Nimotuzumab Application Scope

Nimotuzumab is a recombinant humanized monoclonal antibody therapeutic. Its primary application is in the treatment of various solid tumors that overexpress the Epidermal Growth Factor Receptor (EGFR).

Nimotuzumab Characteristics

Ingredients: Nimotuzumab
Properties: A clear, colorless to slightly yellow liquid for intravenous infusion
Packaging Specification: Typically 10 mL vial containing 50 mg of Nimotuzumab
Storage: Store at 2°C to 8°C (36°F to 46°F)
Expiry Date: As stated on the packaging
Executive Standard: Complies with the relevant biopharmaceutical manufacturing and quality control standards of the approving health authority
Approval Number: Varies by region and manufacturer
Date of Revision: Product leaflet / SPC revision date is market-specific.
Manufacturer: Biotech Pharmaceutical Co., Ltd.

Guidelines for the Use of Nimotuzumab

Dosage and Administration:
- Recommended Dose:
  - Advanced head & neck tumors: 200 mg IV once weekly for 6 weeks concurrent with radiotherapy/chemo-radiotherapy; thereafter 200 mg every 15 days as maintenance while tolerated.
  - Glioblastoma / high-grade glioma (adults): 200 mg IV once weekly for 6 weeks concurrent with radiotherapy, then 200 mg every 15 days maintenance. Pediatric dosing (e.g., 150 mg/m² weekly induction, then q15d maintenance) for certain pediatric high-grade astrocytomas has been described.
  - Pancreatic adenocarcinoma (locally advanced/metastatic) (example trial/label use): regimens including 400 mg weekly in combination with chemotherapy have been reported in some studies/registrations—follow local approved regimen.
- Administration: Reconstitute and dilute according to product leaflet. Infuse IV over recommended period (commonly 30–60 minutes); monitor vital signs during infusion. No preservative—use prepared infusion immediately or follow the stability instructions on the local SPC.
- Missed Dose: Follow local prescribing guidance. If a scheduled dose is missed, consult the treating physician and local SPC for recommended catch-up regimen.
Adverse Reactions:
- Common Adverse Reactions: Fever, chills, nausea, vomiting, dizziness, mild to moderate rash, transient elevation of liver transaminases (AST, ALT), and blood pressure fluctuations. These are generally manageable.
- Serious Adverse Reactions: Severe infusion reactions (rare), severe allergic reactions (anaphylaxis—very rare). Compared to other anti-EGFR antibodies, nimotuzumab has a significantly lower incidence of severe (grade 3/4) skin rash.
Contraindications:
- Known hypersensitivity to nimotuzumab or any of its components.
- Use during pregnancy is contraindicated unless absolutely necessary. Effective contraception is required during and for several months after treatment.
Precautions:
- Patients should be closely monitored during the infusion for any signs of hypersensitivity or infusion reactions.
- EGFR testing on tumor tissue is recommended prior to treatment to identify patients most likely to benefit.
- Use with caution in patients with pre-existing cardiac or pulmonary conditions.
- Women of childbearing potential and men should use effective contraception during treatment.

Nimotuzumab Interactions

Synergistic Interactions: Nimotuzumab is designed to be used in combination with radiotherapy and/or chemotherapy (e.g., cisplatin, gemcitabine). It acts as a radiosensitizer and chemosensitizer, enhancing the tumor-killing effects of these modalities.
Drug-Drug Interactions: No formal pharmacokinetic drug-drug interaction studies have been conducted. However, as it is a large monoclonal antibody, interactions with small molecule drugs are unlikely. Caution should be exercised when administered with other drugs that can cause similar adverse effects (e.g., nephrotoxic or hepatotoxic drugs).

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.