Description
Indication & Scope
Treatment of advanced NRAS-mutant melanoma progressing after prior anti-PD-1/PD-L1 immunotherapy.
- Mechanism: Selective MEK1/2 inhibitor; blocks RAS-RAF-MEK-ERK tumor signaling pathway to arrest melanoma cell proliferation and induce cancer cell apoptosis.
- Drug class: Oral small-molecule MEK kinase inhibitor, targeted anti-melanoma chemotherapeutic.
- Clinical use: Second-line targeted monotherapy for NRAS-mutant late-stage melanoma after immunotherapy failure.
| Generic Name | Tunlametinib Capsules |
| Brand Name | KeLuPing |
| Ingredient | Tunlametinib Capsules |
| Dosage Form | Capsules |
| Package | 3mg*56 capsules/box |
| Conditions Treated | Advanced unresectable or metastatic NRAS-mutant melanoma |
| Taboos | 1. Hypersensitivity to tunlametinib or capsule excipients
2. Severe uncontrolled ocular disease (retinal vein occlusion history) 3. Severe left ventricular ejection fraction dysfunction 4. Pregnant women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Sealed storage below 25°C, light-proof and dry environment |
| Manufacturer | KeZhou Pharmaceutical Research and Development Co., Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20240009 |
| Date of Revision | 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 12 mg oral twice daily (every 12 hours).
Time: Morning and evening fixed schedule, consistent 12-hour dosing gap.
Instructions for use:
1. Swallow capsules whole with water; do not open, chew or crush pellets.
2. Confirm NRAS mutation via companion diagnostic test before treatment.
3. Monitor cardiac ejection fraction and eye fundus regularly
4. Skip missed dose if less than 8 hours remain before next scheduled intake.
Interaction:
1. Strong CYP3A4 inhibitors raise systemic exposure and toxicity risk.
2. Strong CYP3A4 inducers reduce plasma concentration and therapeutic efficacy.
3. Concurrent cardiotoxic chemotherapy amplifies left ventricular dysfunction risk.
Side effects:
1. Common: Rash, diarrhea, peripheral edema, fatigue, creatine kinase elevation, dry eye.
2. Severe: Retinal vein occlusion, severe cardiomyopathy, severe interstitial lung disease, grade 4 cutaneous toxicity.
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 patient population is Tunlametinib specifically indicated for?
Adult patients with unresectable or metastatic melanoma harboring NRAS mutations.
What specific molecular target does it inhibit, and how does this affect the MAPK pathway?
It is a selective ERK1/2 inhibitor that blocks downstream signaling in the MAPK pathway, which is constitutively activated in NRAS-mutant melanoma.
What is the typical time to objective response (TTR) in NRAS-mutant advanced melanoma patients treated with Tunlametinib?
Responses are generally observed within 6–8 weeks of treatment initiation, as measured by RECIST criteria.
How does Tunlametinib differ from BRAF inhibitors in treating NRAS-mutant melanoma?
Unlike BRAF inhibitors, it targets ERK downstream in the MAPK pathway, making it effective for NRAS-mutant tumors that are not sensitive to BRAF inhibitors.
KeLuPing® | Tunlametinib Capsules | Late Stage Melanoma with NRAS Mutation | DengYueRX
INN: Tunlametinib Capsules
Indications: Treatment of advanced NRAS-mutant melanoma progressing after prior anti-PD-1/PD-L1 immunotherapy.
Dosage Form: Capsules
Strength: 3mg/capsule
