Administration of SC Tysabri (natalizumab) outside a clinical setting

SC Tysabri (natalizumab) administered by a healthcare professional outside a clinical setting (e.g. at home) may be considered for patients who have previously tolerated at least 6 doses of natalizumab well, i.e. who have not experienced hypersensitivity reactions.¹  

The decision for a patient to receive injections outside a clinical setting should be made after evaluation and recommendation by the specialized physician.¹ 

Healthcare professionals should be vigilant for the early signs and symptoms of progressive multifocal leukoencephalopathy (PML) and must complete the OCS Administration Checklist for each patient prior to each administration.¹  

TYSABRI (natalizumab) is indicated as single disease modifying therapy in adults with highly active relapsing remitting multiple sclerosis (RRMS) for the following patient groups: 

• Patients with highly active disease despite a full and adequate course of treatment with at least one disease modifying therapy (DMT) (for exceptions and information about washout periods see sections 4.4 and 5.1) or 
• Patients with rapidly evolving severe RRMS defined by 2 or more disabling relapses in one year, and with 1 or more Gadolinium enhancing lesions on brain Magnetic Resonance Imaging (MRI) or a significant increase in T2 lesion load as compared to a previous recent MRI

Prescription only medicinal product. Before prescription, please, read full Product Information that is available here: https://www.ema.europa.eu/en/documents/product-information/tysabri-epar-product-information_en.pdf

REFERENCE 

1. TYSABRI (natalizumab) Summary of Product Characteristics.