Description
Indication & Scope
XuanFeiNing® Dirozalkib Tablets treats adult patients with locally advanced or metastatic non-small cell lung cancer confirmed with ALK gene rearrangement, who have not received prior ALK inhibitor treatment.
- Mechanism: Dirozalkib is a selective small-molecule tyrosine kinase inhibitor that covalently binds to the kinase domain of anaplastic lymphoma kinase (ALK). It blocks downstream ALK-mediated cell proliferation signaling pathways, induces tumor cell cycle arrest and apoptosis, and inhibits tumor growth in ALK-rearranged lung cancer lesions.
- Drug class: Antineoplastic agent; ALK tyrosine kinase inhibitor (oral targeted anti-cancer drug).
- Clinical use: First-line monotherapy for unresectable ALK-positive locally advanced or metastatic NSCLC; provides durable disease control and intracranial anti-tumor activity for patients with brain metastases.
| Generic Name | Dirozalkib Tablets |
| Brand Name | XuanFeiNing |
| Ingredient | Dirozalkib |
| Dosage Form | Tablets |
| Package | 50mg* 28tablets/box;
250mg*56 tablets/box |
| Conditions Treated | Locally advanced or metastatic non-small cell lung cancer with confirmed ALK gene fusion/rearrangement |
| Taboos | Patients with severe hypersensitivity to dirozalkib or any excipients in the tablet formulation; pregnant women without controlled tumor indications |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store sealed at 2°C to 30°C, protected from strong light and moisture; keep in original blister packaging. Do not freeze |
| Manufacturer | XuanZhu Biopharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250055; H20250056 |
| Approval Date | Feb 11, 2026 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 300 mg orally once daily for adult patients. Adjust dose to 200 mg or suspend administration upon grade 3 or higher adverse toxicities.
Time: Take at a fixed time every 24 hours, with or without food. If a dose is missed for more than 6 hours, skip the missed dose and resume regular dosing the next day; do not take double doses.
Instructions for use: Swallow tablets whole with plain water; do not crush, split or chew tablets. Standard laboratory monitoring of liver function, blood routine and ECG is required before initiation and every 2 weeks during the first treatment month.
Interaction: Strong CYP3A4 inhibitors (ketoconazole, clarithromycin) increase systemic exposure of dirozalkib, requiring dose reduction; strong CYP3A4 inducers (rifampicin, phenytoin) significantly reduce drug efficacy and should be avoided.
Side effects:
1. Common adverse reactions: elevated liver transaminases, diarrhea, fatigue, visual disturbance, peripheral edema.
2. Severe rare side effects: interstitial lung disease, severe QT interval prolongation, severe neutropenia.
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 is the primary clinical indication of Dirozalkib Tablets?
It is used for adult patients with locally advanced or metastatic non-small cell lung cancer with confirmed ALK gene rearrangement who have no prior ALK inhibitor treatment.
What is the standard recommended daily dose of Dirozalkib Tablets for adults?
The standard dose is 300 mg taken orally once every day.
What are the main contraindications for using Dirozalkib Tablets?
It is prohibited for patients with severe hypersensitivity to Dirozalkib or its tablet excipients, and pregnant women without standardized tumor treatment plans.
What are the common adverse reactions of Dirozalkib Tablets?
Common side effects include elevated liver transaminases, diarrhea, fatigue, visual disturbance and peripheral edema.
XuanFeiNing® | Dirozalkib Tablets | Lung Cancer | DengYueRX
INN: Dirozalkib Tablets
Indications: Non small cell lung cancer(ALK)
Dosage Form: Tablets
Strength: 50mg/tablet; 250mg/tablet
