1. Medicinal Product Name
CIMAher® (Nimotuzumab)
2. What This Medicine Is & What It Is Used For
CIMAher® is a humanised monoclonal antibody that targets the Epidermal Growth Factor Receptor (EGFR), a protein that plays a key role in the growth of many solid tumours. By blocking EGFR activation, it helps slow or stop tumour cell growth.
Indications:
- Advanced head and neck tumours (with radiotherapy and/or chemotherapy)
- High-grade glial tumours, including glioblastoma multiforme
- Paediatric high-grade glial tumours when other treatments are not effective
- Unresectable oesophageal tumours
- Locally advanced or metastatic pancreatic adenocarcinoma (with chemotherapy)
Note: Effectiveness depends on EGFR expression in the tumour.
3. Composition & How It Is Given
Each vial contains 50 mg of Nimotuzumab in 10 mL solution for intravenous use.
Excipients include:
- Monobasic and dibasic sodium phosphate
- Sodium chloride
- Polysorbate-80
- Water for injection
Administration route: Intravenous (IV) infusion.
4. Dosage & Administration
Dosing is determined case-by-case by the treating specialist. Below are common schedules used in clinical practice:
Standard schedules:
- Head & neck tumours: 200 mg weekly for 6 weeks, then maintenance every 14 days
- Glioblastoma / anaplastic astrocytoma (adults): 200 mg weekly for 6 weeks with radiotherapy, then every 14 days
- Paediatric high-grade glial tumours: 150 mg/m² weekly for 6 weeks, then every 14 days
- Pancreatic adenocarcinoma: 400 mg weekly with chemotherapy
Important: Patient organ function, tolerance and response must be evaluated regularly.
5. Contraindications & Precautions
- Hypersensitivity to Nimotuzumab or its components
- Previous reactions to monoclonal antibodies
- Use in pregnancy or breastfeeding is not recommended
- Caution in uncontrolled cardiac, renal or metabolic disease
6. Possible Side Effects
CIMAher® is generally well tolerated. Most side-effects are mild and manageable.
Reported side effects may include:
- Fever, chills, nausea, vomiting
- Blood pressure changes
- Increased liver enzymes
- Fatigue
- Headache
- Rarely: weakness, speech difficulty, phlebitis
Notably: Severe skin toxicity is rarely seen compared to other EGFR-inhibitors.
7. How It Works (Mechanism of Action)
Nimotuzumab attaches to the external part of EGFR and blocks the binding of natural ligands such as EGF. This prevents activation of the EGFR-tyrosine kinase pathway, which results in reduced:
- tumour cell proliferation
- angiogenesis
- invasion
- metastatic potential
- tumour survival signalling
8. Storage, Handling & Disposal
- Store between 2°C and 8°C
- Do not freeze
- Protect from light
- Inspect visually before administration
- Dispose of unused product based on biological agent guidelines
9. Patient Guidance – Key Points to Communicate
- This is not a stand-alone cure; it forms part of a treatment plan
- Often used with radiotherapy or chemotherapy
- Monitoring during treatment is essential
- Side effects are normally manageable when detected early
10. Quick Summary
- CIMAher® is an anti-EGFR antibody used for several advanced cancers
- Given by IV under specialist supervision
- Has distinct dosing protocols depending on tumour type
- Fewer severe skin toxicities compared to some similar drugs
- Needs refrigerated storage and visual inspection before use