See related Iressa film-coated tab information |
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Manufacturer |
AstraZeneca |
Distributor |
Hong Kong: Zuellig/Macau: Four Star |
Contents |
Gefitinib |
Indications |
1st-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of epidermal growth factor receptor tyrosine kinase (EGFR TK). Treatment of locally advanced or metastatic NSCLC after failure of cytotoxic chemotherapy. Previous therapy should have included a platinum & a taxane.
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Dosage |
250 mg once daily.
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Overdosage |
View Iressa overdosage for action to be taken in the event of an overdose. |
Administration |
May be taken with or without food (Disperse tab in ½ glass of drinking water (non-carbonated) w/o crushing it; stir until dispersed then drink immediately. The liqd may also be administered via a nasogastric tube.). |
Contraindications |
Severe hypersensitivity. Pregnancy & lactation.
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Special Precautions |
EGFR mutation assessment is recommended for 1st-line treatment. Interstitial lung disease. Worsening of resp symptoms. Asymptomatic increases in liver transaminases.
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Adverse Drug Reactions |
Diarrhoea, nausea, vomiting, stomatitis, elevations in ALT, anorexia, rash, asthenia.
View ADR Monitoring Form |
Drug Interactions |
CYP3A4 inhibitors eg itraconazole, ketoconazole, clotrimazole & ritonavir. CYP3A4 inducers eg rifampicin, phenytoin, carbamazepine, barbiturates & St. John's wort. Drugs that increase gastric pH. Warfarin; metoprolol.
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Pregnancy Category (US FDA) |
Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective). |
Storage |
View Iressa storage conditions for details to ensure optimal shelf-life. |
Mechanism of Action |
View Iressa mechanism of action for pharmacodynamics and pharmacokinetics details. |
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