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Treatment with IRESSA should be initiated and supervised by a physician experienced in the use of anticancer therapies.
Posology
The recommended posology of IRESSA is one 250 mg tablet once a day. If a dose of IRESSA is missed, it should be taken as soon as the patient remembers. If it is less than 12 hours to the next dose, the patient should not take the missed dose. Patients should not take a double dose (two doses at the same time) to make up for a forgotten dose.
Paediatric population
The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established. There is no relevant use of IRESSA in the paediatric population in the indication of NSCLC.
Hepatic impairment
Patients with moderate to severe hepatic impairment (Child Pugh B or C) due to cirrhosis have increased plasma concentrations of gefitinib. These patients should be closely monitored for adverse events. Plasma concentrations were not increased in patients with elevated aspartate transaminase (AST), alkaline phosphatase or bilirubin due to liver metastases (see section 5.2 Pharmacokinetic properties).
Renal impairment
No dose adjustment is required in patients with impaired renal function at creatinine clearance >20 ml/min. Only limited data are available in patients with creatinine clearance  20 ml/min and caution is advised in these patients (see section 5.2 Pharmacokinetic properties).
Elderly
No dose adjustment is required on the basis of patient age (see section 5.2 Pharmacokinetic properties).
CYP2D6 poor metabolisers
No specific dose adjustment is recommended in patients with known CYP2D6 poor metaboliser genotype, but these patients should be closely monitored for adverse events (see section 5.2 Pharmacokinetic properties).
Dose adjustment due to toxicity
Patients with poorly tolerated diarrhoea or skin adverse reactions may be successfully managed by providing a brief (up to 14 days) therapy interruption followed by reinstatement of the 250 mg dose (see section 4.8 Undesirable effects). For patients unable to tolerate treatment after a therapy interruption, IRESSA should be discontinued and an alternative treatment should be considered.
Method of administration
The tablet may be taken with or without food, at about the same time each day. The tablet can be swallowed whole with some water or if dosing of whole tablets is not possible, tablets may be administered as a dispersion in water (non-carbonated). No other liquids should be used. Without crushing it, the tablet should be dropped in half a glass of drinking water. The glass should be swirled occasionally, until the tablet is dispersed (this may take up to 20 minutes). The dispersion should be drunk immediately after dispersion is complete (i.e. within 60 minutes). The glass should be rinsed |
