View by Tumor Type
Breast Cancer
Home › All Therapies › Tykerb

Tykerb

lapatinib
Dual HER2/EGFR TKI FDA Approved 2007 Novartis
Route
Oral
Half-Life
24 hrs
FDA Approved
2007
Manufacturer
Novartis
Navigation -->
1. Indications and Usage

HER2+ mBC with capecitabine or letrozole.

2. Dosage and Administration

1250 mg or 1500 mg daily empty stomach.

3. Dosage Forms and Strengths

Tablets: 250 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Hepatotoxicity: Fatal. Monitor LFTs.
  • LVEF Decrease: Assess.
  • QTc: Monitor ECGs.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Diarrhea (65%), PPE (53%), Nausea (44%), Rash (28%), Fatigue (20%), Vomiting (18%)

Diarrhea
65%
PPE
53%
Nausea
44%
Rash
28%
Fatigue
20%
Vomiting
18%

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

7. Drug Interactions

Avoid CYP3A4 modulators.

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 dual EGFR/HER2 TKI.

Pharmacokinetics

t1/2: ~24h.

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

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

Breast 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 Tykerb. 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 Tykerb (lapatinib) approved for?

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

How is Tykerb (lapatinib) administered?

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

How does Tykerb (lapatinib) work?

Reversible dual EGFR/HER2 TKI.

What are the most common side effects?

Diarrhea (65%), PPE (53%), Nausea (44%), Rash (28%), Fatigue (20%), Vomiting (18%) Diarrhea 65% PPE 53% Nausea 44% Rash 28% Fatigue 20% Vomiting 18%

← All Therapies Full Prescribing Information ↗