Befotertinib Application Scope

1. First-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 L858R mutations.
2. Treatment of adult patients with locally advanced or metastatic NSCLC who previously received EGFR-TKI therapy and have disease progression, and in whom EGFR T790M mutation is confirmed.

Befotertinib Characteristics

Ingredients: Befotertinib
Properties: Light yellow to yellow solid
Packaging Specification: Hard capsules, 25 mg and 50 mg strengths
Storage: Store at room temperature; no special storage conditions required
Expiry Date: Refer to the date printed on the outer package; shelf life is as indicated by the manufacturer
Executive Standard: Chinese National Drug Standard as approved by NMPA
Approval Number: China NMPA Approval Nos. 国药准字 H20230011 / H20230012
Date of Revision: See the latest approved package insert for revision date
Manufacturer: Betta Pharmaceuticals Co., Ltd. (Hangzhou, China)

Guidelines for the Use of Befotertinib

Dosage and Administration:
- Recommended Dose:
  - Start with 75 mg orally once daily for the first 21 days.
    If no ≥Grade 2 thrombocytopenia or ≥Grade 2 headache occurs, increase to 100 mg once daily from Day 22 onward.
  - Continue until disease progression or unacceptable toxicity.
- Administration: Take orally at approximately the same time each day, with or without food.
- Missed Dose: If a dose is missed and more than 12 hours remain before the next scheduled dose, take the missed dose. Otherwise, skip the missed dose and resume the regular schedule.
Adverse Reactions:
- Common Adverse Reactions: Thrombocytopenia, headache, rash, anemia, leukopenia, elevated liver enzymes (ALT/AST).
- Serious Adverse Reactions: Grade ≥3 thrombocytopenia, interstitial lung disease/pneumonitis, venous thromboembolism (including pulmonary embolism), significant liver function abnormalities, and QT interval prolongation.
Contraindications:
- Known hypersensitivity to befotertinib or any component of the formulation.
- Use during pregnancy or breastfeeding is not recommended unless clearly necessary.
Precautions:
- Monitor platelet counts, liver function, and ECG (QT interval) during treatment.
- Monitor for symptoms of interstitial lung disease (new or worsening cough, dyspnea).
- Caution in patients with history of thromboembolic events.
- Dose interruption or reduction may be required for severe toxicity.

Befotertinib Interactions

Metabolized primarily by CYP3A4. Avoid concomitant use with strong CYP3A4 inhibitors or inducers (e.g., ketoconazole, rifampin) whenever possible.
Caution with drugs affecting P-glycoprotein transport or with other agents known to prolong the QT interval.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.