Iressa益患適

Iressa

gefitinib

Manufacturer:

AstraZeneca

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
Monotherapy for the treatment of 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
Administration
May be taken with or without food: 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 tube.
Contraindications
Special Precautions
Perform EGFR mutation assessment prior to treatment. Interstitial lung disease; worsening of resp symptoms. Liver function test abnormalities. GI perforation. Concomitant use w/ CYP3A4 inducers; drugs that cause significant sustained elevation in gastric pH; warfarin; vinorelbine. Patients presenting w/ signs & symptoms suggestive of keratitis should be referred promptly to ophth specialist. Moderate to severe hepatic impairment (Child-Pugh B or C) due to cirrhosis; CrCl ≤20 mL/min; known CYP2D6 poor metaboliser. May impair ability to drive & use machines. Pregnancy & lactation.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausua, stomatitis; elevations in ALT; skin reactions (eg, pustular rash, sometimes itchy w/ dry skin, including skin fissures); asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage eg, epistaxis & haematuria; interstitial lung disease; dehydration, dry mouth; elevations in AST & total bilirubin; nail disorder, alopecia, allergic reactions (eg, angioedema, urticaria); asymptomatic laboratory elevations in blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Reduced mean AUC w/ rifampicin (known potent CYP3A4 inducer); drugs that cause sustained elevations in gastric pH (pH ≥5). Increased mean AUC w/ itraconazole (CYP3A4 inhibitor). Reports of INR elevations &/or bleeding events w/ warfarin. May exacerbate neutropenic effect 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.
Presentation/Packing
Form
Iressa FC tab 250 mg
Packing/Price
30's
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