Nimotuzumab is indicated for use in the treatment of advanced Squamous Cell Carcinoma of Head and Neck region with concurrent chemotherapy and/or radiotherapy.
Nimotuzumab is administered as continuous intravenous (IV) infusions in weekly doses of 200 mg for 6 weeks, in combination with a standard radiotherapy and/or chemotherapy for head and neck cancers. 200 mg of the antibody is diluted in 250 ml of sodium chloride and infused over 60 minutes.
During dilution with normal saline ensure that all precautions are taken to avoid accidental contamination. In case of any turbidity being seen in the solution it is due to accidental microbial contamination. In such case please discard the solution and prepare a fresh solution.
It has been demonstrated in completed clinical trials the dosage upto 400 mg are safe to humans. No conclusion is available now about the safety for doses above 400 mg.
BIOMab EGFR (Nimotuzumab) should be stored in a refrigerator at temperature between 2°C and 8°C. Do not freeze. Freezing and thawing will destroy the biological activity of Nimotuzumab.
Nimotuzumab diluted in sodium chloride solution is physically and chemically stable for 12 hours under 2~8°C, and for 6 hours at room temperature (25 ± 3°C). Nimotuzumab may not be active in the prepared solution beyond these conditions, the solution should be discarded and fresh solution prepared for infusion.
Shelf life: 24 months.
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