Description
Indication & Scope
Treatment of locally advanced or metastatic prostate cancer.
- Mechanism: Selective class I histone deacetylase (HDAC) inhibitor. It inhibits histone deacetylation to remodel chromatin, upregulate tumor suppressor gene expression, suppress prostate cancer cell proliferation, induce tumor cell apoptosis and reverse endocrine therapy resistance.
- Drug class: Histone Deacetylase (HDAC) inhibitor, oral targeted antineoplastic agent.
- Clinical use: Single-agent or combined endocrine therapy for progressive locally advanced/metastatic prostate cancer after prior standard treatment failure.
| Generic Name | Entinostat Tablets |
| Brand Name | JingZhuDa |
| Ingredient | Entinostat Tablets |
| Dosage Form | Tablets |
| Package | 5mg*4 tablets/box |
| Conditions Treated | Locally advanced or metastatic prostate cancer |
| Taboos | 1. Severe hypersensitivity to entinostat or any tablet excipients
2. Severe myelosuppression at baseline 3. Severe hepatic or renal function failure 4. Pregnant and breastfeeding women |
| Place of origin | China |
| Prescription type | Prescription-only |
| Storage Conditions | Store in sealed, light-proof packaging at 2°C~25°C, avoid high humidity and direct sunlight. |
| Manufacturer | YiTengJingAng Pharmaceutical Co., Ltd |
| Registration Authority | National Medical Products Administration (NMPA), China |
| Approval number | H20240013 |
| Date of Revision | 2024 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: Standard dose: 5 mg orally once weekly. Dose reduction to 3 mg weekly is allowed for grade 3/4 adverse reactions.
Time: Take on an empty stomach at a fixed time once every 7 days.
Instructions for use:
1. Swallow tablets whole with plain water; do not crush, split or chew.
2. Monitor complete blood count, liver and renal function regularly throughout treatment.
3. Dose suspension or reduction is required for severe hematologic toxicity.
4. Avoid live vaccines during treatment.
Interaction:
1. Strong CYP3A4 inhibitors increase entinostat plasma concentration and toxicity risk.
2. Strong CYP3A4 inducers reduce therapeutic efficacy.
3. Concomitant myelosuppressive chemotherapy increases neutropenia and thrombocytopenia risk.
Side effects:
1. Common: Fatigue, nausea, diarrhea, neutropenia, thrombocytopenia, elevated liver enzymes, anorexia
2. Severe: Severe bone marrow suppression, interstitial lung disease, severe hepatic injury, allergic anaphylaxis
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 mechanism of action of Entinostat?
It is a selective class I histone deacetylase (HDAC) inhibitor that promotes histone hyperacetylation, reactivating tumor suppressor genes and inducing cancer cell cycle arrest and apoptosis.
What is the approved indication for Entinostat?
It is indicated for locally advanced or metastatic breast cancer, typically used in combination with endocrine therapy for hormone receptor-positive disease.
What is the typical dosing frequency of Entinostat?
It is administered orally once weekly, which helps manage potential adverse effects.
How does Entinostat’s isoform selectivity affect its safety profile compared to non-selective HDAC inhibitors?
Its selectivity for class I HDACs is associated with a better tolerability profile, reducing the risk of severe toxicities like thrombocytopenia seen with pan-HDAC inhibitors.
JingZhuDa® | Entinostat Tablets | Locally Advanced or Metastatic Breast Cancer | DengYueRX
INN: Entinostat Tablets
Indications: Treatment of locally advanced or metastatic prostate cancer.
Dosage Form: Tablets
Strength: 5mg/tablet
