Ruibida Rezivertinib Mesylate Capsules

1. Indications and Usage
Rezivertinib is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR T790M mutation positive disease who have progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
2. Dosage and Administration
Standard Dosage: The recommended dose is 180 mg orally once daily.
Administration: It can be taken with or without food. The capsule should be swallowed whole with water and should not be chewed, crushed, or opened.
Missed Dose: If a dose is missed and the delay is less than 12 hours, take it immediately. If the delay exceeds 12 hours, skip the dose and take the next one at the regular time.
Dose Modification: If dose reduction is required based on safety and tolerance, the dose should be reduced to 120 mg once daily.
3. Mechanism of Action
Rezivertinib is an irreversible, high-selectivity third-generation small molecule EGFR-TKI. It inhibits the activity of EGFR T790M mutations, thereby overcoming drug resistance during EGFR-TKI therapy.
4. Safety and Warnings
Severe Toxicities: Monitor for interstitial lung disease (ILD), myocardial dysfunction, QTc interval prolongation, and hepatotoxicity.
Hematologic Toxicity: Monitor for leukopenia, thrombocytopenia, and anemia.
Renal and Hepatic Impairment: Dose adjustment is required for mild hepatic or mild-to-moderate renal impairment. Use with caution in moderate-to-severe hepatic or severe/terminal renal impairment.
5. Adverse Reactions and Clinical Research
The most common adverse reactions are leukopenia, thrombocytopenia, anemia, and rash. Other reported reactions include hypertension, proteinuria, hand-foot skin reaction, fatigue, and hypothyroidism.
6. Drug Interactions
CYP3A4 Inhibitors: Rezivertinib can be used in combination with CYP3A4 inhibitors.
CYP3A4 Inducers: Avoid using Rezivertinib in combination with strong CYP3A4 enzyme inducers.
7. Pharmaceutical Information
Composition: The active ingredient is Rezivertinib Mesylate.
Appearance: It is available as capsules.
Storage: Store in the original carton at controlled room temperature.