Formulation and specifications: Tablets: 40mg, 80mg
Indications:
1. For postoperative adjuvant therapy in patients with stage IB to IIIA EGFR gene exon 19 deletion or exon 21 L858R substitution mutation in NSCLC with or without adjuvant chemotherapy at the discretion of the physician.
2. First-line therapy for adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion mutations or exon 21 L858R substitution mutations.
3. Treatment of adult patients with locally advanced or metastatic NSCLC with disease progression on or after prior treatment with EGFR-TKI and positive EGFR-T790M mutation confirmed by testing.
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 before postoperative adjuvant or first-line dosing.
2. For locally advanced or metastatic patients with disease progression during or after prior EGFR-TKI treatment, EGFR-T790M mutation must be clearly detected by an assay approved by the State Drug Administration prior to dosing.
3. Ocitinib is recommended as adjuvant therapy after complete tumor resection in patients with EGFR mutation-sensitive stage IB-IIIA NSCLC.
4. Ositinib is recommended for patients with EGFR mutation-positive brain metastases or meningeal metastases.
5. The recommended dose of oseltinib is 80 mg orally once daily, either with a meal or on an empty stomach. Dosing may be suspended or reduced depending on the safety and tolerability of the individual patient. If a dose reduction is required, the dose should be reduced to 40 mg orally once daily.
6. Common skin reactions and diarrhea must be noted during dosing. Prolonged ECG QTc interval should be noted, and special attention should be paid to the occurrence of interstitial pneumonia.
7. Avoid combining with CYP3A4 strong inducers, breast cancer resistance protein substrates and P-glycoprotein substrates.