haiyitan glumetinib tablets 50mg per tablet

Description

Indication & Scope

Glumetinib is an oral anti-tumor agent for adult patients with locally advanced or metastatic non-small cell lung cancer harboring MET exon 14 skipping mutations, indicated for targeted monotherapy until disease progression or intolerable adverse reactions.

Mechanism
As a potent, highly selective small-molecule MET tyrosine kinase inhibitor, it competitively binds to MET kinase domain to block HGF/MET signaling cascade, suppress phosphorylation of downstream AKT and ERK, thereby inhibiting proliferation, migration and invasion of MET-mutated tumor cells.
Drug class
Class 1 innovative chemical drug, oral MET targeted tyrosine kinase inhibitor, anti-lung cancer therapeutic.
Clinical use
Global phase II GLORY clinical trials confirmed its prominent anti-tumor efficacy and favorable safety profile; clinically administered orally on an empty stomach at a fixed daily dose of 300mg, swallow whole film-coated tablets without chewing or crushing, the first domestic original MET inhibitor approved for MET exon 14 skipping NSCLC.

Specification

Generic Name	Glumetinib Tablets
Brand Name	HaiYiTan®
Ingredient	Glumetinib
Dosage Form	Film-coated tablets
Package	50mg*24 tablets/box
Conditions Treated	Treatment of adult patients with locally advanced or metastatic non-small cell lung cancer harboring MET exon 14 skipping mutations
Taboos	Contraindicated for patients with hypersensitivity to the active ingredient or any excipients of this product, or those with severe allergic history
Place of origin	Shanghai, China
Priscription Type	Prescription drug (Rx)
Storage Conditions	Seal tightly, store below 30℃, protected from light and moisture
Manufacturer	Haihe Biopharma Co., Ltd.
Registration Authority	National Medical Products Administration (NMPA)
Approval number	H20230010
Date of Revision	March 20, 2023
Shelf Life	24 months

How to use ?

Recommended Dose:300 mg single oral dose once daily. Take on an empty stomach at the same time every day, administered continuously until disease progression or intolerable toxicity.
Time: Take at least 1 hour before or 2 hours after meals; missed dose should be skipped if the next scheduled dose is due within 12 hours, no double dose for compensation.
Interaction:For oral administration only. Avoid concomitant use of strong CYP3A4 inhibitors and inducers. Concurrent use with QT-prolonging drugs requires close clinical monitoring.
Side effects: Common mild to moderate reactions: edema, hypoalbuminemia, elevated transaminase, diarrhea, nausea and fatigue. Rare severe adverse reactions include interstitial lung disease, severe skin toxicity and prolonged QT interval; fatal adverse events are extremely rare.

Important Notice

This product shall only be used for post-exposure rabies prophylaxis by professional medical staff. It must be applied combined with rabies vaccine and injected via wound infiltration plus intramuscular routes as specified. Do not administer intravenously or alter the dosage at will. Hypersensitivity monitoring is required throughout the whole injection process.

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