Youtidi Utidelone Injection

1. Indications and Usage
Head and Neck Cancer: Treatment of patients with recurrent or metastatic head and neck cancer who have failed platinum-based chemotherapy.
Non-Small Cell Lung Cancer (NSCLC): Treatment of patients with locally advanced or metastatic NSCLC who have failed prior chemotherapy.
Pancreatic Cancer: Treatment of patients with metastatic pancreatic adenocarcinoma who have failed first-line gemcitabine-based therapy.
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Infusion ONLY.
Recommended Dosage: 150 mg/m² or 200 mg/m² administered once every 21 days.
Critical Administration Instructions:
Preparation: Dilute the required dose in 0.9% Sodium Chloride or 5% Dextrose to a final concentration between 0.5 mg/mL and 2.0 mg/mL.
Infusion Time: Administer via IV infusion over 1 to 2 hours.
Pre-medication: Pre-medication with corticosteroids is required to prevent hypersensitivity reactions.
3. Mechanism of Action
Microtubule Modulation: Utidelone binds with high affinity to the beta-tubulin subunit of microtubules.
Cell Cycle Arrest: It promotes the formation of abnormal microtubule bundles, disrupting normal microtubule dynamic instability and arresting cells in the G2/M phase.
Apoptosis: This disruption leads to the inhibition of tumor cell proliferation and induction of apoptosis.
4. Safety and Warnings
Hypersensitivity Reactions: Severe allergic reactions may occur; pre-medication with corticosteroids is mandatory.
Myelosuppression: Neutropenia, leukopenia, and febrile neutropenia are common and require regular monitoring of blood counts.
Neuropathy: Peripheral neuropathy may develop and can be irreversible in some cases.
Hepatotoxicity: Elevations in liver enzymes (AST, ALT, and bilirubin) have been observed.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Neutropenia, leukopenia, peripheral neuropathy, fatigue, nausea, vomiting, and febrile neutropenia.
Clinical Research Highlights: Phase 3 clinical trials demonstrated that Utidelone significantly improved objective response rates and clinical benefit rates compared to standard chemotherapy in head and neck cancer and NSCLC patients who had progressed on prior regimens.
6. Drug Interactions
CYP3A4 Inhibitors/Inducers: Concomitant use with strong CYP3A4 inhibitors or inducers may alter the pharmacokinetics of Utidelone.
Hepatotoxic Drugs: Caution is advised when used with other drugs known to cause liver injury.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Utidelone. Excipients: Polysorbate 80, Ethanol, Water for Injection.
Appearance: The concentrate for solution for infusion is a clear, colorless to slightly yellow liquid.
Packaging: Single-use vial (3 mg/mL).
Storage: Store at 2°C to 8°C. Do not freeze.