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Tabrecta

capmatinib
MET Inhibitor FDA Approved 2020 Novartis
Route
Oral
Half-Life
6.5 hrs
FDA Approved
2020
Manufacturer
Novartis
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1. Indications and Usage

MET exon 14 skipping NSCLC.

2. Dosage and Administration

400 mg BID.

3. Dosage Forms and Strengths

Tablets: 150, 200 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 (51%), Nausea (44%), Creatinine (37%), Fatigue (32%), Vomiting (28%), Dyspnea (24%)

Edema
51%
Nausea
44%
Creatinine
37%
Fatigue
32%
Vomiting
28%
Dyspnea
24%

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

7. Drug Interactions

Avoid strong CYP3A inhibitors.

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 MET kinase inhibitor.

Pharmacokinetics

t1/2: 6.5h.

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

Tabrecta 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 Tabrecta. 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 Tabrecta (capmatinib) approved for?

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

How is Tabrecta (capmatinib) administered?

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

How does Tabrecta (capmatinib) work?

Selective MET kinase inhibitor.

What are the most common side effects?

Edema (51%), Nausea (44%), Creatinine (37%), Fatigue (32%), Vomiting (28%), Dyspnea (24%) Edema 51% Nausea 44% Creatinine 37% Fatigue 32% Vomiting 28% Dyspnea 24%

← All Therapies Full Prescribing Information ↗