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Tarceva

erlotinib
EGFR TKI FDA Approved 2004 Genentech / Roche
Route
Oral
Half-Life
36 hrs
FDA Approved
2004
Manufacturer
Genentech / Roche
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1. Indications and Usage

NSCLC: EGFR-mutant NSCLC (first-line, maintenance, and after prior chemo).
Pancreatic: With gemcitabine for advanced disease.

2. Dosage and Administration

NSCLC: 150 mg daily on empty stomach. Pancreatic: 100 mg daily.

3. Dosage Forms and Strengths

Tablets: 25 mg, 100 mg, 150 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • ILD: Fatal cases. Discontinue.
  • Hepatotoxicity: Monitor LFTs.
  • GI Perforation: Fatal cases.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Rash (75%), Diarrhea (54%), Decreased Appetite (52%), Fatigue (52%), Nausea (33%), Infection (24%), Vomiting (23%), Stomatitis (17%)

Rash
75%
Diarrhea
54%
Decreased Appetite
52%
Fatigue
52%
Nausea
33%
Infection
24%
Vomiting
23%
Stomatitis
17%

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

7. Drug Interactions

CYP3A4 Inhibitors: Consider dose reduction.
Smoking: Increases clearance.
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 blocking proliferative/survival signaling in EGFR-mutant cells.

Pharmacokinetics

Tmax: 4h. Bioavailability: ~60%. t½: ~36h. Feces 83%.

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 Tarceva Trials on ClinicalTrials.gov ↗ 📚 PubMed: Tarceva Clinical Trials ↗
FDA-Approved Tumor Types

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

Non-Small Cell Lung Cancer Pancreatic 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 Tarceva. 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 Tarceva (erlotinib) approved for?

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

How is Tarceva (erlotinib) administered?

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

How does Tarceva (erlotinib) work?

Reversible EGFR TKI blocking proliferative/survival signaling in EGFR-mutant cells.

What are the most common side effects?

Rash (75%), Diarrhea (54%), Decreased Appetite (52%), Fatigue (52%), Nausea (33%), Infection (24%), Vomiting (23%), Stomatitis (17%) Rash 75% Diarrhea 54% Decreased Appetite 52% Fatigue 52% Nausea 33% Infection 24% Vomiting 23% Stomatitis 17%

← All Therapies Full Prescribing Information ↗