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Gilotrif

afatinib
Pan-HER TKI FDA Approved 2013 Boehringer Ingelheim
Route
Oral
Half-Life
37 hrs
FDA Approved
2013
Manufacturer
Boehringer Ingelheim
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1. Indications and Usage

NSCLC: First-line for EGFR-mutant NSCLC. Also squamous NSCLC after platinum chemotherapy.

2. Dosage and Administration

40 mg orally once daily on empty stomach.

3. Dosage Forms and Strengths

Tablets: 20 mg, 30 mg, 40 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Diarrhea: Can be severe/fatal.
  • Bullous Skin Disorders: Fatal reactions reported.
  • ILD: Discontinue if confirmed.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (96%), Rash (90%), Stomatitis (71%), Paronychia (58%), Dry Skin (31%), Decreased Appetite (29%), Nausea (25%), Pruritus (21%)

Diarrhea
96%
Rash
90%
Stomatitis
71%
Paronychia
58%
Dry Skin
31%
Decreased Appetite
29%
Nausea
25%
Pruritus
21%

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

7. Drug Interactions

P-gp Inhibitors: Reduce by 10 mg.
P-gp Inducers: Increase by 10 mg.

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

Irreversible ErbB family blocker covalently binding EGFR, HER2, HER4, blocking HER3 transphosphorylation.

Pharmacokinetics

Tmax: 2-5h. Protein binding: ~95%. t½: 37h. Feces 85%.

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

Gilotrif 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 Gilotrif. 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 Gilotrif (afatinib) approved for?

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

How is Gilotrif (afatinib) administered?

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

How does Gilotrif (afatinib) work?

Irreversible ErbB family blocker covalently binding EGFR, HER2, HER4, blocking HER3 transphosphorylation.

What are the most common side effects?

Diarrhea (96%), Rash (90%), Stomatitis (71%), Paronychia (58%), Dry Skin (31%), Decreased Appetite (29%), Nausea (25%), Pruritus (21%) Diarrhea 96% Rash 90% Stomatitis 71% Paronychia 58% Dry Skin 31% Decreased Appetite 29% Nausea 25% Pruritus 21%

← All Therapies Full Prescribing Information ↗