Description
Indication & Scope
Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring ROS1 or NTRK gene fusions.
- Mechanism: Potent selective next-generation TRK and ROS1 tyrosine kinase inhibitor (TKI). It binds to ATP-binding pocket of ROS1/TRK fusion proteins, inhibits downstream oncogenic signaling, blocks tumor cell proliferation and induces apoptosis. Effective against most acquired resistance mutations of first-generation TRK/ROS1 inhibitors.
- Drug class: Tyrosine Kinase Inhibitor (TKI), oral targeted anti-lung cancer therapeutic agent
- Clinical use: First-line and second-line targeted therapy for ROS1-positive or NTRK-fusion positive locally advanced/metastatic NSCLC.
| Generic Name | Repotrectinib Capsules |
| Brand Name | AUGTYRO |
| Ingredient | Repotrectinib Capsules |
| Dosage Form | Capsules |
| Package | 40mg*120 capsules/box |
| Conditions Treated | Locally advanced or metastatic non-small cell lung cancer |
| Taboos | 1. Hypersensitivity to repotrectinib or capsule excipients
2. Uncontrolled severe QT interval prolongation 3. Severe untreated hepatic impairment 4. Pregnant women |
| Place of origin | 2100 Syntex Court, Mississauga, Ontario L5N 7K9 CANADA |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed and light-proof storage at 20°C~25°C, permitted range 15°C~30°C, avoid moisture. |
| Manufacturer | Bristol-Myers Squibb Company, Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | HJ20240018 |
| Date of Revision | 2024 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: 160 mg orally twice daily for adult patients. Dose adjustment is allowed based on adverse reaction severity.
Time: Taken at 12-hour intervals, with or without food.
Instructions for use:
1. Confirm ROS1/NTRK fusion positive via companion diagnostic testing before initiation.
2. Swallow capsules whole; do not open or chew the contents.
3. Regular ECG monitoring for QT prolongation, liver function testing during treatment.
4. Missed doses should be skipped if less than 6 hours remain until next dose.
Interaction:
1. Strong CYP3A4 inhibitors significantly raise repotrectinib exposure and toxicity risk.
2. Strong CYP3A4 inducers reduce drug efficacy.
3. QT-prolonging medications increase arrhythmia risk when co-administered.
Side effects:
1. Common: Dizziness, dysgeusia, fatigue, constipation, elevated liver transaminases, myalgia
2. Severe: Severe hepatotoxicity, central nervous system adverse events, severe QT prolongation, interstitial lung disease
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What kinases does Repotrectinib inhibit, and what is its primary indication?
It is a potent inhibitor of ROS1 and TRK kinases, indicated for locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
What is the route of administration and typical dosing schedule for Repotrectinib?
It is taken orally once or twice daily, depending on the indication and tolerability.
Why is Repotrectinib considered a next-generation targeted therapy for ROS1-positive NSCLC?
Its ability to potently inhibit both wild-type and resistant ROS1 fusions provides a treatment option for patients who progress on first-generation ROS1 inhibitors.
How does Repotrectinib address resistance mutations that limit the efficacy of other ROS1 inhibitors?
It is designed to overcome ROS1 resistance mutations, including the G2032R solvent-front mutation, which commonly arises after treatment with earlier ROS1 inhibitors.
AUGTYRO® | Repotrectinib | Locally Advanced or Metastatic Non-small Cell Lung Cancer | DengYueRX
INN: Repotrectinib
Indications: Treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring ROS1 or NTRK gene fusions.
Dosage Form: Capsules
Strength: 40mg/capsule
