Formulation and specifications: (1) Tablets: 100mg, 400mg; (2) Capsules: 50mg, 100mg
Indications:
1. For the treatment of adult patients with unresectable and/or metastatic gastrointestinal mesenchymal tumors.
2. For the adjuvant treatment of adult patients with C-Kit (CD117)-positive gastrointestinal mesenchymal tumors at significant risk of recurrence after surgical resection.
Rational Dosing Points:
1. The recommended dose is 400 mg/d, all administered orally once daily, preferably with a meal. Common adverse effects such as fluid retention, nausea, diarrhea, rash, neutropenia, thrombocytopenia, anemia, painful muscle spasms, and hepatic impairment must be noted during dosing.
2. Monitor liver function closely.
3. If satisfactory results are not obtained after treatment, the dose may be increased to 0.6-0.8 g per day if there are no serious adverse drug reactions; if the patient continues to benefit from this drug, he/she may continue to receive this drug.
4. Patients with potentially resectable gastrointestinal mesenchymal tumors may also benefit from neoadjuvant treatment with imatinib.
5. Imatinib is a substrate for CYP3A4, and concurrent administration of CYP3A4-inducing agents reduces the plasma concentration of imatinib, resulting in reduced efficacy.
6. Imatinib should be taken with a meal and a large glass of water. (1) When using the capsule form, for patients (including children) who cannot swallow the capsule, the drug inside the capsule can be dispersed in water or apple juice. When using tablets, the tablets can be dispersed in water or apple juice without gas (approximately 50 ml for 100 mg tablets and 200 ml for 400 mg). The suspension should be stirred and the tablets should be taken as soon as they disintegrate completely. (2) If a serious non-hematological adverse reaction (such as severe fluid retention) occurs during treatment with imatinib, the drug should be discontinued until the adverse reaction resolves, and then the dose should be adjusted according to the severity of that adverse reaction. (3) Studies on the use of imatinib in children over 3 years of age are mainly derived from data from foreign pediatric studies, and data on the safety and efficacy of the drug in the Chinese pediatric population are limited. There is no experience with the use of imatinib in children under 3 years of age. (4) Growth retardation has been reported in children and prepubescent adolescents treated with imatinib. The long-term effects of extended treatment with imatinib on development in children are not known at this time. Therefore, close monitoring of the development of children on imatinib is recommended.