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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.