- Hypersensitivity to the active substance or to any of the excipients of the drug.
- Breast-feeding
When considering the use of gefitinib as a treatment for locally advanced or metastatic NSCLC, it is important that EGFR mutation assessment of the tumour tissue is attempted for all patients. If a tumour sample is not evaluable, then circulating tumour DNA (ctDNA) obtained from a blood (plasma) sample may be used.
Interstitial lung disease (ILD)
Interstitial lung disease (ILD), which may be acute in onset, has been observed in 1.3 % of patients receiving gefitinib, and some cases have been fatal. If patients experience worsening of respiratory symptoms such as dyspnoea, cough and fever, gefitinib should be interrupted and the patient should be promptly investigated. If ILD is confirmed, gefitinib should be discontinued and the patient treated appropriately.
Hepatotoxicity and liver impairment
Gefitinib should be used cautiously in the presence of mild to moderate changes in liver function. Discontinuation should be considered if changes are severe if changes in the liver enzymes alanine.
Impaired liver function due to cirrhosis has been shown to lead to increased plasma concentrations of gefitinib
Further precautions for use
Patients should be advised to seek medical advice immediately if they experience severe or persistent diarrhoea, nausea, vomiting or anorexia as these may indirectly lead to dehydration. These symptoms should be managed as clinically indicated.
Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
If a diagnosis of ulcerative keratitis is confirmed, treatment with gefitinib should be interrupted, and if symptoms do not resolve, or if symptoms recur on reintroduction of gefitinib, permanent discontinuation should be considered.
Gastrointestinal perforation has been reported in patients taking gefitinib. In most cases this is associated with other known risk factors, including concomitant medications such as steroids or NSAIDs, underlying histo
