Ameile (Aumolertinib Mesylate) – NSCLC | DengYueMed

Ameile Application Scope

Ameile is a third‑generation, irreversible EGFR tyrosine kinase inhibitor used to treat EGFR‑mutated non‑small cell lung cancer (NSCLC).

Characteristics

• Ingredients: Aumolertinib Mesylate

• Properties:

  • Oral, irreversible EGFR‑TKI targeting both common sensitizing mutations (exon 19 del, L858R)

  • Resistance mutation T790M

  • Third‑generation with higher CNS penetration and lower wild‑type EGFR toxicity

• Packaging Specification: 110 mg tablets; typically packaged in bottles or blister packs for daily dosing

• Storage: Store at room temperature in the original container; protect from moisture

• Expiry Date: ​As stated on the package, follow label guidance

• Executive Standard: Meets China NMPA and international pharmaceutical standards (ATC L01EB11)

• Approval Number:

  • NMPA approved in March 2020 (T790 M+)

  • December 2021 (first-line exon19/21), and 2024‑2025 for additional indications

• Date of Revision: Most recent label update: May 9, 2025

• Manufacturer: Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma)

Guidelines for the Use of Ameile

• Dosage and Administration:

  • 110 mg orally once daily

  • Approved as second‑line for EGFR T790M+ NSCLC (≥ March 2020)

  • Approved as first‑line for advanced/metastatic exon 19 del or L858R mutations (≥ Dec 2021)

  • Expanded to adjuvant settings post‑resection (2024) and unresectable Stage III (2025)

• Adverse Reactions:

  • Common AEs: rash, diarrhea, elevated liver enzymes, CPK increase — mostly Grade 1‑2

  • Low rate of interstitial lung disease, QT prolongation, or severe rash

• Contraindications:

  • Hypersensitivity to aumolertinib or ingredients

  • Not for wild‑type EGFR NSCLC

• Precautions:

  • Monitor liver function and ECG periodically

  • Caution in patients with cardiac risk factors

  • Reassess therapy in cases of CNS metastases

Ameile Interactions

• Drug Interactions:

  • Metabolized by CYP3A4; avoid strong inhibitors/inducers

  • Potential interactions with other QT‑prolonging drugs

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
• It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.