Formulation and specifications: Capsules: 200mg, 250mg
Indications:
1. Treatment of patients with locally advanced or metastatic NSCLC who are mesenchymal lymphoma kinase (ALK)-positive.
2. Treatment of ROS1-positive patients with advanced NSCLC.
Key points for rational drug use:
1. ROS1-positive or ALK-positive detected by a test approved by the State Drug Administration must be clearly available before drug administration.
2. Common liver function abnormalities and visual abnormalities must be noted during dosing. Patients should be tested weekly during the first two months of treatment initiation and monthly thereafter, and patients with liver injury should be treated with caution with crizotinib.
3. The recommended dose is 250 mg orally, twice daily, with or without food. In case of CTCAE (version 4.0) grade 3 or 4 adverse events, dose reduction is required as follows: (1) First dose reduction: 200 mg orally twice daily. (2) Second dose reduction: orally, 250 mg once daily; if 250 mg of crizotinib capsules orally once daily is still not tolerated, discontinue permanently.
4. Combination of strong CYP3A inhibitors or strong CYP3A inducers should be avoided. If combination of strong CYP3A inhibitors cannot be avoided, the dose of crizotinib should be reduced. Combination with moderate CYP3A inhibitors should be used with caution. Crizotinib capsules may prolong the QTc interval; avoid combining with drugs that prolong the QTc interval. Crizotinib capsules can cause bradycardia; avoid combining with drugs that can cause bradycardia.
※5. Based on the results of the Profile1001 study and the 2021 edition of the NCCN guidelines, crizotinib is indicated for patients with advanced NSCLC with exon skipping mutations in cMET14.