Iressa益患適

Iressa

gefitinib

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
Monotherapy for the treatment of adults w/ locally advanced or metastatic NSCLC w/ activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).
Dosage/Direction for Use
Administration
May be taken with or without food: Swallow whole, or disperse tab in ½ glass of non-carbonated drinking water & stir w/o crushing then, drink immediately. Rinse glass w/ ½ glass of water & drink. Mixt may also be given via a nasogastric or gastrostomy tube.
Contraindications
Special Precautions
Assess EGFR mutation when considering gefitinib. Monitor liver function, prothrombin time or INR. Discontinue in ILD; severe changes in liver function; ulcerative keratitis. Caution in patients w/ mild to moderate changes in liver function. Interrupt therapy for up to 14 days in patients w/ poorly tolerated diarrhoea or skin adverse drug reactions. May impair ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Anorexia; conjunctivitis; blepharitis; dry eye; haemorrhage; ILD; diarrhoea; vomiting; nausea; stomatitis; dehydration; dry mouth; elevations in ALT, AST, creatinine, & total bilirubin; skin reactions; nail disorder; alopecia; allergic reactions; proteinuria; cystitis; asthenia; pyrexia.
Drug Interactions
Decrease plasma conc w/ CYP3A4 inducers (eg, rifampicin, phenytoin, carbamazepine, barbiturates or herbal prep containing St. John's wort/Hypericum perforatum). Increase plasma levels of gefitinib in patients w/ CYP2D6 poor metaboliser genotype. Reduced mean AUC w/ drugs that increase gastric pH (eg, ranitidine). Reports of INR elevations &/or bleeding events w/ warfarin. Increased plasma levels w/ CYP3A4 inhibitors; potent CYP2D6 inhibitors.
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.
Presentation/Packing
Form
Iressa FC tab 250 mg
Packing/Price
30's
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