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Home › All Therapies › Vitrakvi

Vitrakvi

larotrectinib
TRK Inhibitor FDA Approved 2018 Bayer
Route
Oral
Half-Life
2.9 hrs
FDA Approved
2018
Manufacturer
Bayer
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1. Indications and Usage

Solid tumors: NTRK fusion-positive solid tumors (tumor-agnostic).

2. Dosage and Administration

Adults: 100 mg BID. Pediatric BSA <1.0 m²: 100 mg/m² BID.

3. Dosage Forms and Strengths

Capsules: 25 mg, 100 mg. Oral solution: 20 mg/mL

4. Contraindications

None listed.

5. Warnings and Precautions
  • Neurotoxicity: Dizziness, gait disturbance.
  • Hepatotoxicity: Monitor LFTs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

AST Elevation (45%), Fatigue (37%), Nausea (29%), Dizziness (28%), Constipation (27%), Vomiting (26%), Cough (26%), Diarrhea (22%)

AST Elevation
45%
Fatigue
37%
Nausea
29%
Dizziness
28%
Constipation
27%
Vomiting
26%
Cough
26%
Diarrhea
22%

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

7. Drug Interactions

Strong CYP3A4 Inhibitors: Reduce dose 50%.

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 TRK A/B/C inhibitor blocking oncogenic NTRK fusion protein kinase activity.

Pharmacokinetics

Tmax: 1h. Bioavailability: 34%. t½: 2.9h. Feces 58%.

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

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

Tumor-agnostic indication — applies across multiple solid tumor types with qualifying biomarker.

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 Vitrakvi. 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 Vitrakvi (larotrectinib) approved for?

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

How is Vitrakvi (larotrectinib) administered?

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

How does Vitrakvi (larotrectinib) work?

Selective TRK A/B/C inhibitor blocking oncogenic NTRK fusion protein kinase activity.

What are the most common side effects?

AST Elevation (45%), Fatigue (37%), Nausea (29%), Dizziness (28%), Constipation (27%), Vomiting (26%), Cough (26%), Diarrhea (22%) AST Elevation 45% Fatigue 37% Nausea 29% Dizziness 28% Constipation 27% Vomiting 26% Cough 26% Diarrhea 22%

← All Therapies Full Prescribing Information ↗