ARYOTRUST™

Description

AryoTrust™ is a biosimilar product with the generic name of Trastuzumab. AryoTrust™ is a recombinant DNA-derived humanized monoclonal antibody that selectively targets the extracellular domain of the human epidermal growth factor receptor 2 protein (HER2). These receptors are normally present on the normal cell surfaces leading to cellular growth and proliferation. Over-expression of HER2 is observed in primary breast and advanced gastric cancer cells. A consequence of HER2 gene amplification is an increase in HER2 protein expression on the surface of these tumor cells, which results in a constitutively activated HER2 receptor and growth of cancerous cells. By binding to HER2, AryoTrust prevents its activity leading to death of cancerous cells.

Indication

AryoTrust™ is used for:

• HER2 over-expressing early breast cancer
• HER2 over-expressing metastatic breast cancer
• HER2 over-expressing metastatic gastric cancer

AryoTrust™ is produced in the form of lyophilized powder for concentrate for solution for infusion in two dosages of 150 mg and 440 mg which is administered as intravenous infusion after dilution. Each single use vial of 150 mg AryoTrust contains 150 mg Trastuzumab and should be diluted with 7.2 ml of sterile Water for Injections. Each small box contains 1 vial of powder and a patient information leaflet. AryoTrust 440 mg contains 440 mg Trastuzumab and should be diluted with 20 ml of Bacteriostatic Water for Injection (BWFI). Each small box contains 1 vial of powder, 1 vial of BWFI and a patient information leaflet.