REMS File
| Brand Name | Tysabri |
| Generic Name | natalizumab |
| Marketed by | Elan Corporation, PLC |
| NDA/BLA Holder | Biogen Idec |
| NDA/BLA Number | BLA 125104 |
| NDA/BLA Approval Date | 11/23/2004 |
| Status | Approved |
| Review Classification | Not Applicable |
| REMS Approval Date | 3/25/2009 |
| Class REMS | No |
| REMS Source Document | http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-6201.pdf |
| Boxed Warning? | Yes |
| Boxed Warning | WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY |
| Indication | Multiple Sclerosis (MS) (1.1) |
| Route of Administration | Intravenous Injection |
| Mechanism of Action | Natalizumab binds to the ?4-subunit of ?4?1 and ?4?7 integrins expressed on the surface of all leukocytes except neutrophils, and inhibits the ?4-mediated adhesion of leukocytes to their counter-receptor(s). The receptors for the ?4 family of integrins include vascular cell adhesion molecule-1 (VCAM-1), which is expressed on activated vascular endothelium, and mucosal addressin cell adhesion molecule-1 (MAdCAM-1) present on vascular endothelial cells of the gastrointestinal tract. Disruption of these molecular interactions prevents transmigration of leukocytes across the endothelium into inflamed parenchymal tissue. In vitro, anti-?4-integrin antibodies also block ?4-mediated cell binding to ligands such as osteopontin and an alternatively spliced domain of fibronectin, connecting segment-1 (CS-1). In vivo, natalizumab may further act to inhibit the interaction of ?4-expressing leukocytes with their ligand(s) in the extracellular matrix and on parenchymal cells, thereby inhibiting further recruitment and inflammatory activity of activated immune cells. |
| Risks | Progressive Multifocal Leukoencephalopathy (PML). |
| Risks (MedGuide Language) | TYSABRI increases your chance of getting a rare brain infection that usually causes death or severe disability. This infection is called progressive multifocal leukoencephalopathy (PML). |
| Approved Labeling | http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf |
| Medication Guide? | Yes |
| Medication Guide | http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125104s106lbl.pdf |
| Medication Guide Version | 2008 |
| Communication Plan? | Not Available |
| Communication Plan | Not Available |
| Elements to Assure Safe Use? | Not Available |
| Elements to Assure Safe Use | The TOUCH Program includes: * Only prescribers and patients enrolled in the TOUCH Prescribing Program can prescribe and receive TYSABRI * Only certain pharmacies and infusion sites authorized by the TOUCH Prescribing Program can dispense and infuse TYSABRI |
| Implementation System? | Not Available |
| Implementation System | Not Available |
| Assessment Program | Not Available |
| Assessment Program Timeline | Not Available |
| Branded Program | T.O.U.C.H. Presribing Program - TYSABRI Outreach: Unified Commitment to Health. |
| Program Description | Because of the risk of PML, TYSABRI is available only through the TOUCH Prescribing Program, which stands for TYSABRI Outreach: Unified Commitment to Health. TOUCH is a restricted distribution program focused on safety. The goal of the TOUCH Prescribing Program is to minimize the risk of PML. |
| Link to Branded Program | http://www.tysabri.com/tysbProject/tysb.portal/_baseurl/threeColLayout/SCSRepository/en_US/tysb/home/treatment-with-tysabri/touch-prescribing-program. |
| Deemed/Approved | Deemed |
| Approval Letters | http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/125104s067ltr.pdf |
Sources
REMS Document: from FDA Approved REMS
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm
Approval Letters: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)
Approved Labeling: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)
Medication Guide: from FDA Medication Guide Website
(http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/index.cfm?fuseaction=Search.Search_Drug_Name)
Previous page: REMS Directory Next page: REMS White Papers