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APO-GEFITINIB (gefitinib tablets) should be administered under the supervision of a qualified health professional who is experienced in the treatment and management of patients with cancer.
APO-GEFITINIB should not be used in patients with EGFR mutation negative tumours (see Monitoring and Laboratory Tests under Precautions; Pharmacology: Clinical Trials under Actions).
APO-GEFITINIB has not been studied in patients with severe renal impairment (see Pharmacology: Pharmacokinetics: Special Populations and Conditions under Actions).
Isolated cases of hepatic failure and fulminant hepatitis, including fatalities, have been reported with gefitinib tablets use (see Hepatic/Biliary/Pancreatic: Hepatotoxicity under Precautions).
Gastrointestinal perforation (including cases with a fatal outcome) was observed in patients treated with gefitinib tablets (see Gastrointestinal under Precautions).
