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Augtyro

repotrectinib
ROS1/TRK TKI FDA Approved 2023 BMS
Route
Oral
Half-Life
35 hrs
FDA Approved
2023
Manufacturer
BMS
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1. Indications and Usage

NSCLC: ROS1-positive locally advanced or metastatic NSCLC.

2. Dosage and Administration

160 mg once daily ×14 days, then 160 mg twice daily.

3. Dosage Forms and Strengths

Capsules: 40 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • CNS Reactions: Dizziness (58%), cognitive/mood disorders.
  • ILD/Pneumonitis: Permanently discontinue if confirmed.
  • Hepatotoxicity: Monitor LFTs.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Dizziness (58%), Dysgeusia (50%), Fatigue (35%), Constipation (35%), Nausea (24%), Ataxia (20%), Dyspnea (18%), Cognitive Disorders (13%)

Dizziness
58%
Dysgeusia
50%
Fatigue
35%
Constipation
35%
Nausea
24%
Ataxia
20%
Dyspnea
18%
Cognitive Disorders
13%

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

7. Drug Interactions

Strong CYP3A Inhibitors/Inducers: Avoid.

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

Next-generation ROS1/TRK inhibitor overcoming resistance mutations including ROS1 G2032R.

Pharmacokinetics

Tmax: 2-4h. Protein binding: 96%. t½: 34h.

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

Augtyro 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 Augtyro. 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 Augtyro (repotrectinib) approved for?

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

How is Augtyro (repotrectinib) administered?

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

How does Augtyro (repotrectinib) work?

Next-generation ROS1/TRK inhibitor overcoming resistance mutations including ROS1 G2032R.

What are the most common side effects?

Dizziness (58%), Dysgeusia (50%), Fatigue (35%), Constipation (35%), Nausea (24%), Ataxia (20%), Dyspnea (18%), Cognitive Disorders (13%) Dizziness 58% Dysgeusia 50% Fatigue 35% Constipation 35% Nausea 24% Ataxia 20% Dyspnea 18% Cognitive Disorders 13%

← All Therapies Full Prescribing Information ↗