Nimotuzumab (TheraCIM® h-R3)
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by theracimnimotuzumab_h75dq5 | Sep 2, 2018 | Uncategorized

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    Important Safety Information

    © 2023 | TheraCIM® Nimotuzumab

    Adverse Reactions

    Nimotuzumab has been found to be very well tolerated in most clinical trials.

    Adverse reactions seen in 58% of patients in a Phase I trial after a single dose of 50 to 400 mg of Nimotuzumab included:

    • Tremors
    • Fever
    • Nausea and vomiting
    • Dryness of mouth
    • Asthenia
    • Hypertension
    • Flushing

    All adverse events were mild to moderate and were considered infusion reactions. No patient developed acne-form rash or other dermatological toxicity. (Crombet et al. 2004) Similar adverse event profile was seen in further clinical trials with Nimotuzumab. Grade 3 somnolence was reported in one patient following a 400 mg dose of Nimotuzumab. (Crombet et al. 2003)

    In a Phase II trial, the most common adverse reactions were fever (4.28%), dizziness and hypotension (2.86%) and mild skin rash (1.43%). (Guozhen X, Li G , 2004) One case of anaphylactic reaction with skin rash requiring discontinuation of therapy was seen in a phase II clinical trial. (Clinigene International, 2006).

    These adverse reactions respond to treatment with conventional doses of analgesics and antihistamines.

     

    References

    • Crombet, Tania, Marta Osorio, Teresa Cruz, Carlos Roca, Ramón del Castillo, Rosa Mon, Normando Iznaga-Escobar, et al. 2004. “Use of the Humanized Anti-Epidermal Growth Factor Receptor Monoclonal Antibody h-R3 in Combination with Radiotherapy in the Treatment of Locally Advanced Head and Neck Cancer Patients.” Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology. https://doi.org/10.1200/JCO.2004.03.089.
    • Crombet, Tania, Leonel Torres, Elia Neninger, Mauricio Catalá, María E. Solano, Alejandro Perera, Olga Torres, et al. 2003. “Pharmacological Evaluation of Humanized Anti-Epidermal Growth Factor Receptor, Monoclonal Antibody h-R3, in Patients With Advanced Epithelial-Derived Cancer.” Journal of Immunotherapy. https://doi.org/10.1097/00002371-200303000-00006.
    • Guozhen X, Li G. PhaseII trial of recombinant humanized anti-human epidermal growth factor receptor monoclonal antibody (h-R3). Tumour hospital, China Academy of Medical Science. 2004: 1-72.
    • Clinigene International Pvt Ltd. An open-label, randomized, multicentric study to assess the safety and efficacy of h-R3 in combination with chemotherapy and radiotherapy or radiotherapy alone in patients with advanced (stage III or IVA) histologically documented squamous cell carcinoma of head and neck (SCCHN). 2006:1-90.