|Herceptin||Powder, for solution||440 mg||Intravenous||Hoffmann La Roche|
|Herceptin||Injection, powder, lyophilized, for solution||150 mg/7.4mL||Intravenous||Genentech, Inc.|
|Herceptin||Injection, powder, for solution||150 mg||Intravenous||Roche Registration Limited|
|Herceptin||Injection, solution||600 mg||Subcutaneous||Roche Registration Limited|
A recombinant IgG1 kappa, humanized monoclonal antibody that selectively binds with high affinity in a cell-based assay (Kd = 5 nM) to the extracellular domain of the human epidermal growth factor receptor protein. Produced in CHO cell culture. In December 2017, FDA approved Ogivri (trastuzumab-dkst) as a biosimilar to Herceptin (trastuzumab) for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). It displays biosimilar properties as Herceptin according to clinical data. While Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer, it is the second biosimilar approved in the U.S. for the treatment of cancer.
Cancer, Breast; Metastatic Breast Cancer (MBC); Metastatic Gastroesophageal Junction Adenocarcinoma
Peak and trough plasma concentrations at steady state (between weeks 16 and 32) approximately 123 and 79 mcg/mL, respectively.
Most likely removed by opsonization via the reticuloendothelial system.
Administration of trastuzumab can result in ventricular dysfunction and congestive heart failure. Risk of cardiotocity is especially elevated in patients recieving concurrent anthracycline or cyclophosphamide therapy.