Formulation and specifications: Capsules: 12.5mg, 25mg, 37.5mg, 50mg
Indications:
1. Patients with gastrointestinal mesenchymal tumors who have failed or are intolerant to imatinib therapy.
2. Adult patients with unresectable, metastatic highly differentiated progressive pancreatic neuroendocrine tumors.
Key points for rational drug use:
1. The maximum recommended daily dose for the treatment of gastrointestinal mesenchymal tumors is 50 mg, taken for 4 weeks and discontinued for 2 weeks, without correlation with food intake; if it must be combined with a CYP3A4 inhibitor, the dose can be reduced to 37.5 mg; if it must be combined with a CYP3A4 inducer, the maximum dose does not exceed 87.5 mg. For pancreatic neuroendocrine tumors, the recommended dose is 37.5 mg, taken orally Once daily, continuous dosing with no discontinuation period. It can be taken with or without food.
2. Common adverse reactions must be noted during administration, such as leukopenia, diarrhea, malaise, and hand-foot syndrome; potentially serious adverse reactions are hepatotoxicity, left ventricular dysfunction, prolonged QTc interval, bleeding, hypertension, and thyroid insufficiency.
3. Discontinuation is recommended if clinical signs of congestive heart failure are present; patients without clinical evidence of congestive heart failure but with an ejection fraction <50% and an ejection fraction below 20% of baseline should also be discontinued and/or dose reduced.
4. May prolong the QTc interval in a dose-dependent manner. It should be used with caution in patients with a known history of QTc interval prolongation, in patients taking antiarrhythmic drugs, or in patients with appropriate underlying cardiac disease, bradycardia, and electrolyte disturbances.
5. If severe hypertension occurs during use, use should be suspended until the hypertension is controlled.
6. This product is hepatotoxic and may lead to liver failure or death. The occurrence of liver failure has been observed in clinical studies (incidence <1%). Liver function (ALT, AST, bilirubin) should be monitored prior to treatment initiation, during each treatment cycle, and as clinically indicated. Treatment should be discontinued when grade 3 or 4 drug-related hepatic adverse reactions occur and discontinued if recovery is not possible.