Firmonertinib Mesilate Tablets – NSCLC | HongKong DengYue Medicine

Ivesa® Firmonertinib Mesilate Tablets Application Scope

Treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR T790M and other sensitizing mutations.

Third-generation, irreversible, mutant-selective EGFR tyrosine kinase inhibitor with high CNS penetration.

Ivesa® Firmonertinib Mesilate Characteristics

• Ingredients:

  • Active: Firmonertinib Mesilate (Furmonertinib Mesylate)

  • Excipients: as per local formulation

  Properties:

  • Oral EGFR TKI targeting EGFR-sensitive mutations (exon 19 del, L858R), resistance T790M, exon 20 insertions, and PACC mutations; able to cross blood–brain barrier.

  Packaging Specification:

  • Tablets: typically 40 mg each (e.g., formulations for 160 mg daily dose require four tablets).

  Storage:

  • Store at room temperature, protected from moisture and light (refer to label).

  Expiry Date:

  • See outer packaging.

  Executive Standard:

  • Meets national regulatory standards per approval region (e.g., China NMPA).

  Approval Number:

  • China (NMPA): First approval in March 2021 for EGFR T790M-positive NSCLC.

  Date of Revision:

  • Jun 23, 2025 (latest data update as per AdisInsight).

  Manufacturer:

  • Allist Pharmaceuticals (China), licensed to ArriVent Biopharma for global (ex‑China) markets.

Guidelines for the Use of Ivesa® Firmonertinib Mesilate Tablets

Dosage and Administration:

• Recommended dose: 160–240 mg orally once daily (e.g., 4 × 40 mg tablets).

• Administration: With or without food.

• Missed Dose: If missed, take as soon as possible; do not double dose; resume next dose at scheduled time.

Adverse Reactions:

Diarrhea, rash/dry skin, stomatitis, elevated liver enzymes; anemia.

Common Adverse Reactions (≥5%):

Diarrhea, rash/dry skin, stomatitis, elevated liver enzymes; anemia.

Serious Adverse Reactions:

• Grade ≥3 events: diarrhea, anemia, elevated AST/ALT levels; no treatment-related deaths reported in trials.

Precautions:

• Monitor liver function regularly.

• Watch for skin reactions and diarrhea; adjust dose if severe.
• Use contraception during treatment and for at least 3 months post-treatment.

Ivesa® Firmonertinib Mesilate Tablets Interactions

• Substrate and inducer of CYP3A4—concomitant use with strong CYP3A modulators requires caution or dose adjustments.

 

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.