Description
Indication & Scope
BeiTeLin® Ifupinostat Hydrochloride for Injection treats adult patients with relapsed or refractory diffuse large B-cell lymphoma.
- Mechanism: Selective histone deacetylase inhibitor, regulates epigenetic gene expression of lymphoma cells, induces tumor cell apoptosis and inhibits proliferation.
- Drug class: Epigenetic anti-lymphoma agent, HDAC inhibitor.
- Clinical use: Single-agent salvage therapy for relapsed/refractory diffuse large B-cell lymphoma after two or more prior systemic treatment lines.
| Generic Name | Ifupinostat Hydrochloride for Injection |
| Brand Name | BeiTaLin |
| Ingredient | Ifupinostat Hydrochloride |
| Dosage Form | Injection |
| Package | 20.6mg*1 vial/box |
| Conditions Treated | Relapsed diffuse large B-cell lymphoma, refractory diffuse large B-cell lymphoma in adults |
| Taboos | History of severe allergic reaction to HDAC inhibitors, active severe infection, baseline severe thrombocytopenia |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Refrigerate at 2°C–8°C, protect from light and freeze-thaw cycles |
| Manufacturer | BiBeiTe Pharmaceutical Co., Ltd. |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20250040 |
| Approval Date | Jun 30, 2025 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Fixed intravenous infusion dose, administered once every 3 weeks.
Time: Intravenous drip over 30 minutes on Day 1 of each 21-day cycle.
Instructions for use: Reconstitute and dilute strictly following aseptic operation standards; monitor blood cell counts weekly during treatment.
Interaction: Concurrent use of other myelosuppressive agents will aggravate hematological adverse reactions.
Side effects:
1. Common: thrombocytopenia, anemia, fatigue, nausea, anorexia.
2. Severe: severe neutropenia, tumor lysis syndrome, cardiac arrhythmia.
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 use of Ifupinostat Hydrochloride for Injection?
It is used as single-agent salvage therapy for relapsed or refractory diffuse large B-cell lymphoma in adults.
What is the administration frequency of Ifupinostat Hydrochloride for Injection?
It is administered via intravenous infusion once every 3 weeks.
What drugs will interact with Ifupinostat Hydrochloride for Injection and aggravate side effects?
Concurrent use of other myelosuppressive agents will aggravate hematological adverse reactions.
What is a life-threatening severe side effect of Ifupinostat Hydrochloride for Injection?
It may cause tumor lysis syndrome and cardiac arrhythmia in severe cases.
BeiTeLin® | Ifupinostat Hydrochloride for Injection | Large B-Cell Lymphoma | DengYueRX
INN: Ifupinostat Hydrochloride for Injection
Indications: Large B-cell lymphoma
Dosage Form: Injection
Strength: 20.6mg/vial
