Rare disease

【Product name】Imatinib

[English common name]GLEEVEC

[Chinese common name]Imatinib

[English name]Imatinib intermediates, imatinib

[Chinese other name]Imatinib intermediate, imatinib

[indications]
Imatinib mesylate capsule: for treatmentChronic myeloid leukemia(CML) chronic phase, accelerated phase, or chronic phase after failure of alpha-interferon therapy; malignancy that cannot be surgically removed or metastasizedGastrointestinal stromal tumor (GIST)patient.
Imatinib mesylate tablets: for the treatment of chronic chromosome patients with chronic myeloid leukemia (CML) in Philadelphia, in the blast phase, accelerated phase, or chronic phase after failure of alpha-interferon therapy.
Adult patients for the treatment of malignant gastrointestinal stromal tumors (GIST) that cannot be removed and/or metastasized.

【Dosage】
Imatinib mesylate capsule: starting dose: for patients with blast crisis and accelerated phase of chronic myeloid leukemia, the recommended dose of imatinib mesylate is 600 mg/day; for chronic patients who have failed interferon therapy, and For patients with malignant gastrointestinal stromal tumors (GIST) who cannot be surgically removed or metastasized, the recommended dose is 400 mg/day, which is taken once a day. It is advisable to take the medicine at mealtime and drink a large glass of water. It should be taken continuously.
If the blood picture permits, there is no serious adverse drug reaction, the dose can be considered to increase from 400mg / day to 600mg / day, or from 600mg / day to 800mg / day (400mg, divided into 2 times) in the following cases: disease progression, treatment A satisfactory hematologic response was not obtained after at least 3 months, and the hematologic response that had been obtained disappeared again.
The dose must be adjusted in the following cases: if a serious non-hematologic adverse reaction (such as severe water retention) occurs during the treatment, the drug should be discontinued until the adverse reaction disappears, and then the dose is adjusted according to the severity of the adverse reaction.
Dose adjustment in severe liver toxicity: If the bilirubin rises more than 3 times the upper limit of the normal range or the transaminase rises more than 5 times the upper limit of the normal range, the drug should be discontinued until the above indicators fall to 1.5 or 2.5 times the upper limit of the normal range. the following.
Adjustment of dose during neutropenia or thrombocytopenia: accelerated or blast phase: if severe neutrophils and thrombocytopenia occur (neutrophils <0.5×109/L and/or platelets<10×109/L The recommended dose is reduced to 400 mg / day. If the blood cells continue to decrease for 2 weeks, further reduce the dose to 300 mg / day, if the blood cells continue to decrease for 4 weeks, it is advisable to stop the drug until neutrophils ≥ (greater than or equal to ) 1.0 × 109 / L and platelets ≥ (greater than or equal to) 20 × 109 / L. When used again, the dose is 300 mg / day.
Patients with chronic phase after failure of α-interferon therapy: neutrophils <1.0×109/L and/or platelets <50×109/L should be discontinued, only in granulocyte ≥ (greater than or equal to) 1.5 When x109/L and platelet ≥ (greater than or equal to) 75×109/L, the dosage is 400 mg/day. If the neutrophils or platelets are reduced to the above values, the dosage will be restored. Reduced to 300 mg / day.
Children and adolescents: There are no clinical data on the safety and efficacy of imatinib mesylate in patients under 18 years of age.
Dosage in patients with liver failure: The plasma concentration of imatinib mesylate can be increased in patients with liver damage, so these patients should be cautious when using this drug. There is no liver damage in patients with liver damage. Nie's clinical data, no suggestion for dose adjustment.
Renal failure and dose in elderly patients: creatinine clearance is known to decrease with age, and age has no significant effect on the pharmacokinetics of imatinib mesylate, as it has not been performed in patients with impaired renal function. Clinical trials, so it is not possible to propose a dose adjustment.
Imatinib mesylate tablets: starting dose: The initial treatment should be performed by a physician with experience in treating chronic myelogenous leukemia or GIST.
The product should be taken orally, and it is advisable to take the medicine while eating and drink a large glass of water. Usually adults once a day. Children and adolescents take it once or twice a day (morning and evening).
Patients (children) who cannot swallow tablets can disperse the tablets in water or apple juice. It is recommended that pregnant and lactating women avoid contact with skin or eyes when inhaling capsules, or inhalation (see pregnant and lactating women), and wash hands immediately after touching open capsules.
- therapeutic dose of CML patients
adult
The recommended dose for patients in the chronic phase is 400 mg/day, and for the blast phase and accelerated phase, it is 600 mg/day.
As long as it is effective, it should be taken continuously.
If the blood picture permits, there is no serious adverse drug reaction, the dose can be considered to increase from 400 mg / day to 600 mg / day, or from 600 mg / day to 800 mg / day (400 mg, orally, 2 times) Taking): The disease has not been able to obtain a satisfactory hematologic response after at least 3 months of treatment, and the hematological response has disappeared.
Children and adolescents over 3 years old
So far, children have limited experience in medication. According to the adult dose, the recommended daily dose is: chronic phase 260mg / m2 (maximum dose: 400mg), accelerated phase and blast phase 340mg / m2 (maximum dose: 600mg), the daily recommended dose for children, the calculated dose is generally Should be close to or around 100mg, the dose for children under 12 should generally be as close as possible or around 50mg. There is no experience in treating children under 3 years of age.
- therapeutic dose of GIST patients
For patients with malignant GIST who cannot be removed and/or metastasized, the recommended dose for this product is 400 mg/day.
A satisfactory response was not obtained after treatment. If there were no adverse drug reactions, the dose could be considered to increase from 400 mg/day to 600 mg/day. Treatment time:
For patients with GIST, the product should be treated continuously unless the condition progresses.

[Storage]
Imatinib mesylate capsule: should be kept below 30 °C.
Imatinib mesylate tablets should be kept below 30 °C.

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