Ameluo Almonertinib Mesylate Tablets

1. Indications and Usage
Third-line Treatment: For 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.
First-line Treatment: For adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 (L858R) substitution mutations.
2. Dosage and Administration
Recommended Dosage: The standard dosage is 110 mg orally once daily until disease progression or intolerable toxicity.
Administration: The tablet can be taken with or without food. Swallow whole with water; do not chew or crush.
Missed Dose: If the delay is more than 12 hours, take the missed dose. If less than 12 hours, skip the missed dose.
Dose Modification: If dose reduction is required due to adverse reactions, the dose should be reduced to 55 mg once daily.
3. Mechanism of Action
Almonertinib is a third-generation irreversibly binding epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It inhibits both sensitizing EGFR mutations (such as Exon 19 deletion and L858R) and the resistant T790M mutation, thereby blocking downstream signaling pathways and inhibiting tumor cell growth.
4. Safety and Warnings
Interstitial Lung Disease: Monitor for respiratory symptoms. Permanent discontinuation is required for interstitial lung disease.
Hepatotoxicity: Monitor liver function regularly. Dose interruption, reduction, or discontinuation may be necessary for severe elevations.
QTc Prolongation: Monitor ECG, especially in patients with risk factors for arrhythmia. Suspend treatment if the QTc interval exceeds 500 ms.
Cardiomyopathy: Monitor for signs of heart failure. Dose interruption or discontinuation may be necessary.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: The most common adverse reactions include rash, elevated serum creatine kinase, pruritus, and fatigue. Diarrhea occurs at a relatively low frequency.
Clinical Research: Clinical trials have demonstrated significant efficacy in both first-line and third-line settings for EGFR-mutant NSCLC.
6. Drug Interactions
CYP3A4 Inhibitors/Inducers: Avoid concomitant use with strong CYP3A4 inhibitors or inducers.
High-risk Comedications: Use caution when co-administering with drugs that may increase serum creatine kinase (e.g., statins).
7. Pharmaceutical Information
Composition: The active ingredient is Almonertinib.
Appearance: Yellow film-coated tablets.
Storage: Store at controlled room temperature in the original packaging.