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Tepmetko

tepotinib
MET Inhibitor FDA Approved 2021 EMD Serono
Route
Oral
Half-Life
32 hrs
FDA Approved
2021
Manufacturer
EMD Serono
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1. Indications and Usage

MET exon 14 skipping NSCLC.

2. Dosage and Administration

450 mg daily with food.

3. Dosage Forms and Strengths

Tablets: 225 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • ILD: Discontinue.
  • Hepatotoxicity: Monitor.
  • Embryo-Fetal Toxicity: Fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Edema (63%), Albumin Decrease (30%), Nausea (27%), Fatigue (27%), Creatinine (25%), Diarrhea (22%)

Edema
63%
Albumin Decrease
30%
Nausea
27%
Fatigue
27%
Creatinine
25%
Diarrhea
22%

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

7. Drug Interactions

May increase P-gp substrates.

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

Selective oral MET inhibitor.

Pharmacokinetics

t1/2: 32h.

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

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

NSCLC
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 Tepmetko. 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 Tepmetko (tepotinib) approved for?

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

How is Tepmetko (tepotinib) administered?

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

How does Tepmetko (tepotinib) work?

Selective oral MET inhibitor.

What are the most common side effects?

Edema (63%), Albumin Decrease (30%), Nausea (27%), Fatigue (27%), Creatinine (25%), Diarrhea (22%) Edema 63% Albumin Decrease 30% Nausea 27% Fatigue 27% Creatinine 25% Diarrhea 22%

← All Therapies Full Prescribing Information ↗