Description
Indication & Scope
LuKeDa, an orally active small-molecule Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
- Mechanism: Rocbrutinib selectively inhibits Bruton’s tyrosine kinase (BTK), blocking B-cell receptor signaling pathways involved in the proliferation, survival, and migration of malignant B cells.
- Drug class: Bruton’s tyrosine kinase (BTK) inhibitor.
- Clinical use: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
| Generic Name | Rocbrutinib |
| Brand Name | LuKeDa® |
| Ingredient | Each tablet contains 25 mg or 100 mg rocbrutinib. |
| Dosage Form | Film-coated Tablet. |
| Package | 30 tablets/bottle. |
| Conditions Treated | Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). |
| Taboos | Hypersensitivity to silevimig or any component of the product. |
| Place of origin | China |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Refer to the approved package labeling. |
| Manufacturer | Guangzhou Lupeng Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | LP-168 |
| Date of Revision | 2026 |
| Shelf Life | Refer to the approved package labeling
|
How to use ?
Recommended Dose: 150 mg orally once daily (one 100 mg tablet plus two 25 mg tablets).
Time: Administer at approximately the same time each day according to the approved dosing regimen.
Instructions for use: Administer orally with or without food according to the approved prescribing information. Swallow tablets whole.
Interaction: Rocbrutinib is metabolized mainly by CYP3A enzymes. Concomitant use with CYP3A inhibitors or inducers may affect rocbrutinib exposure. Refer to the approved prescribing information for specific recommendations.
Side effects: Common adverse reactions include decreased neutrophil count, decreased white blood cell count, infections, anemia, thrombocytopenia, rash, and other adverse reactions reported with BTK inhibitors.
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, indication, 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 is BTK and why is it a therapeutic target?
BTK is a key enzyme in the B-cell receptor signaling pathway. Inhibition of BTK can reduce signaling involved in the growth and survival of malignant B cells.
How does Rocbrutinib work in mantle cell lymphoma?
Rocbrutinib inhibits BTK activity, which may interfere with signaling pathways that support the proliferation and survival of lymphoma cells.
What should patients tell their healthcare provider before taking Rocbrutinib?
Patients should inform healthcare providers about their medical history, current medications, and any history of bleeding, infection, or other relevant conditions.
Is LuKeDa® an oral medication?
Yes. LuKeDa is administered orally in tablet form.
LuKeDa® Rocbrutinib | Relapsed or Refractory Mantle Cell Lymphoma | DengYueRX
INN: Rocbrutinib
Indications: Treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
Dosage Form: Film-coated Tablet
Strength: 25 mg/tablet; 100 mg/tablet
