Gefitero

Gefitero

gefitinib

Manufacturer:

Amarox
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
Naive treatment of patients w/ locally advanced or metastatic non-small cell lung cancer (NSCLC) w/ activating mutations of the EGFR TK, or those who have previously received chemotherapy or who are not suitable for chemotherapy.
Dosage/Direction for Use
Administration
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.
Contraindications
Special Precautions
EGFR mutation assessment of the tumour tissue is attempted for all patients. Interstitial lung disease. Patients w/ concurrent idiopathic pulmonary fibrosis/interstitial pneumonia/pneumoconiosis/radiation pneumonia/drug-induced pneumonia. Discontinue treatment if ILD is confirmed; severe changes in liver function. Liver function abnormalities. Periodic liver function tests is recommended. Co-administration w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort). Monitor patients taking warfarin for changes in prothrombin time or INR. Advise patient to seek immediate medical advice in the event of developing severe or persistent diarrhea, nausea, vomiting or anorexia. Keratitis should be referred promptly to ophth specialist & treatment interrupted if confirmed. May exacerbate the neutropenic effect of Vinorelbine. GI perforation. May impair ability to drive or use machinery due to asthenia. Women of childbearing potential must avoid becoming pregnant. Pregnancy & lactation. Not recommended in childn & adolescents.
Adverse Reactions
Anorexia; diarrhea, vomiting, nausea, stomatitis; elevated ALT; skin reactions, pustular rash (sometimes itchy w/ dry skin including skin fissures on erythematous base); asthenia. Conjunctivitis, blepharitis, dry eye; hemorrhage, epistaxis, hematuria; interstitial lung disease; dehydration, dry mouth; elevated AST & total bilirubin; nail disorder, alopecia, allergic reactions, angioedema & urticaria; asymptomatic laboratory elevations in blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Reduced mean AUC w/ rifampicin (potent CYP3A4 inducer), ranitidine. Increased mean AUC w/ itraconazole (CYP3A4 inhibitor). INR elevations &/or bleeding w/ warfarin.
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
Gefitero FC tab 250 mg
Packing/Price
3 × 10's
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