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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 int |
