Formulation and specifications: (1) Tablets: 100 mg, 400 mg; (2) Capsules: 50 mg, 100 mg
Indications: For patients with unresectable and/or metastatic KIT mutations in malignant melanoma.
Key points for rational drug use:
1. Imatinib should only be used if the tumor is positive for the C-KIT mutation as determined by a test approved by the State Drug Administration prior to treatment. Immunohistochemical CD117 positivity is not a substitute for KIT mutation gene testing, and imatinib should not be used in patients with KIT wild-type melanoma.
2. The recommended dose for patients with advanced melanoma with KIT mutation is 400 mg; the dose can be increased to 600 mg or 800 mg as prescribed after the progression of 400 mg treatment, and some patients still benefit, but the adverse effects are also aggravated.
3. Common reactions during drug administration include edema, weakness, loss of appetite, skin rash, decreased granulocytes, etc. Blood tests, liver and kidney functions should be performed regularly during drug administration.
4. This product is a substrate of CYP3A4, and the plasma concentration of imatinib is reduced after the simultaneous administration of CYP3A4 inducers, resulting in reduced efficacy.
5. Imatinib should be taken with a meal and a large glass of water. And note: (1) When using the capsule form, for patients who cannot swallow the capsule (including children), 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) Developmental delays have been reported in children and preadolescents receiving 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.