Taixinsheng Nimotuzumab Injection

1. Indications and Usage
Nasopharyngeal Carcinoma: In combination with radiotherapy, indicated for the treatment of Stage III or IV nasopharyngeal carcinoma with epithelial growth factor receptor (EGFR) positive expression.
Pancreatic Cancer: In combination with gemcitabine, indicated for the treatment of locally advanced or metastatic pancreatic cancer in patients with wild-type K-Ras.
Head and Neck Squamous Cell Carcinoma: In combination with concurrent chemoradiotherapy, indicated for the treatment of locally advanced head and neck squamous cell carcinoma.
2. Dosage and Administration
Recommended Dosage: 100 mg per administration (for nasopharyngeal carcinoma).
Administration Details: The vial content should be diluted in 250 mL of 0.9% sodium chloride injection. Administer via intravenous infusion over more than 60 minutes.
Treatment Schedule: The first dose should be administered on day 1 of radiotherapy, prior to the start of radiation. Subsequent doses are administered once weekly for a total of 8 weeks.
Preparation: Do not shake. Use immediately after dilution or store at 2°C to 8°C for no more than 12 hours. Cannot be frozen.
3. Mechanism of Action
EGFR Binding: Nimotuzumab binds specifically to the extracellular domain of the epidermal growth factor receptor (EGFR).
Signal Transduction Blockade: It competitively blocks the binding of ligands (such as EGF and TGF-α), thereby inhibiting downstream signaling pathways that drive tumor cell proliferation and angiogenesis.
Cellular Cytotoxicity: It may induce tumor cell apoptosis through antibody-dependent cellular cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC).
4. Safety and Warnings
Hypersensitivity: Severe allergic reactions, including anaphylaxis, may occur. Appropriate resuscitation equipment must be immediately available during administration.
Hepatotoxicity: Elevations in liver enzymes (ALT, AST) and bilirubin may occur. Liver function should be monitored periodically.
Embryo-Fetal Toxicity: Can cause fetal harm. Effective contraception is required during treatment and for 60 days after the final dose.
Infusion-Related Reactions: Monitor closely during and for 1 hour after the infusion.
5. Adverse Reactions and Clinical Research
Most Common Adverse Reactions: Mild fever, nausea, blood pressure fluctuations, fatigue, and rash.
Hematologic Toxicity: Mild leukopenia and neutropenia, often associated with concurrent chemotherapy.
Clinical Research Highlights: Clinical trials in nasopharyngeal carcinoma demonstrated that nimotuzumab combined with radiotherapy significantly improved overall survival and local control rates compared to radiotherapy alone.
6. Drug Interactions
Chemotherapy Agents: When used with chemotherapy, interactions are generally managed according to standard guidelines, but cumulative toxicity should be monitored.
Radiotherapy: Synergistic therapeutic effect is expected when combined with radiotherapy.
Live Vaccines: Avoid live vaccines during treatment due to immunosuppression.
7. Pharmaceutical Information
Chemical Composition: Active ingredient: Nimotuzumab (recombinant DNA-derived humanized monoclonal antibody).
Appearance: Colorless and clear liquid.
Packaging: Supplied in single-use glass vials (50 mg/10 mL).
Storage: Store in a refrigerator at 2°C to 8°C. Do not freeze. Protect from light.