Description
Indication & Scope
XuanYueNing® Bireociclib Tablets treats HR-positive, HER2-negative advanced or metastatic breast cancer, used in combination with fulvestrant for patients progressing after prior endocrine therapy.
- Mechanism: Selective dual CDK4/6/2 inhibitor that blocks retinoblastoma (Rb) protein phosphorylation, arrests tumor cell cycle at G1 phase and inhibits proliferation of hormone receptor positive breast cancer cells.
- Drug class: Oral cyclin-dependent kinase (CDK4/6) inhibitor, targeted anti-tumor prescription small-molecule medicine.
- Clinical use: Second-line combination therapy for endocrine therapy resistant advanced metastatic breast cancer.
| Generic Name | Bireociclib Tablets |
| Brand Name | XuanYueNing |
| Ingredient | Bireociclib Tablets |
| Dosage Form | Tablets |
| Package | 120mg*56 tablets/box |
| Conditions Treated | HR-positive, HER2-negative advanced and metastatic breast cancer |
| Taboos | Severe hypersensitivity to bireociclib; patients with severe neutropenia or active severe infections; pregnant women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store at temperature below 25°C, sealed, light-proof and moisture-proof |
| Manufacturer | XuanZhu Biotchnology Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250013 |
| Approval Date | Jul 15, 2025 |
| Shelf Life | 36 months |
How to use ?
Recommended Dose: Fixed daily oral dose taken continuously until disease progression or intolerable hematological toxicity occurs.
Time: Same daily dosing time, taken throughout each 28-day endocrine therapy cycle.
Instructions for use: Swallow tablets whole, can be taken with or without meals; regular complete blood count monitoring is required for neutropenia management.
Interaction: Strong CYP3A4 inhibitors increase drug exposure and hematological toxicity risk, strong CYP3A4 inducers reduce efficacy, concurrent use is not recommended.
Side effects: Neutropenia, leukopenia, diarrhea, fatigue, nausea, elevated liver transaminases and alopecia.
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 clinical indication of Bireociclib Tablets?
It is used for HR-positive, HER2-negative advanced breast cancer with endocrine therapy resistance.
What drug class does Bireociclib Tablets belong to?
It is a selective oral CDK4/6/2 targeted anti-tumor inhibitor.
How does Bireociclib Tablets inhibit tumor growth?
It blocks tumor cell cycle progression at G1 phase and inhibits abnormal breast cancer cell proliferation.
What drugs interact significantly with Bireociclib Tablets?
Strong CYP3A4 regulators will change drug exposure and should be avoided during treatment.
XuanYueNing® | Bireociclib Tablets | Breast Cancer | DengYueRX
INN: Bireociclib Tablets
Indications: Breast cancer
Dosage Form: Tablets
Strength: 120mg/tablet
Low MOQ
WHO-GMP
Worldwide Delivery
Compliance and Regulatory Documents
Related Products
