Formulation and Specifications: Tablets: 15 mg
Indications: Single-agent use in the first-line treatment of patients with EGFR exon 19 deletion mutations or exon 21 L858R substitution mutations in locally advanced or metastatic NSCLC.
Key points for rational drug use:
1. Patients with positive EGFR exon 19 deletion mutation or exon 21 L858R substitution mutation detected by EGFR genetic testing methods approved by the State Drug Administration must be clearly identified prior to drug administration.
2. For patients with positive exon 21 L858R substitution mutation, daclotinib is recommended in preference.
3. Patients are recommended to receive this drug until disease progression or intolerable toxicity occurs.
4. The recommended dose is 45 mg orally, once daily, with or without food. For elderly and frail patients evaluated by clinicians as poorly tolerated, the starting dose may begin at 30 mg orally once daily.
5. Take this product at approximately the same time each day. If a patient vomits or misses a dose, no additional dose or supplemental missed dose should be taken, but the prescribed dose should be taken at the next dosing time.
6. Common adverse reactions to daclotinib are diarrhea, rash, metritis, oral mucositis, and dry skin. Special attention should be paid to the occurrence of interstitial pneumonia.
7. If adverse reactions occur, the dose of this product should be gradually reduced by 15 mg per dose reduction according to the patient’s tolerance: (1) First dose reduction to 30 mg once daily. (2) Second dose reduction to 15 mg once daily. If the patient does not tolerate the 15 mg once-daily dose, it should be permanently discontinued. Temporarily discontinue the product and make an immediate diagnosis of interstitial pneumonia in patients with worsening respiratory symptoms that may indicate interstitial pneumonia (e.g., dyspnea, cough, and fever). If the diagnosis of interstitial pneumonia of any grade is confirmed, discontinue the product permanently.
8. Dose adjustment is not recommended for patients with mild to moderate severe hepatic or mild to moderate renal impairment. The recommended dose of this product for patients with severe renal impairment has not been established.
9. Avoid concomitant use of proton pump inhibitors when taking this product. Topically acting antacids or H2receptor antagonists may be used instead of proton pump inhibitors; if H2receptor antagonists must be taken temporarily, give this product at least 6 hours earlier or after a 10-hour delay.
10. Avoid concomitant use of CYP2D6 substrates when taking this product, as a slight increase in CYP2D6 substrate concentration may produce serious or life-threatening toxicity.