August 3, 2015
Recommended Topic Related To:

Iressa

"Jan. 13, 2015 -- Drug-maker Bristol-Myers Squibb says a trial of nivolumab (Opdivo) has been stopped early because the drug improves how long people with a type of advanced lung cancer live compared to chemotherapy.

This is the first time a"...

Iressa




Indications
Dosage
How Supplied

INDICATIONS

IRESSA is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test [see Clinical Studies].

Limitation of Use

Safety and efficacy of IRESSA have not been established in patients with metastatic NSCLC whose tumors have EGFR mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Patient Selection

Select patients for the first-line treatment of metastatic NSCLC with IRESSA based on the presence of EGFR exon 19 deletion or exon 21 (L858R) substitution mutations in their tumor [see INDICATIONS AND USAGE, Clinical Studies]. Information on FDA-approved tests for the detection of EGFR mutations in NSCLC is available at: http://www.fda.gov/CompanionDiagnostics.

Recommended Dose

The recommended dose of IRESSA is 250 mg orally once daily with or without food until disease progression or unacceptable toxicity.

Do not take a missed dose within 12 hours of the next dose.

Administration To Patients Who Have Difficulty Swallowing Solids

Immerse IRESSA tablets in 4 to 8 ounces of water by dropping the tablet in water, and stir for approximately 15 minutes. Immediately drink the liquid or administer through a naso-gastric tube. Rinse the container with 4 to 8 ounces of water and immediately drink or administer through the naso-gastric tube.

Dose Modification

Dose Modifications for Adverse Drug Reactions

Withhold IRESSA (for up to 14 days) for any of the following:

  • Acute onset or worsening of pulmonary symptoms (dyspnea, cough, fever) [see WARNINGS AND PRECAUTIONS]
  • NCI CTCAE Grade 2 or higher in ALT and/or AST elevations [see WARNINGS AND PRECAUTIONS]
  • NCI CTCAE Grade 3 or higher diarrhea [see WARNINGS AND PRECAUTIONS]
  • Signs and symptoms of severe or worsening ocular disorders including keratitis [see WARNINGS AND PRECAUTIONS]
  • NCI CTCAE Grade 3 or higher skin reactions [see WARNINGS AND PRECAUTIONS]

Resume treatment with IRESSA when the adverse reaction fully resolves or improves to NCI CTCAE Grade 1.

Permanently discontinue IRESSA for:

Dose Modifications for Drug Interactions

Strong CYP3A4 Inducers

Increase IRESSA to 500 mg daily in the absence of severe adverse drug reaction, and resume IRESSA at 250 mg seven days after discontinuation of the strong CYP3A4 inducer [see DRUG INTERACTIONS, CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

250 mg tablets: round, biconvex, brown film-coated, debossed with “IRESSA 250” on one side and plain on the other side.

Storage And Handling

IRESSA® (gefitinib) is available as 250 mg tablets.

IRESSA 250 mg tablets are round, biconvex, brown film-coated, debossed with “IRESSA 250” on one side and plain on the other side.

IRESSA® (gefitinib) tablets are supplied as:

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

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

Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Manufacture by: AstraZeneca UK Limited Macclesfield, Cheshire, England. Product of Belgium. Revised: July 2015

Last reviewed on RxList: 7/15/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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