in breastfeeding. Paed patients <18 yr.
Adverse Reactions
Mild or moderate anorexia; mild or moderate diarrhoea; mild to moderate elevated ALT; skin reactions, mild or moderate pustular rash, sometimes itchy w/ dry skin, including skin fissures, on an erythematous base; predominantly mild asthenia. Mainly mild conjunctivitis, blepharitis, & dry eye; haemorrhage eg, epistaxis & haematuria; often severe ILD; mainly mild or moderate vomiting, mainly mild nausea, predominantly mild stomatitis, dehydration, secondary to diarrhoea, nausea, vomiting or anorexia, predominantly mild dry mouth; mild to moderate elevated AST & total bilirubin; nail disorder; asymptomatic lab elevated blood creatinine, proteinuria; pyrexia. Toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Drug Interactions
May have increased plasma conc w/ potent CYP3A4 inhibitors (eg, ketoconazole, posaconazole, voriconazole, PIs, clarithromycin, telithromycin) & potent CYP2D6 inhibitors. May have increased metabolism & decreased plasma conc w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or St John's wort, Hypericum perforatum). May reduce plasma conc w/ substances that cause gastric pH elevation (ie, short-acting antacids). Reduced mean area under the curve (AUC) w/ ranitidine. Increased exposure w/ metoprolol. INR elevations &/or bleeding events w/ warfarin.
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 Teva FC tab 250 mg
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