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Trade name: Gleevec hotline&==&Ms. Zhang Common name: Imatinib mesylate
English name: G
[Main ingredient] Imatinib mesylate Ni.
[Properties] This product is a capsule, the content is white to off-white powder.
[Indications] It is used to treat patients with malignant gastrointestinal stromal tumors (GT) that cannot be surgically resected or have metastasized in patients with chronic myelogenous leukemia in blast phase, accelerated phase or chronic phase after failure of interferon therapy.
[Usage and Dosage] For patients in the blast phase and accelerated phase of chronic myelogenous leukemia, the recommended dose of imatinib mesylate is g/day. For patients in the chronic phase who have failed interferon therapy, as well as those who cannot be surgically resected or develop For patients with metastatic malignant gastrointestinal stromal tumors (GT), the recommended dose is g/day, which should be taken orally once a day. It is advisable to take the medicine with meals and drink a large glass of water. As long as it is effective, it should be continued. If the blood picture permits and there are no serious adverse drug reactions, the dose may be considered to be increased from g/day to g/day, or from g/day to g/day (g, divided into doses) under the following circumstances: disease progression, treatment of at least After several months, satisfactory hematological response could not be obtained, and the hematological response that had been achieved disappeared again. The dose must be adjusted in the following circumstances: If serious non-hematological adverse reactions (such as severe water retention) occur during treatment, the drug should be discontinued until the adverse reactions disappear, and then the dose will be adjusted according to the severity of the adverse reactions. Dosage adjustment in case of severe liver toxicity: If the increase in bilirubin exceeds the upper limit of the normal range or the increase in transaminases exceeds the upper limit of the normal range, the drug should be discontinued until the above indicators drop to or below the upper limit of the normal range respectively. Dose adjustment in neutropenia or thrombocytopenia: Acceleration phase or blast phase: If severe neutropenia and thrombocytopenia occur (neutrophil &t.&t and/or platelet &t&t, it is recommended that the dose be reduced to g/day .If the blood cells continue to decrease for weeks, the dose should be further reduced to g/day. If the blood cells continue to decrease for weeks, it is advisable to discontinue the drug until the neutrophils &g(grtrtht).&t and platelets&g(grtrtht)&t. The dose is g when used again. /Day.&hPatients in the chronic phase after interferon treatment failure: it is advisable to discontinue the drug when neutrophils&t.&t and/or platelets&t&t, and restart only when neutrophils&g(grtrtht).&t and platelets&g(grtrtht)&t To resume medication, the dose is g/day. If neutrophils or platelets are reduced to the above values again, the dose is reduced to g/day when medication is resumed. Children and adolescents: No patients under the age of 1 have used imatin mesylate. Clinical data on the safety and efficacy of imatinib treatment. Dosage in patients with liver failure: The plasma concentration of imatinib mesylate can increase in patients with liver damage, so these patients should be cautious when using this drug. Currently, there is no Clinical data on the use of imatinib mesylate in patients with hepatic impairment do not allow for dose adjustment recommendations. Dosage in renal failure and elderly patients: Creatinine clearance is known to decrease with age, and age-related changes in imatinib mesylate The pharmacokinetics of imatinib have no significant impact. Since clinical trials have not been conducted in patients with renal impairment, no dosage adjustment recommendations can be made.
[Adverse Reactions] Most patients are taking imatinib while taking it. Some adverse reactions will occur during matinib, but most of them are mild to moderate. Considering that the disease itself also produces symptoms, it is often difficult to clarify their causal relationship. During the clinical trial, the clinical trial was stopped due to drug-related adverse reactions. Drug users only account for % of patients in the chronic phase of chronic myeloid who fail interferon treatment, about % in the accelerated phase, and % in the blast phase of chronic myeloid. The most common adverse events related to drug treatment are mild nausea (%), Vomiting, diarrhea, myalgia, and muscle cramps are all easily managed adverse events. Edema and water retention were reported in all studies, with incidence rates of % and %, respectively, and severe cases of edema and water retention in most patients. Manifested as periorbital and lower limb edema, pleural effusion, ascites, pulmonary edema and rapid weight gain have also been reported. At this time, the medication is usually suspended and diuretics or certain supportive treatments are given. Some patients are in serious or even life-threatening conditions. There are cases Patients with chronic myeloid blast died due to complex clinical conditions complicated by pleural effusion, congestive heart failure, and renal failure. The incidence of these adverse reactions is related to the dose, and is more common at >g(grtrtht)g per day.
[ Contraindications] It is prohibited for those who are allergic to the active substances of this medicine or any excipients.
[Notes] The initial treatment should be carried out by a physician with experience in the treatment of chronic myelogenous leukemia. About % of people taking ethyl mesylate Patients with matinib develop severe water retention (pleural effusion, edema, pulmonary edema, and ascites). Therefore, it is recommended to monitor weight regularly. If weight increases unexpectedly and rapidly during medication, detailed examination should be performed, and appropriate supportive treatment and treatment should be taken if necessary. Treatment measures. Water retention can aggravate or lead to heart failure. Currently, there is no experience in the clinical use of imatinib mesylate in patients with severe heart failure (according to the New York Heart Association classification). Use this drug with caution in these patients. The dose of imatinib mesylate may be increased in patients with liver failure. Patients with liver damage should use this drug with caution. Long-term clinical data on the safety and effectiveness of this drug are limited. Preclinical studies have shown that imatinib mesylate does not readily pass through the blood-brain barrier. It has not been studied in humans. It is advisable to check the complete blood count every week in the first month of imatinib mesylate treatment, once a week in the first month, and then as needed (such as monthly checks). If severe neutropenia or thrombocytopenia occurs, the dose should be adjusted. Liver function (including transaminases, bilirubin, and alkaline phosphatase) should be checked before starting treatment, and then checked monthly or based on clinical conditions, and the dose should be adjusted if necessary. Effects on the abilities of the driver and machine operator There is no information on possible effects on the abilities of the driver or machine operator.
[Drug use in pregnant and lactating women] Pregnancy: Animal studies have shown that this drug has toxic effects on the reproductive system, but there is currently a lack of data on its use in pregnant women, and the possible toxicity to the fetus is currently unknown. It should not be used during pregnancy unless the possible benefits outweigh the harm to the fetus/infant. If imatinib mesylate is taken during pregnancy, you 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. Breastfeeding: In animal experiments, imatinib mesylate and its metabolites were excreted in breast milk in large quantities, but no human studies have been conducted. Women taking imatinib mesylate should not breastfeed.
【Pediatric Medication】In individual samples, the plasma concentration of children can be increased by .
[Drug use in elderly patients] It is known that creatinine clearance can decrease with age, but age has no significant impact on the pharmacokinetics of imatinib mesylate.
【Drug Overdose】There is little experience with doses exceeding 1 g, and there are no case reports of overdose. If overdose occurs, the patient should be closely observed and given appropriate supportive care.
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| Company Name： |
Beijing Health Medicine |
Company type： |
企业单位 () |
| location： |
Beijing |
Company Size： |
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| Registered capital： |
unfilled |
Registration year： |
2010 |
| Data certification： |
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| Security deposit： |
Already paid 0.00 元 |
| Business Scope： |
Beijing Shanghai Guangzhou Shanghai Wuhan |
| major business： |
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