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Iressa

gefitinib
EGFR TKI FDA Approved 2015 AstraZeneca
Route
Oral
Half-Life
48 hrs
FDA Approved
2015
Manufacturer
AstraZeneca
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1. Indications and Usage

NSCLC: First-line for EGFR exon 19 del or L858R NSCLC.

2. Dosage and Administration

250 mg orally once daily.

3. Dosage Forms and Strengths

Tablets: 250 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • ILD: 1.3% incidence including fatal cases.
  • Hepatotoxicity: Monitor LFTs monthly for 3 months.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Skin Reactions (47%), Diarrhea (29%), AST/ALT Elevation (8%), Stomatitis (7%), Decreased Appetite (6%), Nausea (5%)

Skin Reactions
47%
Diarrhea
29%
AST/ALT Elevation
8%
Stomatitis
7%
Decreased Appetite
6%
Nausea
5%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inducers: Increase to 500 mg.
PPIs: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Reversible EGFR TKI inhibiting intracellular EGFR phosphorylation in cells with activating mutations.

Pharmacokinetics

Tmax: 3-7h. Bioavailability: 60%. t½: 48h. Feces 86%.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Iressa Trials on ClinicalTrials.gov ↗ 📚 PubMed: Iressa Clinical Trials ↗
FDA-Approved Tumor Types

Iressa has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Non-Small Cell Lung Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Iressa. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Iressa (gefitinib) approved for?

Iressa (gefitinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Iressa (gefitinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Iressa (gefitinib) work?

Reversible EGFR TKI inhibiting intracellular EGFR phosphorylation in cells with activating mutations.

What are the most common side effects?

Skin Reactions (47%), Diarrhea (29%), AST/ALT Elevation (8%), Stomatitis (7%), Decreased Appetite (6%), Nausea (5%) Skin Reactions 47% Diarrhea 29% AST/ALT Elevation 8% Stomatitis 7% Decreased Appetite 6% Nausea 5%

← All Therapies Full Prescribing Information ↗