"The U.S. Food and Drug Administration today granted accelerated approval to Zykadia (ceritinib) for patients with a certain type of late-stage (metastatic) non-small cell lung cancer (NSCLC).
Zykadia is an anaplastic lymphoma kinase (ALK)"...
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
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.
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 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:
- Confirmed interstitial lung disease (ILD) [see WARNINGS AND PRECAUTIONS]
- Severe hepatic impairment [see WARNINGS AND PRECAUTIONS]
- Gastrointestinal perforation [see WARNINGS AND PRECAUTIONS]
- Persistent ulcerative keratitis [see WARNINGS AND PRECAUTIONS]
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].
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 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 7/15/2015
Additional Iressa Information
Report Problems to the Food and Drug Administration
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