Generic name: gefitinib
Dosage form: tablet, coated
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The recommended daily dose of IRESSA is one 250 mg tablet with or without food. Higher doses do not give a better response and cause increased toxicity.
For Patients who have Difficulty Swallowing Solids
IRESSA tablets can also be dispersed in half a glass of drinking water (non-carbonated). No other liquids should be used. Drop the tablet in the water, without crushing it, stir until the tablet is dispersed (approximately 10 minutes) and drink the liquid immediately. Rinse the glass with half a glass of water and drink. The liquid can also be administered through a naso-gastric tube.
Patients with poorly tolerated diarrhea (sometimes associated with dehydration) 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 daily dose.
In the event of acute onset or worsening of pulmonary symptoms (dyspnea, 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 (see WARNINGS-Pulmonary Toxicity, PRECAUTIONS-Information for Patients and ADVERSE REACTIONS sections).
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 (see PRECAUTIONS-Information for Patients and ADVERSE REACTIONS sections).
In patients receiving a potent CYP3A4 inducer such as rifampicin or phenytoin, a dose increase to 500 mg daily should be considered in the absence of severe adverse drug reaction, and clinical response and adverse events should be carefully monitored (see CLINICAL PHARMACOLOGY-Pharmacokinetics-Drug-Drug Interactions and PRECAUTIONS-Drug Interactions sections).
No dosage adjustment is required on the basis of patient age, body weight, gender, ethnicity, or renal function; or in patients with moderate to severe hepatic impairment due to liver metastases (see CLINICAL PHARMACOLOGY-Pharmacokinetics-Special Populations section).