Icotinib(盐酸埃克替尼片)

Introduction of Icotinib

As China's first domestically developed EGFR-targeted drug for lung cancer, Icotinib Hydrochloride Tablets has broken the market monopoly of imported targeted drugs following its launch, greatly improved the accessibility of targeted therapy for lung cancer, and provided domestic patients with EGFR-sensitive mutant non-small cell lung cancer (NSCLC) an efficacious, safe and cost-effective localized treatment option.

Indications

1、Icotinib Hydrochloride Tablets as monotherapy is indicated for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring sensitive mutations in the epidermal growth factor receptor (EGFR) gene.

2、Icotinib Hydrochloride Tablets as monotherapy may be tried for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed at least one prior chemotherapy regimen, where prior chemotherapy mainly refers to platinum-based combination chemotherapy.

3、Icotinib Hydrochloride Tablets as monotherapy is indicated for the adjuvant therapy after surgery in patients with Stage II-IIIA non-small cell lung cancer (NSCLC) harboring sensitive mutations in the epidermal growth factor receptor (EGFR) gene.

This product is not recommended for patients with EGFR wild-type non-small cell lung cancer.

Overview

Dosage and Administration

The recommended dose of icotinib is 125mg (1 tablet) three times daily. Administer orally, either on an empty stomach or with food. High-calorie food may significantly increase drug absorption.

Adjuvant therapy after surgery

The recommended dose is 125mg (1 tablet) three times daily, administered orally either on an empty stomach or with food. High-calorie food may significantly increase drug absorption. Continue medication until disease recurrence, onset of intolerable toxicity, or completion of 2 years of treatment.

Dose Adjustment

In patients who develop intolerable adverse reactions such as rash and diarrhea, drug administration may be suspended (for 1 to 2 weeks) until symptoms are relieved or resolved, followed by resumption of the dose of 125mg (1 tablet) three times daily. For patients with mild elevations of aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST] below 100IU/L), medication may be continued with close monitoring. For patients with significant aminotransferase elevations (ALT and AST above 100IU/L), drug administration may be suspended with close monitoring of aminotransferase levels; resumption of administration is allowed when aminotransferase levels recover (both ALT and AST below 100IU/L or return to the normal range).

Analysis of plasma drug concentration data in patients of different ages and genders demonstrated that plasma drug concentrations are not affected by factors such as age and gender; therefore, dose adjustment based on age or gender is not recommended.

Special Populations

No clinical study results are currently available for pediatric patients or pregnant women. Clinical studies in elderly patients and patients with hepatic or renal insufficiency are ongoing.

Contraindications

Contraindicated in patients with hypersensitivity to the active ingredient of this product or any of its excipients.

Adverse Reactions

According to data from the ICOGEN study, the most common adverse reactions associated with this medicinal product include: rash (occurring in approximately 40% of patients), diarrhea (approximately 18.5%), and elevated hepatic aminotransferases (approximately 8%). The vast majority of these reactions are mild to moderate (Grade 1-2) and typically occur within 1 to 3 weeks after initiation of treatment. Most of these adverse effects resolve spontaneously and gradually abate without the need for specific treatment.

Use in Special Populations

Pregnant and Lactating Women

Pregnancy

No clinical data are available on the use of this product in pregnant women to date. Animal experimental results show that high doses of icotinib, which cause maternal toxicity when administered during the organogenesis period, result in an increased rate of stillbirths in rats, and ecchymosis is observed on the nape, back or periorbital area of some fetal rats. No external malformations, visceral malformations or abnormal ossification rate are found in rats.

Females of childbearing potential are advised to avoid pregnancy during treatment with this product.

Lactation

No clinical data are available on the use of this product in lactating women to date. It is unknown whether icotinib or its metabolites are excreted into human milk.

Nursing mothers are advised to discontinue breastfeeding during treatment with this product.

Pediatric Use

No data on the safety and efficacy of this product in pediatric or adolescent patients under 18 years of age are currently available, and its use is therefore not recommended.

For more detailed drug information, please consult the official package leaflet.

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