- Indications and Usage Furmonertinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after EGFR-TKI therapy and have confirmed EGFR T790M mutation-positive disease.
- Dosage and Administration Recommended Dosage: The recommended dosage is 80 mg orally once daily until disease progression or intolerable toxicity. Administration: The tablets should be administered on an empty stomach. Swallow the tablet whole with water; do not chew or crush. Missed Dose: If a dose is missed and the delay is more than 12 hours, take the missed dose. If the delay is less than 12 hours, skip the missed dose and take the next dose at the scheduled time. Dose Modification: If dose reduction is required due to adverse reactions, the dose should be reduced to 40 mg once daily.
- Mechanism of Action Furmonertinib is a third-generation irreversibly binding epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It inhibits EGFR sensitizing mutations (such as Exon 19 deletion and L858R) and the resistant T790M mutant, thereby blocking downstream signaling pathways and inhibiting tumor cell growth.
- Safety and Warnings Hepatotoxicity: Transaminase elevations are common. Monitor liver function regularly. Dose interruption, reduction, or discontinuation may be necessary for ≥Grade 3 elevations. QTc Prolongation: Monitor ECG, especially in patients with risk factors for arrhythmia. Suspend treatment if QTc interval >500 ms. Interstitial Lung Disease: Monitor for respiratory symptoms. Permanent discontinuation is required for any grade of interstitial lung disease. Cardiomyopathy: Monitor for signs of heart failure. Dose interruption or discontinuation may be necessary.
- Adverse Reactions and Clinical Research The most common adverse reactions include elevated liver enzymes, QTc interval prolongation, rash, diarrhea, fatigue, and elevated creatinine. Serious adverse reactions may include interstitial lung disease, cardiomyopathy, and febrile neutropenia.
- Drug Interactions CYP3A4 Inhibitors: Strong CYP3A4 inhibitors may increase plasma concentrations of furmonertinib. CYP3A4 Inducers: Strong CYP3A4 inducers may decrease plasma concentrations of furmonertinib. QTc-Prolonging Drugs: Concomitant use may increase the risk of QTc interval prolongation.
- Pharmaceutical Information Composition: The active ingredient is Furmonertinib. Excipients include lactose monohydrate, microcrystalline cellulose, povidone, croscarmellose sodium, and magnesium stearate. Appearance: Yellow film-coated tablets. Storage: Store at controlled room temperature in the original packaging.
Aifusha Furmonertinib Mesilate Tablets
Brand Name: 艾弗沙 ®（Aifusha®）
Generic Name: Furmonertinib Mesilate
Strength: 40 mg per tablet, 28 tablets per box
Manufacturer: Jiangsu Allist Biomedicine Co., Ltd.
Marketing Authorization Holder: Shanghai Allist Pharmaceutical Technology Co., Ltd.
Approval Date in China: March 3, 2021
Registration Number:国药准字 H20210008
Storage: Store tightly sealed, protected from light at temperature below 25°C. Refer to the full package insert for detailed storage specifications.
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