CIMAher, is a humanized immunoglobillin, IgG1 isotype that recognizes a sequence located in the external domain of the human EGF receptor (EGF-R), this antibody binds to its receptor with an affinity of 109 L / mol. CIMAher blocks the binding of EGF to the EGF receptor, inhibits the activation of receptor tyrosine kinase activity induced by EGF binding, and inhibits tumor growth in xenograft human tumor models in immunodeficient and athymic mice.
CIMAher induces an objective anti-tumor response (partial or total remission). In combination with radiotherapy the objective response is increased and no evidence of severe clinical toxicity was observed.
Therapeutic indication: It is indicated in the treatment of head and neck tumors in advanced stages in combination with radiotherapy and / or chemotherapy. Treatment of high-grade astrocytoma as monotherapy in children refractory to oncospecific treatment and of glioblastoma multiforme in combination with radiotherapy in adult patients and in the treatment of esophageal tumors.
Pharmacological category: Sterile injectable solution for intravenous use
Presentation: Each 10 mL nimotuzumab bulb contains a sterile 50 mg solution of purified, colorless monoclonal antibody, dissolved in a buffer solution (pH 7.0 ± 0.5) of monobasic phosphate sodium (18.0 mg), dibasic sodium phosphate (4.5 mg), sodium chloride (86.0 mg), and polysorbate 80 (2.00 mg) in water for injections.
The production of this medicine is carried out under the international recommendations of Good Manufacturing Practices (GMP) and Good Laboratory Practices. Humanized monoclonal antibody anti Epidermal Growth Factor receptor (EGFR)