Drug Action
Gefitinib is a tyrosine kinase inhibitor.
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Drug reference
Gefitinib is a tyrosine kinase inhibitor.
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Treatment of locally advanced or metastatic non-small cell lung cancer with activating mutations of epidermal growth factor receptor ▶BY MOUTH ▶Adult: 250 mg once daily
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NICE decisions ▶Gefitinib for the first-line treatment of locally advanced or metastatic non-small-cell lung cancer (July 2010) NICE TA192 Gefitinib (Iressa ®) is recommended as an option for the first-line treatment of locally advanced or metastatic non- small-cell lung cancer if the patient tests positive for the epidermal growth receptor tyrosine kinase (EGFR-TK) mutation and the manufacturer provides gefitinib at the fixed price agreed under the patient access scheme. www.nice.org.uk/guidance/ta192 ▶Erlotinib and gefitinib for treating non-small-cell lung cancer that has progressed after prior chemotherapy (December 2015) NICE TA374 Gefitinib (Iressa ®) is not recommended for treating locally advanced or metastatic non-small-cell lung cancer that has progressed after non-targeted chemotherapy in patients with tumours that are EGFR-TK mutation- positive. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta374 Scottish Medicines Consortium (SMC) decisions SMC No. 615/10 The Scottish Medicines Consortium has advised (December 2015) that gefitinib (Iressa ®) is accepted for restricted use within NHS Scotland for the treatment of adults with previously untreated locally advanced or metastatic non- small cell lung cancer with activating mutations of epidermal growth factor receptor tyrosine kinase. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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MHRA/CHM ADVICE: EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) INHIBITORS: SERIOUS CASES OF KERATITIS AND ULCERATIVE KERATITIS (MAY 2012) Keratitis and ulcerative keratitis have been reported following treatment with epidermal growth factor receptor (EGFR) inhibitors for cancer (cetuximab, erlotinib, gefitinib and panitumumab). In rare cases, this has resulted in corneal perforation and blindness. Patients undergoing treatment with EGFR inhibitors who present with acute or worsening signs and symptoms suggestive of keratitis should be referred promptly to an ophthalmology specialist. Treatment should be interrupted or discontinued if ulcerative keratitis is diagnosed. RISKS OF INCORRECT DOSING OF ORAL ANTI-CANCER MEDICINES See Cytotoxic drugs p. 938.
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→Appendix 1: gefitinib
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▶Common or very common Alopecia. angioedema. appetite decreased. asthenia. cystitis. dehydration. diarrhoea. dry eye. dry mouth. eye inflammation. fever. haemorrhage. hypersensitivity. interstitial lung disease (discontinue). nail disorder. nausea. proteinuria. rash pustular. skin reactions. stomatitis. vomiting ▶Uncommon Corneal erosion. gastrointestinal perforation. hepatic disorders. pancreatitis ▶Rare or very rare Cutaneous vasculitis. severe cutaneous adverse reactions (SCARs)
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Contraceptive advice required, see Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid unless essential—toxicity in animal studies. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Discontinue breast-feeding.
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Manufacturer advises caution in moderate to severe impairment due to cirrhosis—monitor for adverse events (risk of increased drug plasma concentrations).
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Manufacturer advises caution if creatinine clearance less than 20 mL/minute.
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▶Monitor for worsening of dyspnoea, cough and fever— discontinue if interstitial lung disease confirmed. ▶Monitor liver function—consider discontinuing if severe changes in liver function occur.
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There can be variation in the licensing of different medicines containing the same drug. Tablet ▶Gefitinib (Non-proprietary) Gefitinib 250 mg Gefitinib 250mg tablets | 30 tablet P £1,500.00–£2,167.71 | 30 tablet P £2,166.10 (Hospital only) ▶Iressa (AstraZeneca UK Ltd) Gefitinib 250 mg Iressa 250mg tablets | 30 tablet P £2,167.71
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250 mg once daily
First-line fragment. Read the complete Indications and Dose section above.
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