Formulation and Specifications: Tablets: 50 mg
Indications: Treatment of adult patients with advanced gastrointestinal mesenchymal tumors who have received 3 or more prior tyrosine kinase inhibitors (including imatinib).
Rational Dosing Points:
1. The recommended daily oral dose is 150 mg, which may be given with food or on an empty stomach until disease progression or intolerable toxicity occurs.
2. If a lower dose is required due to adverse reactions, the recommended dose is 100 mg once daily; if the patient is unable to tolerate 100 mg once daily, the drug should be permanently discontinued.
3. This indication was granted conditional approval based on the results of the 4th line gastrointestinal mesenchymal tumor INVICTUS study; full approval of this indication will be contingent upon clinical benefit in Chinese patients from the ongoing ZL-2307-002 trial.
4. No dose adjustment is required in patients with mild hepatic impairment; the recommended dose has not been established in patients with moderate to severe hepatic impairment.
5. The safety and efficacy of this product in pediatric patients is unknown; the number of patients aged ≥65 years included in clinical studies is not sufficient to adequately demonstrate whether there is a drug response difference between older and younger patients.
6. Common adverse reactions must be noted during administration, including alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythema syndrome, and vomiting; the most common serious adverse reactions are abdominal pain, anemia, nausea, and vomiting.
7. Avoid combining with potent CYP3A inducers and inhibitors.