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. Patients must obtain a positive ALK result confirmed by an assay approved by the State Drug Administration prior to dosing.
2. Patients are advised to receive this drug until disease progression or intolerable toxicity occurs.
3. The recommended dose is 600 mg orally twice daily with meals. In case of adverse events, the dose of this product should be gradually reduced by 150 mg per dose reduction according to patient tolerance: (1) First dose reduction: 450 mg twice daily. (2) Second dose reduction: 300 mg twice daily; if the patient cannot tolerate the 300 mg twice daily dose, it should be permanently discontinued.
4. Liver function, including ALT, AST and total bilirubin, should be monitored at baseline, biweekly for the first 3 months of treatment, and periodically thereafter.
5. Patients are advised to report any unexplained myalgia, tenderness or weakness and to assess creatine phosphokinase levels, biweekly during the first month of treatment and subsequently as needed in the clinic based on patient-reported symptoms.
6. Patients with confirmed diagnosis of interstitial pneumonia/non-infectious pneumonia should discontinue this product immediately and permanently if no other underlying cause of interstitial pneumonia/non-infectious pneumonia is identified.
7. Patients should be advised to avoid prolonged sun exposure while taking aletinib and for at least 7 days after treatment discontinuation. In addition, patients should be advised to use a broad-spectrum sunscreen and lip balm (SPF ≥ 50) with ultraviolet A (UVA)/ultraviolet B (UVB) protection to prevent possible sunburn.
8. Heart rate and blood pressure should be monitored according to clinical indications. If asymptomatic bradycardia occurs, no dose adjustment is necessary; if a patient experiences symptomatic bradycardia or a life-threatening event, medications known to trigger bradycardia (e.g., antihypertensives) in combination should be evaluated and dose adjusted according to the instructions.
9. Appropriate monitoring is recommended when alectinib is combined with P-glycoprotein or breast cancer resistance protein substrates (e.g., digoxin, dabigatran, methotrexate) with a narrow therapeutic index.
10. No dose adjustment is required when combining alectinib with CYP3A inducers or inhibitors.