Product Information

Registration Status: Active

OGIVRI™ LYOPHILIZED POWDER FOR INJECTION 440MG PER VIAL is approved to be sold in Singapore with effective from 2019-11-04. It is marketed by MYLAN PHARMACEUTICALS PTE LTD, with the registration number of SIN15850P.

This product contains Trastuzumab 440 mg/vial in the form of INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION. It is approved for INTRAVENOUS use.

This product is manufactured by Biocon Limited (Powder and Diluent) in INDIA.

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.



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.


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.


Peak and trough plasma concentrations at steady state (between weeks 16 and 32) approximately 123 and 79 mcg/mL, respectively.
* 44 mL/kg
Most likely removed by opsonization via the reticuloendothelial system.


Elimination may involve clearance of IgG through 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.

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.


  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank