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aoyixin limertinib tablets lung cancer 80mg

Description

 Indication & Scope

AoYiXin® Limertinib Tablets treats locally advanced or metastatic non-small cell lung cancer with EGFR T790M mutation positivity, as well as first-line treatment for non-small cell lung cancer carrying EGFR exon 19 deletion or exon 21 L858R sensitizing mutations.

  • Mechanism: It irreversibly binds to and inhibits mutated EGFR tyrosine kinase, blocks the downstream RAS/RAF/MEK/ERK signal transduction pathway, and suppresses the proliferation of tumor cells driven by EGFR mutations.
  • Drug class: Third-generation oral EGFR tyrosine kinase inhibitor, targeted anti-tumor prescription medicine.
  • Clinical use: Serves as second-line treatment for EGFR-TKI resistant non-small cell lung cancer with T790M mutation, and first-line targeted therapy for patients with EGFR sensitizing mutation positive non-small cell lung cancer.
Specification
Generic Name Limertinib Tablets
Brand Name AoYiXin
Ingredient Limertinib Tablets
Dosage Form Tablets
Package 80mg*20 tablets/box
Conditions Treated Locally advanced and metastatic non-small cell lung cancer with EGFR gene mutations
Taboos Patients with severe hypersensitivity to limertinib or any auxiliary ingredients of the preparation; pregnant women due to the risk of embryo and fetal toxicity
Place of origin China
Prescription type Prescription-only
Storage Conditions Store at a temperature not higher than 25°C, seal the container to avoid light and moisture
Manufacturer AoSaiKang Pharmaceutical, Ltd.
Registration Authority National Medical Products Administration (NMPA), China
Approval number H20250004
Approval Date Jan 14, 2025
Shelf Life 36 months

How to use ?

Recommended Dose: 80mg twice a day for first-line treatment, and 160mg twice a day for second-line T790M mutation treatment.

 

Time: The two daily doses are taken at an interval of 12 hours, and continuous medication is maintained until disease progression or intolerable adverse reactions occur.

 

Instructions for use: First-line treatment can be taken with or without food; second-line treatment needs to be taken on an empty stomach, 1 hour before meals or 2 hours after meals. The tablets shall be swallowed whole without crushing or chewing.

 

Interaction: Strong CYP3A4 inhibitors will increase the blood concentration of limertinib, while strong CYP3A4 inducers will reduce its therapeutic effect, and combined use should be avoided.

 

Side effects: Diarrhea, dry skin, paronychia, stomatitis, elevated liver transaminase levels, rare interstitial lung disease, and QT interval prolongation.

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

1.WHO References
2.NMPA
3.FDA
4.EMA

FAQ

What is the primary clinical indication of Limertinib Tablets?

It is used for first-line treatment of EGFR-mutated NSCLC and second-line treatment for EGFR T790M-mutated advanced non-small cell lung cancer.

How does Limertinib Tablets exert its anti-tumor mechanism?

It irreversibly inhibits mutant EGFR kinase and blocks downstream oncogenic signaling pathways to suppress tumor proliferation.

What are the main adverse reactions of Limertinib Tablets?

Common side effects include diarrhea, dry skin, paronychia, elevated liver enzymes, and rare interstitial lung disease.

What are the contraindications for Limertinib Tablets?

It is contraindicated in patients with hypersensitivity and pregnant women due to embryo-fetal toxicity risks.

AoYiXin® | Limertinib Tablets | Lung Cancer | DengYueRX

INN: Limertinib Tablets
Indications: Lung cancer
Dosage Form: Tablets
Strength: 80mg/tablet

Low MOQ

WHO-GMP

Worldwide Delivery

Compliance and Regulatory Documents

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