Product Information
Registration Status: ActiveAVASTIN CONCENTRATE FOR SOLUTION FOR INFUSION 400MG/16ML is approved to be sold in Singapore with effective from 2012-06-02. It is marketed by ROCHE SINGAPORE PTE LTD, with the registration number of SIN14097P.
This product contains Bevacizumab 400mg in the form of INFUSION, SOLUTION CONCENTRATE. It is approved for INTRAVENOUS use.
This product is manufactured by Genentech Inc. in UNITED STATES,F. Hoffmann-La Roche Ltd in SWITZERLAND, andF. Hoffmann-La Roche Ltd in GERMANY.
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 humanized monoclonal IgG1 antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF). Bevacizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to VEGF. Bevacizumab is produced in a Chinese Hamster Ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin and has a molecular weight of approximately 149 kilodaltons.
Indication
As part of combination therapy for metastatic colorectal cancer and HER2-negative metastatic breast cancer.
Mechanism of Action
Bevacizumab contains human framework regions with antigen binding regions of a humanised murine antibody that binds to VEGF. Bevacizumab is produced by recombinant DNA technology in a Chinese hamster ovary mammalian cell expression system in a nutrient medium containing the antibiotic gentamicin and is purified by a process that includes specific viral inactivation and removal steps. Bevacizumab binds VEGF and prevents the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. This prevents blood vessel proliferation and in response retardation of metastatic tumor growth occurs.
Clearance
* 0.26 L/day [Male patients who received 1 to 20 mg/kg of Avastin weekly, every 2 weeks, or every 3 weeks] * 0.21 L/day [Female patients who received 1 to 20 mg/kg of Avastin weekly, every 2 weeks, or every 3 weeks] * 0.25 L/day [Patients with higher tumor burden who received 1 to 20 mg/kg of Avastin weekly, every 2 weeks, or every 3 weeks] * 0.2 L/day [patients with tumor burdens below the median who received 1 to 20 mg/kg of Avastin weekly, every 2 weeks, or every 3 weeks] Clearance varies by body weight, gender, and tumor burden. Increased clearance observed in men and in patients with higher tumor burden; however, no evidence of reduced efficacy.
Toxicity
Category C in pregnancy. No studies on lactating patients: recommended to discontinue the drug or discontinue lactation. No extensive studies in pediatrics. In geriatrics: increased risk of proteinuria, arterial thromboembolic events, as well as GI bleeding and sepsis among others.
Active Ingredient/Synonyms
antiVEGF | bevacizumab-awwb | Bevacizumab |
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.