- Indications and Usage Fulzerasib tablets are indicated for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.
- Dosage and Administration Recommended Dosage: The recommended dosage is 600 mg taken orally twice daily. Administration: Tablets should be swallowed whole and can be taken with or without food. Missed Dose: If a dose is missed by more than 4 hours, do not make up for it. Take the next dose at the regular scheduled time. Dose Modifications: For intolerable adverse reactions, the dose may be reduced to 450 mg twice daily, then to 300 mg once daily.
- Mechanism of Action Fulzerasib is a potent, selective, and reversible covalent inhibitor of the KRAS G12C mutant protein. It works by binding to the switch-II pocket of the mutant KRAS protein, locking it in its inactive GDP-bound state and thereby inhibiting downstream signaling pathways involved in tumor cell proliferation.
- Safety and Warnings Hepatotoxicity: Monitor liver function tests (ALT, AST, bilirubin) before initiation, during the first 3 months, and periodically thereafter. Interstitial Lung Disease/Pneumonitis: Monitor for respiratory symptoms. Permanently discontinue the drug if severe or recurrent non-infectious pneumonitis occurs. Embryo-Fetal Toxicity: Fulzerasib can cause fetal harm. Effective contraception is required during treatment and for at least 1 month after the final dose.
- Adverse Reactions and Clinical Research Common Adverse Reactions: The most common adverse reactions include anemia, increased ALT, increased AST, increased blood bilirubin, proteinuria, fatigue, hypoproteinemia, pruritus, edema, and increased gamma-glutamyltransferase. Clinical Research: Efficacy and safety were established in a single-arm clinical trial involving adult patients with KRAS G12C-mutated NSCLC.
- Drug Interactions CYP2D6 Substrates: Fulzerasib is a moderate inhibitor of CYP2D6. Caution is advised when co-administering with sensitive CYP2D6 substrates. Other CYP Enzymes: In vitro data suggest potential inhibition or induction of CYP2C8 and CYP3A4. Caution is advised when co-administering with substrates of these enzymes.
- Pharmaceutical Information Composition: The active ingredient is fulzerasib. Appearance: The tablets are yellow, round, film-coated tablets, imprinted with “IN” on one side. Storage: Store in a tightly closed container at controlled room temperature and protect from moisture.
Dupert Fulzerasib Tablets
Brand Name: 达伯特 ®（Dupert®）
Generic Name: Fulzerasib
Strength: 0.15 g per tablet, 112 tablets per bottle
Manufacturer: Contron Chemistry (Ningbo) Technology Development Co., Ltd.
Marketing Authorization Holder: Innovent Biologics (Suzhou) Co., Ltd. / GenFleet Therapeutics
Approval Date in China: August 21, 2024
Registration Number: 国药准字H20240035
Storage: Keep tightly sealed, store at temperature not exceeding 30°C, preserve in the original package, protect from light and moisture. Keep out of reach of children. Refer to the full package insert for detailed storage specifications.
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