Formulation and Specifications: Capsules: 150 mg
Indications: Treatment of ALK-positive patients with locally advanced or metastatic NSCLC.
Key points for rational drug use:
1. ALK positivity as detected by the State Drug Administration-approved mesenchymal lymphoma kinase assay must be clearly available prior to dosing.
2. The recommended dose of this product is 450 mg/dose once daily, administered orally at the same time each day, and the drug should be taken with food. Depending on the safety or tolerability of the individual patient, it may be necessary to temporarily interrupt the use of this product or adjust the dose downward during the course of treatment, and the daily dose of this product should be gradually reduced by 150 mg. Early recognition of adverse drug reactions and early administration of standard supportive therapy should be observed. For patients who cannot tolerate a daily dose of 150 mg with meals, the product should be discontinued.
Attention should be paid to gastrointestinal adverse reactions, hepatotoxicity, interstitial pneumonia/non-infectious pneumonia, cardiac arrhythmias, hyperglycemia and other adverse reactions during drug administration.
4. Combination of strong CYP3A inhibitors should be avoided during treatment with this product. If concomitant use of potent CYP3A inhibitors (including but not limited to ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone) is unavoidable, the dose of ceritinib should be reduced by approximately one-third and approximated as a multiple of the 150 mg dose specification. When administration of CYP3A inhibitors is discontinued, resume the dose administered prior to the use of strong CYP3A inhibitors.
5. Data from in vitro studies indicate that this product is a substrate for the efflux-type transporter protein P-glycoprotein. If this product is used in combination with drugs that inhibit P-glycoprotein, it may lead to an increase in the concentration of this product. Caution should be exercised when combining P-glycoprotein inhibitors and careful monitoring for adverse effects.
*6. Based on a phase II clinical study published in JCO (NCT01964157), ceretinib may be an option for NSCLC patients with ROS1 rearrangement after treatment with chemotherapy.