Furmonertinib - Package Insert

Update: 30 Jan,2026 Source: Haiou Health Views: 136

Furmonertinib is an oral targeted therapeutic agent indicated for epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), and belongs to the third-generation EGFR tyrosine kinase inhibitors (TKIs). It is indicated for the treatment of patients with locally advanced or metastatic NSCLC who have experienced disease progression following prior EGFR-TKI therapy and have a confirmed EGFR T790M mutation. The medication may be administered on an empty stomach or with food, and the specific dosage should be adjusted according to the physician’s instructions.

Indications and Administration

Indications

For the second-line or subsequent-line treatment of locally advanced or metastatic NSCLC with confirmed EGFR T790M mutation positivity.

Dosage and Administration

The recommended dosage is 80 mg orally, administered once daily.

If a dose is missed, no supplemental dose should be taken; the next dose should be taken at the scheduled time.

Adverse Reactions

Common Reactions (Incidence ≥ 10%)

Rash, diarrhea, oral ulceration, decreased appetite, elevated transaminase levels, etc. These reactions are generally mild to moderate in severity.

Serious Reactions

Medical attention should be sought immediately if the following conditions occur: interstitial lung disease (manifesting as dyspnea, fever), QT interval prolongation (manifesting as palpitations, syncope), myocardial injury (manifesting as chest pain, fatigue), and other related severe symptoms.

Precautions

Contraindications

Contraindicated in patients with hypersensitivity to any ingredient of this product.

Concomitant use with other medications that prolong the QT interval should be avoided during treatment.

Special Populations

Pregnant women, lactating women, and patients with hepatic or renal impairment require a rigorous risk assessment before use.

The safety and efficacy of this medication in pediatric patients have not been established.

Monitoring Requirements

During treatment, regular monitoring is recommended, including liver function tests, electrocardiography (ECG), electrolyte levels (particularly serum potassium and serum magnesium), and thoracic imaging examinations.

Drug Interactions

Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine) may reduce the plasma concentration of furmonertinib. Concomitant use should be avoided or dosage adjustment should be implemented under medical supervision.

Gastric acid regulators (e.g., omeprazole) may affect the absorption of furmonertinib. It is recommended that administration be separated by an interval of at least 2 hours.

Storage and Shelf Life

Storage Conditions

Store in a light-resistant, sealed container at a temperature below 30°C. Keep out of the reach of children.

Shelf Life

Use within the validity period printed on the packaging. Do not use after the expiration date.

Important Notice

Furmonertinib is a prescription drug. Prior to use, genetic testing must be performed to confirm the presence of the EGFR T790M mutation, and the medication must be used strictly under the guidance of a qualified physician.

If severe discomfort or suspected drug resistance (e.g., worsening symptoms, new lesion formation) occurs during treatment, prompt medical follow-up is required to adjust the therapeutic regimen.

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