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Iressa

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Iressa

Indications
Dosage
How Supplied

INDICATIONS

IRESSA (getfitinib) is indicated as monotherapy for the continued treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies who are benefiting or have benefited from IRESSA (getfitinib) .

In light of positive survival data with other agents including another oral EGFR inhibitor, physicians should use other treatment options in advanced non-small cell lung cancer patient populations who have received one or two prior chemotherapy regimens and are refractory or intolerant to their most recent regimen.

The effectiveness of IRESSA (getfitinib) was initially based on objective response rates (see CLINICAL PHARMACOLOGY - Clinical Studies section). Subsequent studies intended to demonstrate an increase in survival have been unsuccessful. Specifically, results from a large placebo-controlled randomized trial in patients with advanced NSCLC who progressed while receiving or within 90 days of the last dose of chemotherapy or were intolerant to the most recent prior chemotherapy regimen, did not show an improvement in survival (see CLINICAL PHARMACOLOGY - Clinical Studies section).

Results from two large, controlled, randomized trials in first-line treatment of non-small cell lung cancer showed no benefit from adding IRESSA (getfitinib) to doublet, platinum-based chemotherapy.

DOSAGE AND ADMINISTRATION

The recommended daily dose of IRESSA (getfitinib) 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 (getfitinib) tablets can also be dispersed in half a glass of drinking water (noncarbonated). 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.

Dosage Adjustment

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 (getfitinib) therapy should be interrupted and a prompt investigation of these symptoms should occur and appropriate treatment initiated. If interstitial lung disease is confirmed, IRESSA (getfitinib) 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 (getfitinib) 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).

HOW SUPPLIED

IRESSA (getfitinib) tablets are supplied as round, biconvex, brown film-coated tablets intagliated with “IRESSA (getfitinib) 250” on one side and plain on the other side, each containing 250 mg of gefitinib.

Bottles of 30 Tablets (NDC 0310-0482-30)

Storage

Store at controlled room temperature 20-25°C (68-77°F) [see USP].

Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. By: AstraZeneca UK Limited, Macclesfield, Cheshire, England. Made in the United Kingdom. Rev 06/05. FDA revision date: 6/17/2005

Last reviewed on RxList: 10/2/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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