Description
Indication & Scope
Fulzerasib Tablets treats advanced non-small cell lung cancer with KRAS G12C mutation.
- Mechanism: Irreversible selective KRAS G12C inhibitor, covalently binds to mutant KRAS G12C protein pocket, locks the oncogenic protein in inactive GDP-bound state, blocks downstream MAPK signaling and inhibits tumor cell proliferation.
- Drug class: KRAS G12C inhibitor, oral targeted anti-neoplastic agent.
- Clinical use: Monotherapy for adult patients with previously treated advanced KRAS G12C-mutant non-small cell lung cancer.
| Generic Name | Fulzerasib Tablets |
| Brand Name | Dupert |
| Ingredient | Fulzerasib Tablets |
| Dosage Form | Tablets |
| Package | 0.15g*112 tablets/box |
| Conditions Treated | Advanced non-small cell lung cancer harboring KRAS G12C gene mutation |
| Taboos | 1. Hypersensitivity to fulzerasib or tablet excipients
2. Severe pre-existing hepatic dysfunction 3. Pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed, light-proof and dry storage at 15°C to 30°C |
| Manufacturer | XinDa Biotechnology, Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20240035 |
| Approval Date | Aug 20, 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 300 mg orally once daily. Dose reduction allowed for grade 3 or higher adverse reactions.
Time: Taken at a fixed daily time, with or without meals.
Instructions for use:
1. Confirm KRAS G12C mutation positivity via companion diagnostic testing before treatment.
2. Swallow tablets whole with water, do not split or chew.
3. Monitor liver function and gastrointestinal toxicity regularly.
4. Dose interruption or reduction for severe hepatotoxicity or diarrhea.
Interaction:
1. Strong CYP3A4 inhibitors increase plasma concentration and toxicity risk.
2. Strong CYP3A4 inducers significantly reduce therapeutic efficacy.
3. Gastric acid reducing agents (PPIs, H2 blockers) reduce drug absorption.
Side effects:
1. Common: Diarrhea, nausea, vomiting, fatigue, elevated liver transaminases, musculoskeletal pain
2. Severe: Severe hepatotoxicity, interstitial lung disease, severe persistent diarrhea
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indicatiaon, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What gene mutation does Fulzerasib Tablets target?
It treats advanced non-small cell lung cancer with KRAS G12C mutation.
What is Fulzerasib Tablets' mechanism of action?
It irreversibly inhibits mutant KRAS G12C and blocks MAPK tumor signaling.
What are common side effects of Fulzerasib Tablets?
Diarrhea, nausea, vomiting, fatigue, elevated liver enzymes, and muscle pain.
Who cannot take Fulzerasib Tablets?
Patients with severe hepatic dysfunction, drug hypersensitivity, and pregnant or breastfeeding women.
Dupert® | Fulzerasib Tablets | Lung Cancer | DengYueRX
INN: Fulzerasib Tablets
Indications: Lung cancer
Dosage Form: Tablets
Strength: 0.15g/tablet
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
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