Endostar Recombinant Human Endostatin Injection

1. Indications and Usage
Non-Small Cell Lung Cancer (NSCLC): Used in combination with the NP chemotherapy regimen (vinorelbine and cisplatin) for the treatment of naive or recurrent Stage III/IV non-small cell lung cancer patients.
2. Dosage and Administration
Route of Administration: For Intravenous (IV) Infusion ONLY.
Recommended Dosage: 7.5 mg/m² (1.2 × 10⁵ U/m²) administered once daily.
Critical Administration Instructions:
Preparation: Dilute the required volume in 250-500 mL of 0.9% Sodium Chloride Injection.
Infusion Time: Administer via constant-rate intravenous dripping over 3 to 4 hours.
Cycle Schedule: When combined with the NP regimen, administer daily for 14 consecutive days, followed by a 1-week rest period. This constitutes one treatment cycle, typically repeated for 2 to 4 cycles.
3. Mechanism of Action
Angiogenesis Inhibition: Endostatin is a truncated fragment of collagen XVIII.
Endothelial Cell Migration: It specifically inhibits the migration and proliferation of endothelial cells that form new blood vessels.
Tumor Growth Suppression: By blocking the formation of tumor neovasculature, it cuts off the nutrient supply to tumor cells, thereby inhibiting tumor proliferation and metastasis.
4. Safety and Warnings
Cardiac Disorders: Cardiac adverse reactions (e.g., myocardial ischemia, sinus tachycardia, ST-T changes) are the most common. Regular electrocardiogram (ECG) monitoring during treatment is mandatory.
Contraindications and Precautions: Use with caution in patients with severe cardiac history (e.g., uncontrolled arrhythmias, history of myocardial infarction, heart failure) or renal impairment.
Hypersensitivity: Use with caution in patients with a history of hypersensitivity to protein-based biological products.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Cardiac adverse reactions (chest tightness, palpitations, mild ST-T changes), digestive system reactions (nausea, diarrhea, reversible elevation of liver enzymes), and mild allergic skin rashes.
Clinical Research Highlights: Phase I-III clinical trials demonstrated that the combination of recombinant human endostatin with the NP regimen improved tumor control and clinical outcomes in patients with advanced NSCLC compared to chemotherapy alone.
6. Drug Interactions
Chemotherapy Agents: No systematic studies on drug interactions have been conducted. It is commonly used with vinorelbine and cisplatin.
Administration Precautions: Caution is advised to avoid mixing with other drugs or solutions that may alter the pH and stability of endostatin.
7. Pharmaceutical Information
Chemical Composition: Active Ingredient: Recombinant Human Endostatin (produced in E. coli). Excipients: Sodium acetate, glacial acetic acid, mannitol.
Appearance: Colorless and clear liquid.
Packaging: Single-use vial (15 mg/3 mL).
Storage: Store at 2°C to 8°C, protected from light. Do not freeze.