Formulation and Specifications: Hard Capsules: 25mg, 100mg
Indications: For the treatment of ALK-positive locally advanced or metastatic NSCLC patients who have progressed after prior treatment with crizotinib or who are intolerant to crizotinib.
Key points for rational drug use:
1. ALK positivity as detected by an NDA-approved kinase assay for mesenchymal lymphoma must be clearly available prior to dosing.
2. The recommended dose is 225 mg once daily, administered orally at the same time each day, on an empty stomach or with food. If one dose is missed and more than 12 hours before the next dose, the patient should take the missed dose. If vomiting occurs during treatment, the patient should not take the additional dose, but should continue with the next scheduled dose.
3. If Grade 3-4 adverse reactions occur during the application of this product, the dose should be adjusted as follows: the starting dose of this product is 225mg once a day; the first dose reduction is adjusted to 200mg once a day; if still not tolerated, another dose reduction is adjusted to 150mg once a day; if 150mg once a day is still not tolerated, this product should be discontinued.
4. The main adverse reactions during the use of the drug is a transient drug rash, mainly manifested as grade 1 to 2 rash and pruritus, the median duration of patients with rash is 21.5 days. In addition to rash, the common adverse reactions were grade 1-2 ALT/AST elevation and grade 1-2 gastrointestinal discomfort.
5. Avoid combination with strong inducers or strong inhibitors of CYP3A4.