Icotinib Hydrochloride Tablets

Icotinib is a selective epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. The half effective concentration (IC50) of icotinib in inhibiting EGFR tyrosine kinase activity is 5nM. Among the 88 kinases tested, icotinib at a concentration of 500nM only had a significant inhibitory effect on EGFR wild type and its mutant type, and had no inhibitory effect on other kinases, indicating that icotinib is a highly selective EGFR kinase inhibitor. In vitro studies and animal experiments have shown that icotinib can inhibit the proliferation of a variety of human tumor cell lines.

The main ingredient is icotinib hydrochloride. Chemical name: 4-[(3-ethynylphenyl)amino]-quinazolino[6,7-b]-12-crown-4 hydrochloride Molecular weight: C22H21N3O4·HCl

Conmena is a brown-red film-coated tablet that appears off-white after the coating is removed.

For second-line treatment of advanced non-small cell lung cancer.

125 mg/time, 3 times/day.

The safety assessment of icotinib is based on research data from 312 patients with advanced NSCLC, including 224 patients who received 125 mg three times daily. Overall, icotinib was well tolerated. The most common adverse reactions in the Phase III clinical trial (ICOGEN) were rash (39.5%), diarrhea (18.5%), and elevated aminotransferases (8.0%). The vast majority were grade I to II, generally seen within 1-3 weeks after taking the drug, usually reversible, without special treatment, and can disappear on their own. Table 1 lists adverse reactions reported in the ICOGEN trial with an incidence of ≥1%.

Not yet clear

Precautions for children: There is currently no data on the safety and efficacy of Conmana for children or adolescents under 18 years of age, so it is not recommended. Precautions for pregnancy and lactation: 1. There is currently no clinical data on the use of Conmana in pregnant women. Animal experimental results show that when high doses of icotinib, which can be toxic to the mother, are given during the organogenesis period, an increase in the stillbirth rate can be observed in rats, and some fetal rats have congestion on the back of the neck or around the eyes. No abnormal appearance, visceral malformations, or ossification rate were observed in rats. It is recommended that women of childbearing age avoid pregnancy during treatment with Conmana. 2. Use during lactation: There is currently no clinical data on the use of Conmana in lactating women. It is not clear whether icotinib or its metabolites are secreted into human milk. It is recommended that lactating mothers stop breastfeeding during treatment with Conmana. Precautions for the elderly: There is currently no clinical research data specifically for elderly patients. In the ICOGEN study, 19.0% of the subjects were aged 65 years or older. Compared with subjects under 65 years old, the average medication time (days) of patients over 65 years old was slightly higher than that of the group under 65 years old, and the incidence of rash, diarrhea and elevated aminotransferase was slightly lower than that of the latter, with similar efficacy.

At present, formal drug interaction studies have not been conducted for icotinib. In vitro studies have shown that icotinib is mainly metabolized by CYP2C19 and CYP3A4 of the cytochrome P-450 monooxygenase system, and has a significant inhibitory effect on CYP2C9 and CYP3A4, and no significant induction effect on rat liver P450 enzymes was found.

Keep in a light-proof and airtight container.

125mg

24 months

Betta Pharmaceuticals Co., Ltd.

• Founded in:

  2003-01-07

• Address:

  No. 355, Xingzhong Road, Economic and Technological Development Zone, Linping District, Hangzhou City, Zhejiang Province

• Tax NO.:

  913301007463034461

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  418.485885 yuan

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