IRESSA TABLET 250 mg

4.1 Therapeutic indications

IRESSA is indicated for the treatment of patients with locally advanced or metastatic Non Small Cell Lung Cancer (NSCLC) who have activating mutations of the EGFR TK.

4.3 Contraindications

Known severe hypersensitivity to the active substance or to any of the excipients of this product.

4.2 Posology and method of administration

IRESSA treatment should only be initiated by a medical specialist experienced in the treatment of patients with advanced NSCLC.

The recommended dose of IRESSA is one 250 mg tablet once a day, taken with or without food. 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.

Where dosing of whole tablets is not possible, such as patients who are only able to swallow liquids, tablets may be administered as a dispersion in water. The tablet should be dropped into half a glass of drinking water (non-carbonated), without crushing, and the glass stirred until the tablet has dispersed (approximately 15 minutes) and the contents subsequently drunk immediately. The glass should be rinsed with a further half glass of water and the contents drunk. The liquid can also be administered via a nasogastric tube.

IRESSA is not recommended for use in children or adolescents as safety and effectiveness in these patient populations has not been studied.

No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity, mild to moderate renal impairment or in patients with moderate to severe hepatic impairment due to liver metastases (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Dosage adjustment: Patients with poorly tolerated diarrhoea or skin adverse drug 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

In the event of acute onset or worsening of pulmonary symptoms (dyspnoea, cough, fever), IRESSA therapy should be interrupted and a prompt investigation of these symptoms should occur and appropriate treatment initiated. If interstitial lung disease is confirmed, IRESSA should be discontinued and the patient treated appropriately.

Patients who develop onset of new eye symptoms such as pain should be medically evaluated and managed appropriately, including IRESSA therapy interruption and removal of an aberrant eyelash if present. After symptoms and eye changes have resolved, the decision should be made concerning reinstatement of the 250 mg daily dose.