VEIASU FILM-COATED TABLETS 250 MG [SIN16030P]

Product Info

VEIASU FILM-COATED TABLETS 250 MG

[SIN16030P]

4.1 Therapeutic indications
Gefitinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR-TK (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration
Treatment with gefitinib should be initiated and supervised by a physician experienced in the use of anticancer therapies.

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

The recommended posology of gefitinib is one 250 mg tablet once a day. If a dose 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.

Gefitinib 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 5.1 – 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) gefitinib therapy should be interrupted and a prompt investigation of these symptoms should occur and appropriate treatment initiated. If interstitial lung disease is confirmed, gefitinib 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 Gefitinib 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.

Method of administration
The tablet may be taken orally with or without food, at about the same time each day.
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.

4.3 Contraindications

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• Breast-feeding (see section 4.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).