Cimaher Special Precautions

Cimaher (Nimotuzumab) 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 this product or other products derived from NSO mammalian cells or any component of this product. Cimaher (Nimotuzumab) should be used with caution in patients with chronic diseases in decompensate phase, such as cardiac dysfunction, diabetes mellitus or arterial hypertension or in patients with history of severe allergies reaction.
The product should be applied under the supervision of skilled clinical doctors.
Pediatric use: A phase II clinical study in pediatric patients with brain tumors is done and showed no significant adverse events related to Nimotuzumab. Efficacy in heavily pretreated 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 non-hematological 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.