Product Information
Registration Status: ActiveHERCEPTIN POWDER FOR INJECTION 440mg/VIAL is approved to be sold in Singapore with effective from 1999-07-19. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN11028P.
This product contains Trastuzumab 440mg/vial in the form of INJECTION, POWDER, FOR SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by GENENTECH INC in UNITED STATES, andF.Hoffmann-La Roche Ltd (Solvent only) in SWITZERLAND.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
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.
Indication
For treatment of early stage HER2-positive breast cancer, or metastatic breast cancer that substantially overexpress HER2.
Mechanism of Action
Trastuzumab binds to the HER2 (or c-erbB2) proto-oncogene, an EGF receptor-like protein found on 20-30% of breast cancer cells. The binding leads to antibody mediated (complement mediated) killing of the HER2 positive cells.
Pharmacokinetics
- Absorption
- Peak and trough plasma concentrations at steady state (between weeks 16 and 32) approximately 123 and 79 mcg/mL, respectively.
- Distribution
- * 44 mL/kg
- Metabolism
- Most likely removed by opsonization via the reticuloendothelial system.
- Elimination
Clearance
Elimination may involve clearance of IgG through the reticuloendothelial system.
Toxicity
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.
Active Ingredient/Synonyms
RHUMAB HER2 | trastuzumab-dkst | Trastuzumab |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.