Iressa

Iressa

gefitinib

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Gefitinib
Indications/Uses
Locally advanced or metastatic NSCLC w/ activating mutations of EGFR TK.
Dosage/Direction for Use
Recommended dose: 250 mg once daily. Patient w/ poorly tolerated diarrhoea or skin adverse drug reactions Brief (up to 14 days) therapy interruption followed by reinstatement of 250 mg dose.
Administration
May be taken with or without food: For patients w/ swallowing difficulties, drop tab in ½ glass of non-carbonated drinking water & stir until tab disperses (approx 15 min), do not crush. Drink immediately. Rinse 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 recommended in 1st-line treatment for advanced or metastatic NSCLC. Not to be used in preference to doublet chemotherapy in mutation -ve patients in 1st-line setting. Interrupt treatment & initiate prompt investigation if patients present w/ worsening of resp symptoms (eg, dyspnoea, cough & fever). Discontinue use & treat patient appropriately if ILD is confirmed. Perform periodic LFT; consider discontinuation if changes are severe. Possible cerebrovascular events. Concomitant use w/ CYP3A4 inducers (eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort); drugs causing significant sustained elevation in gastric pH may reduce efficacy. Regularly monitor changes in prothrombin time or INR in patients taking warfarin. Advise patients to promptly seek medical advice in the event of developing severe or persistent diarrhoea, nausea, vomiting or anorexia. Promptly refer to an ophthalmologist if patient presents w/ signs & symptoms suggestive of keratitis (eg, acute or worsening eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain &/or red eye). Interrupt treatment if diagnosis of ulcerative keratitis is confirmed; consider permanent discontinuation if symptoms do not resolve or recur on reintroduction of treatment. Patients w/ history of keratitis, ulcerative keratitis or severe dry eye. Possible CNS haemorrhages. May exacerbate neutropenic effect of vinorelbine. Possible GI perforation associated w/ other known risk factors including increasing age, concomitant use of steroids or NSAIDs, underlying history of GI ulceration, smoking or bowel metastases at sites of perforation. Possible asthenia during treatment; observe caution when driving or using machines. Women of childbearing potential must be advised to avoid becoming pregnant. Pregnancy. Recommend to discontinue nursing while receiving therapy. Not recommended for use in childn or adolescents.
Adverse Reactions
Anorexia; diarrhoea, vomiting, nausea, stomatitis; elevated ALT; skin reactions (eg, pustular rash, itchy w/ dry skin including skin fissures on an erythematous base); asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage (eg, epistaxis & haematuria); ILD; dehydration, dry mouth; elevated AST & total bilirubin; nail disorder, alopecia, allergic reactions including angioedema & urticaria; asymptomatic lab elevations in blood creatinine, proteinuria, cystitis; pyrexia.
Drug Interactions
Reduced mean AUC w/ rifampicin & ranitidine. Increased mean AUC w/ itraconazole & other CYP3A4 inhbitors (eg, ketoconazole, clotrimazole, ritonavir). Risk of elevated INR &/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.
Presentation/Packing
Form
Iressa FC tab 250 mg
Packing/Price
30's
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in