Imatinib Mesylate Tablets

Imatinib can inhibit Bcr-Ab1 tyrosine kinase at the cellular level both in vivo and in vitro, and can selectively inhibit the proliferation and induce apoptosis of fresh cells from Bcr-Ab1 positive cell lines, Philadelphia chromosome positive (Ph) chronic myeloid leukemia (CML) and acute lymphoblastic leukemia patients. (See the instructions inside the package for details)

The active ingredient of this product is imatinib mesylate. Chemical name: 4-[(4-methyl-1-piperazinyl)methyl]-N-[4-methyl-3-[4-(3-pyridinyl)-2-pyrimidinyl]amino]-phenyl]benzamide methanesulfonate. Molecular weight: C29H31N7O·CH4O3S

This product is a dark yellow to brownish yellow biconvex film-coated tablet.

It is used to treat the chronic phase, accelerated phase or blast phase of Philadelphia chromosome-positive chronic myeloid leukemia (PhCML). (See the inner package insert for details).

Treatment should be performed by a physician who has experience in treating chronic myeloid leukemia or GIST. Imatinib mesylate should be taken with meals and a large glass of water. Usually adults take 400 mg or 600 mg once a day, and the daily dose is 800 mg, which is 400 mg twice a day (in the morning and evening). Children and adolescents take it once or twice a day (morning and evening). (See the instructions inside the package for details)

Not yet clear.

Not yet clear.

Precautions for children: For children over 3 years old, please refer to [Usage and Dosage]. The data mainly come from foreign children's research data, and the safety and effectiveness data of the drug in the Chinese pediatric population are limited. There is no experience with the drug in children under 3 years old. Precautions for pregnancy and lactation: Pregnant animal studies have shown that this drug has reproductive toxicity (see the reproductive toxicity section of toxicology studies). There is currently a lack of information on the use of imatinib by pregnant women, and the possible toxicity to the fetus is currently unknown. Unless it is absolutely necessary, it should not be used during pregnancy. If imatinib mesylate is taken during pregnancy, it must be informed of the possible harm to the fetus. Women of childbearing age should be advised to use effective contraception while taking imatinib mesylate. Lactation Imatinib and its metabolites can be secreted into human breast milk. The concentration ratios of imatinib and its metabolites in breast milk plasma are 0.5 and 0.9, respectively, indicating that the proportion of metabolites entering breast milk is higher. According to the combined concentration of imatinib and its metabolites and the maximum daily breast milk intake of infants, the overall drug exposure of infants is very low, accounting for only the therapeutic dose. Note for the elderly: The age-related decrease in creatinine clearance has no significant effect on the pharmacokinetics of imatinib mesylate. Elderly patients or patients with a history of heart disease who are treated with this product should first measure the left ventricular ejection fraction (LVEF). During treatment, if the patient has obvious symptoms of heart failure, a comprehensive examination should be conducted and corresponding treatment should be given according to the clinical symptoms.

Drugs that can change imatinib plasma concentrations CYP3A4 inhibitors: After healthy subjects took a single dose of ketoconazole (CYP3A4 inhibitor) at the same time, the drug exposure of imatinib increased significantly (the average maximum plasma concentration (Cmax) and the area under the imatinib curve (AUC) increased by 26% and 40%, respectively). There is no experience of taking it at the same time with other CYP3A4 inhibitors (such as itraconazole, erythromycin and clarithromycin). (See the inner package insert for details).

Store in sealed, dry place.

0.1g (based on C29H31N7O)

24 months

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

• Founded in:

  1995-07-26

• Address:

  Lianyungang Economic and Technological Development Zone, Jiangsu Province

• Tax NO.:

  913207006083959289

• Registered Funds:

  1,000,000,000 Yuan

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