Product Information
Registration Status: ActiveTYSABRI CONCENTRATE FOR SOLUTION FOR INFUSION 300MG/15ML is approved to be sold in Singapore with effective from 2013-11-09. It is marketed by EISAI (SINGAPORE) PTE LTD, with the registration number of SIN14408P.
This product contains Natalizumab 300mg/15mL in the form of INFUSION, SOLUTION CONCENTRATE. It is approved for INTRAVENOUS use.
This product is manufactured by Vetter Pharma-Fertigung GmbH & Co. KG 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
Humanized IgG4k monoclonal antibody produced in murine myeloma cells. Natalizumab contains human framework regions and the complementarity-determining regions of a murine antibody that binds to a4-integrin. Natalizumab was voluntarily withdrawn from U.S. market because of risk of Progressive multifocal leukoencephalopathy (PML). It was returned to market July, 2006.
Indication
For treatment of multiple sclerosis.
Mechanism of Action
Binds to the α4-subunit of α4b 1 and α4b 7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the α4-mediated adhesion of leukocytes to their counter-receptor(s).
Clearance
* 16 +/- 5 mL/hour [patients with MS who did not have PML receiving the repeat IV administration of a 300 mg dose] * 22 +/- 22 mL/hour [Patients with Crohn's Disease receiving the repeat IV administration of a 300 mg dose]
Active Ingredient/Synonyms
Anti-alpha4 integrin | Anti-VLA4 | Natalizumab |
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.