Iressa Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Gefitinib

Indications/Uses

Adults w/ locally advanced or metastatic NSCLC w/ activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR-TK).

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Dosage/Direction for Use

250 mg once daily.

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Overdosage

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Administration

May be taken with or without food: May also be dispersed in ½ glass of non-carbonated water. Drop in water & stir w/o crushing until it disperses (approx 15 min). Drink immediately. Rinse glass w/ another ½ glass of water & drink. Dispersed liqd may also be administered via nasogastric tube.

Contraindications

Hypersensitivity.

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Special Precautions

Discontinue use if ILD, ulcerative keratitis is confirmed. Cerebrovascular events; severe or persistent diarrhoea, nausea, vomiting or anorexia; keratitis; GI perforation or ulceration, bowel metastases at perforation site; smoking. Assess EGFR mutation of tumour tissue prior to treatment. Periodically monitor LFTs. Regularly monitor prothrombin time or INR changes in patients taking warfarin. Concomitant use w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort; drugs causing significant sustained gastric pH elevations; vinorelbine; steroids or NSAIDs. May affect ability to drive & use machines. Mild to moderate hepatic function changes. Women of childbearing potential should use effective contraception. Avoid use during pregnancy. Not to be used during lactation. Not recommended in childn or adolescents.

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Use In Pregnancy & Lactation

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Adverse Reactions

Anorexia; diarrhoea, vomiting, nausea, stomatitis; elevated ALT; pustular rash including skin fissures; asthenia. Conjunctivitis, blepharitis, dry eye; haemorrhage eg, epistaxis, haematuria; ILD; dehydration, dry mouth; elevated AST & total bilirubin; nail disorder, alopecia, allergic reactions eg, angioedema, urticaria; asymptomatic lab elevations in blood creatinine, proteinuria, cystitis; pyrexia.

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Drug Interactions

Reduced mean AUC w/ rifampicin, ranitidine. Increased mean AUC w/ itraconazole. Elevated INR &/or bleeding events w/ warfarin. Reduced efficacy w/ CYP3A4 inducers eg, phenytoin, carbamazepine, rifampicin, barbiturates or St. John's wort. Exacerbated neutropenic effect of vinorelbine.

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Storage

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Description

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Action

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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.

Regulatory Classification

Presentation/Packing

Form

Iressa FC tab 250 mg

Packing/Price

30's

Iressa

gefitinib

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma