TheraCIM should be administered with caution in patients who have previously received treatment with the murine monoclonal antibody ior egf/r3, patients with previous notification of having hypersensitivity to nimotuzumab or other products derived from NSO mammalian cells or any component of TheraCIM. TheraCIM should be used with caution in patients with chronic diseases in decompensate phase eg, cardiac dysfunction, diabetes mellitus or arterial hypertension or in patients with history of severe allergic reaction.
TheraCIM should be applied under the supervision of skilled clinical doctors.
Use in pregnancy: Effects of nimotuzumab on pregnancy have not been studied. However, animal studies have shown that at the embryonic stage, lack of EGFR can cause lack of maturation of the epithelium and postnatal death. EGFR has been implicated in the control of prenatal development and hence may be essential for normal organogenesis, proliferation and differentiation in the developing embryo. Human IgG1 is known to cross the placental barrier; therefore, the antibody has the potential to be transmitted from the mother to the developing fetus. The use of nimotuzumab during pregnancy is not recommended. The antibody should only be given to a pregnant woman or any woman not employing adequate contraception if the potential benefit outweighs the potential risks to the fetus. If the patient becomes pregnant while receiving nimotuzumab, the patient should be informed of the potential hazard to the fetus and/or the potential risk of loss of the pregnancy.
Use in lactation: Nimotuzumab is secreted in human milk, therefore, it is not recommended for use in lactating women. No recommendation is made on the potential benefit versus risk of administering nimotuzumab to nursing mothers.
Use in children: A phase II clinical study in pediatric patients with brain tumors was done and showed no significant adverse events related to nimotuzumab. Efficacy in heavily pre-treated relapsed high grade gliomas in children and adolescents has been demonstrated in the phase II study. The repeated application of nimotuzumab as monotherapy was well tolerated and safe. The clinical deteriorations were mostly associated with complications of the tumor disease, tumor progressions or rarely, with another concomitant disease. In particular, no allergic reactions or severe skin or gastrointestinal toxicity were observed. No safety concerns arose from laboratory tests, vital signs or physical examination findings. No severe hematological or nonhematological side effects associated with the nimotuzumab monoclonal antibody were seen. A phase III study of newly diagnosed diffuse intrinsic pontine glioma in pediatric/adolescent is currently ongoing.