Rozlytrek (Entrectinib) 200mg Capsules | Hong Kong-Sourced NTRK/ROS1 Inhibitor | GLT
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Generic Name: Entrectinib
Brand Name: Rozlytrek (Roche)
Drug Class: Multikinase inhibitor — NTRK1/2/3 (TRKA/B/C) and ROS1 inhibitor
Manufacturer: Roche (Hong Kong) Limited
Strength: 200mg capsules × 90's
Initial U.S. FDA Approval: 2019
What is Rozlytrek (Entrectinib) Used For?
Rozlytrek (entrectinib) is an oral kinase inhibitor that selectively targets the neurotrophic tyrosine receptor kinases NTRK1, NTRK2, and NTRK3 (TRKA, TRKB, TRKC) as well as ROS1. It is FDA-approved for two indications: (1) adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC); and (2) adult and pediatric patients (12 years and older) with NTRK gene fusion-positive solid tumors that are metastatic or where surgery would likely cause severe morbidity, and who have progressed or have no satisfactory alternative therapy. The NTRK solid-tumor indication was approved under accelerated approval based on tumor response rate and durability of response.
How Does Rozlytrek Work?
Entrectinib inhibits the kinase activity of TRKA, TRKB, and TRKC (encoded by the NTRK1, NTRK2, and NTRK3 genes) and ROS1. NTRK gene fusions and ROS1 rearrangements act as oncogenic drivers in a variety of solid tumors. By blocking these targets, entrectinib suppresses the growth of fusion-driven tumors across tumor types (tumor-agnostic).
Approved Indications
- Adult patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC)
- Adult and pediatric patients (12 years and older) with NTRK fusion-positive solid tumors (tumor-agnostic indication)
Dosage & Administration
The recommended adult dosage is 600 mg taken orally once daily, with or without food. Rozlytrek is available as 100 mg and 200 mg capsules. Pediatric dosing (12 years and older) is based on body surface area. Do not crush, chew, or open the capsules. Treatment selection should be based on the presence of a ROS1 rearrangement or NTRK gene fusion as detected by an approved test.
Warnings & Precautions
- Congestive heart failure — assess left ventricular ejection fraction before initiation and monitor for signs and symptoms of CHF
- Central nervous system effects — cognitive impairment, mood disorders, dizziness, and sleep disturbances may occur
- Skeletal fractures — entrectinib increases fracture risk
- Hepatotoxicity — monitor liver tests (ALT/AST) every 2 weeks during the first month, then monthly
- Hyperuricemia and QT interval prolongation — assess at baseline and monitor during treatment
- Vision disorders — withhold for new or worsening visual changes
Common Side Effects
Common adverse reactions include fatigue, constipation, dysgeusia (altered taste), dizziness, diarrhea, nausea, and peripheral edema. Report any persistent or severe symptoms to your physician.
Storage
Store at room temperature (20°C to 25°C) in the original container, protected from moisture. Keep out of reach of children.
Why Choose GLT?
- Hong Kong-licensed pharmaceutical wholesaler with verifiable business registration
- Full product documentation: COA, MSDS, and regulatory dossiers
- Cold-chain (2-8°C) for biologics & injectables; ambient shipping for tablets & capsules
- Serving both institutions (hospitals, pharmacies, distributors) and individual patients
- Global shipping with customs documentation and secure delivery
How to Order
Contact GLT via WhatsApp (+86 15234153837) or email ([email protected]) for pricing, availability, and full product documentation including COA, MSDS, and regulatory dossiers. Responses within 24 hours.
Frequently Asked Questions
Q: Is Rozlytrek the same as generic entrectinib?
A: Rozlytrek is the original Roche-brand formulation of entrectinib. Generic and licensed versions (e.g., from other markets) contain the same active ingredient but may differ in manufacturer and packaging. This listing is for the Roche (Hong Kong) original-brand product.
Q: What strength is available?
A: This listing is for 200 mg capsules × 90's (one capsule taken once daily).