Formulation and Specifications: Capsules: 100 mg
Indications: Treatment of adult patients with locally advanced or metastatic NSCLC who have received prior platinum-containing chemotherapy with a positive transfection rearrangement (RET) gene fusion.
Key points for rational drug use:
1. Positive RET gene fusions must be clearly detected by a well-validated assay prior to treatment.
2. The recommended dose is 400 mg daily until disease progression or intolerable toxicity occurs. It should be taken orally at the same time each day, on an empty stomach, i.e. at least 2 hours before and at least 1 hour after taking this product.
3. If a dose is missed, it should be taken as soon as possible on the same day. Resume the regular daily dosing schedule for this product on the following day. Do not take additional doses if vomiting occurs after taking the drug, but continue with the next dose as scheduled.
4. In case of adverse reactions, the dose of this product should be gradually reduced by 100 mg per dose according to the patient’s tolerance: (1) First dose reduction to 300 mg once daily. (2) Second dose reduction to 200 mg once daily. (3) Third dose reduction to 100 mg once daily. If the patient does not tolerate the 100 mg once daily dose, it should be permanently discontinued.
5. The most common adverse reactions (incidence ≥ 25%) were constipation, hypertension, fatigue, skeletal muscle pain, and diarrhea. The most common grade 3-4 abnormal laboratory findings (incidence ≥ 2%) are decreased lymphocytes, decreased neutrophils, decreased hemoglobin, decreased phosphate, decreased calcium (corrected), decreased sodium, increased AST, increased ALT, thrombocytopenia, and increased alkaline phosphatase. Special attention should be paid to the occurrence of non-infectious pneumonia/interstitial pneumonia.
6. Avoid combination with potent P-glycoprotein and CYP3A co-inhibitors and CYP3A inhibitors or inducers (e.g., voriconazole, phenytoin, carbamazepine, rifampin, etc.).