Formulation and specifications: (1) Tablets: 100mg, 400mg; (2) Capsules: 50mg, 100mg
Indications: For the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML) in the chronic, accelerated, or acute phase; for the treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL) in combination with chemotherapy; for the treatment of relapsed or refractory Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL); for the treatment of adult patients with eosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) with a FIP1L1-PDGFRα fusion gene; for the treatment of adult patients with myelodysplastic syndromes/myeloproliferative disorders (MDS/MPD) with platelet-derived growth factor receptor (PDGFR) gene rearrangements The drug is used to treat adult patients with platelet-derived growth factor receptor (PDGFR) gene rearrangement.
Key points for rational drug use: 1.
1. The diagnosis of Philadelphia chromosome-positive or BCR-ABL-positive chronic myeloid leukemia or acute lymphoblastic leukemia, or myeloproliferative neoplasm with PDGFR gene rearrangement must be clearly established prior to drug administration.
2. Baseline evaluation should be done before treatment and hematologic, cytogenetic and molecular biological responses should be monitored regularly during treatment in accordance with relevant disease guidelines.
3. The initial treatment dose should be selected according to different disease types and stages, and the dose should be adjusted during treatment according to efficacy and adverse effects.
4. Common adverse events (>10%) are neutropenia, thrombocytopenia, anemia, headache, dyspepsia, edema, weight gain, nausea, vomiting, muscle cramps, musculoskeletal pain, diarrhea, rash, fatigue, and abdominal pain.
5. Second-generation drug replacement is available when intolerable or resistant due to toxicity during treatment.
*6. Imatinib is used in adults with primary Philadelphia chromosome-positive acute lymphoblastic leukemia (an approved indication in other countries worldwide).
7. This product is a substrate of CYP3A4, and the plasma concentration of imatinib is reduced after concomitant administration of CYP3A4 inducers, resulting in reduced efficacy, and concomitant administration of imatinib with CYP3A4 inducers should be avoided.
8. 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.