Description
Indication & Scope
FuMaiNing® Luvometinib Tablets provides the treatment of adult patients with Langerhans cell histiocytosis (LCH) and histiocytic tumors; treatment of symptomatic, inoperable plexiform neurofibromas in children and adolescents aged ≥2 years with Neurofibromatosis Type 1 (NF1).
- Mechanism: Selective oral MEK1/2 inhibitor, blocks abnormal RAS-MEK-ERK hyperactive signaling pathway driven by NF1 gene mutation and histiocytic proliferative gene alterations, suppresses abnormal histiocyte and neurofibroma cell proliferation.
- Drug class: Oral MEK kinase inhibitor, rare tumor targeted prescription small-molecule medicine.
- Clinical use: Long-term targeted control for progressive LCH and inoperable NF1-related plexiform neurofibromas in pediatric and adult patients.
| Generic Name | Luvometinib Tablets |
| Brand Name | FuMaiNing |
| Ingredient | Luvometinib |
| Dosage Form | Tablets |
| Package | 1mg*30 tablets/box;
4mg*30 tablets/box |
| Conditions Treated | Langerhans cell histiocytosis in adults; symptomatic inoperable plexiform neurofibromas in NF1 patients aged 2 years and above |
| Taboos | Severe hypersensitivity to luvometinib; patients with severe ocular retinal lesions; pregnant women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store sealed at 20°C–25°C, protected from direct sunlight and moisture |
| Manufacturer | Fosun Pharmaceutical Industry Development Co., Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250025; H20250026 |
| Approval Date | May 27, 2025 |
| Shelf Life | 30 months |
How to use ?
Recommended Dose: Age and weight-adjusted twice-daily oral dose for continuous long-term treatment.
Time: Dosed 12 hours apart daily throughout repeated treatment cycles.
Instructions for use: Swallow tablets whole, can be taken with meals; regular ophthalmic examination every 3 months to monitor retinal toxicity risk.
Interaction: Strong CYP3A4 inhibitors and inducers require dose modification; avoid concurrent use with other MEK inhibitors.
Side effects: Acneiform rash, diarrhea, peripheral edema, ocular blurred vision, fatigue, elevated creatine kinase.
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 are the two major indications of Luvometinib Tablets?
It treats adult Langerhans cell histiocytosis and inoperable plexiform neurofibromas in NF1 children over 2 years old.
What is the mechanism of Luvometinib Tablets?
It is a MEK1/2 inhibitor that blocks the abnormal RAS-MEK-ERK proliferation signaling pathway.
What special organ toxicity needs close observation when suing Luvometinib Tablets?
Retinal and ocular adverse reactions require regular ophthalmic examination every 3 months.
What are the common side effects of Luvometinib Tablets?
Acne-like rash, diarrhea, peripheral edema and elevated creatine kinase are typical reactions.
FuMaiNing® | Luvometinib Tablets | LCH/PN/NF1 | DengYueRX
INN: Luvometinib Tablets
Indications: LCH/PN/NF1
Dosage Form: Tablets
Strength: 1mg/tablet; 4mg/tablet
