Utidelone Application Scope

Treatment of metastatic (recurrent or advanced) breast cancer, especially in patients previously treated with anthracyclines and taxanes.
Phase III trials underway for non-small cell lung cancer, gastric cancer, breast cancer neoadjuvant therapy, etc.

Characteristics

Ingredients:
- Active ingredient: Utidelone (epothilone D analogue). Produced via microbial fermentation
- Excipients: Not publicly listed (refer to full prescribing information/manufacturer
Properties:
- Epothilone-based microtubule stabilizer distinct from taxanes.
- Overcomes taxane resistance, crosses blood-brain barrier, low hematologic toxicity, tolerable peripheral neuropathy
Packaging Specification: 5 mL vial containing 50 mg Utidelone per vial
Storage: Unknown
Expiry Date: Unknown
Executive Standard: Chinese pharmacopoeia and NMPA GMP standards apply; specific number not publicly found.
Approval Number: Unknown
Date of Revision: Unknown
Manufacturer: Beijing Biostar Pharmaceuticals (Biostar Pharma)

Dosage and Administration:
- Typical regimen: 40 mg/m² IV daily on days 1–5 every 21 days (based on NSCLC trials); breast cancer regimens are similar, often combined with capecitabine
- Infusion administered under medical supervision; pre-treatment lab tests and monitoring recommended
Adverse Reactions:
- Common: peripheral neuropathy (Grade 3 in ~23%), fatigue, diarrhea, nausea, vomiting
- Hematologic: neutropenia, anemia, myelosuppression (mainly Grade 1–2)
- Others: myalgia, arthralgia
Contraindications: Known hypersensitivity to Utidelone or formulation components; severe pre-existing neuropathy or bone marrow suppression implied.
Precautions:
- Monitor blood counts regularly; manage cytopenias with supportive care.
- Use caution in patients with liver or kidney impairment
- Monitor for new or worsening neuropathy.

Drug Interactions: Potential CYP3A4 substrates—use cautiously with strong inhibitors/inducers; may exacerbate hematologic or neurologic toxicity when combined with other myelosuppressive/neurotoxic agents

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.