Sotrovimab
Links to latest country guidance for sotrovimab authorization, treatment, and product information
May 2023
An Overview and Background
Sotrovimab is a medication approved for use in people who are infected with SARS-CoV-2 (the virus that causes COVID-19) and are considered high risk for experiencing severe COVID-19 infection.
Categorized as a monoclonal antibody (mAb), sotrovimab is produced in a laboratory and currently produced by GlaxoSmithKline (GSK) and Vir Biotechnology.
Engineered with a very specific three-dimensional shape, sotrovimab is designed to attach directly to a protein on the SARS-CoV-2 virus called the spike protein. The SARS-CoV-2 virus uses this spike protein to enter the cell and attach to a specific cell protein called ACE-2. Once the SARS-CoV-2 virus is inside an infected cell, it reproduces and then spreads to other cells.
Because the virus attaching to ACE-2 is initially what starts the process that leads to severe COVID-19, scientists and clinicians believe that giving it to people in the early stages of COVID-19 and who are at risk of progressing to severe COVID-19, can interrupt attachment to ACE-2. By attaching to the spike protein, sotrovimab effectively prevents the SARS-CoV-2 from attaching to ACE-2, found in cells of the body. If the interaction with ACE-2 is interrupted and prevented, then the virus may only cause mild symptoms, characterized by irritating your upper respiratory tract, as in any cold.
For the latest information on the availability of sotrovimab in your country, as well as further information about the product, please refer to the table below:
Country |
Latest Country Guidance |
Product Information Factsheet for Patients and Caregivers |
Product Information Factsheet for Healthcare Professionals |
|---|---|---|---|
|
Australia 
|
Source: National Clinical Evidence Taskforce - COVID-19 COVID-19 - National Clinical Evidence Taskforce |
Source: Department of Health and Aged Care, Australian Government XEVUDY Consumer Medicine Information (tga.gov.au) |
Source: National Clinical Evidence Taskforce - COVID-19 XEVUDY Product Information (tga.gov.au) |
|
Canada 
|
Source: Government of Canada Sotrovimab (sotrovimab) | COVID-19 vaccines and treatments portal (canada.ca) |
Source: Canada – ca.gsk.com/en-ca Contains prescribing information, patient medication information, and other important communications regarding sotrovimab. Sotrovimab for Injection | GSK Canada |
Source: Canada – ca.gsk.com/en-ca Contains prescribing information, patient medication information, and other important communications regarding sotrovimab. Sotrovimab for Injection | GSK Canada |
|
Canada
|
Source: Gouvernement du Canada Sotrovimab (sotrovimab) | Portail des vaccins et traitements pour la COVID-19 (canada.ca) |
Source: Canada – ca.gsk.com/fr-ca Sotrovimab pour Injection | GSK Canada |
Source: Canada – ca.gsk.com/fr-ca Sotrovimab pour Injection | GSK Canada |
|
Germany 
|
Source: Robert Koch Institute RKI - Coronavirus SARS-CoV-2 - COVID-19: Therapiehinweise und Empfehlungen |
Source: European Medicines Agency https://www.ema.europa.eu/en/documents/product-information/xevudy-epar-product-information_en.pdf |
Source: European Medicines Agency https://www.ema.europa.eu/en/documents/product-information/xevudy-epar-product-information_en.pdf |
|
Germany
|
Source: Robert Koch Institute RKI - Coronavirus SARS-CoV-2 - COVID-19: Therapiehinweise und Empfehlungen |
Source: Germany – GSKpro.com/de-de GSK | Xevudy (gskpro.com) |
Source: Germany – GSKpro.com/de-de GSK | Xevudy (gskpro.com) |
|
Japan 
|
Source: Ministry of Health, Labour and Welfare https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000121431_00111.html |
Source: GSKpro.com https://gskpro.com/ja-jp/products-info/xevudy/ |
Source: GSKpro.com https://gskpro.com/ja-jp/products-info/xevudy/ |
|
Singapore 
|
This product has been deauthorised in Singapore. For further updates, please refer to the following webpage on Singapore’s Health Sciences Authority (HSA) website: HSA | Emergency therapeutic products granted PSAR authorisation |
||
|
UK (English) 
|
Source: National Institute for Health and Care Excellence https://www.nice.org.uk/guidance/ta878 |
Source: UK Electronic Medicines Compendium Xevudy 500 mg concentrate for solution for infusion - Patient Information Leaflet (PIL) - (emc) (medicines.org.uk) |
Source: UK Electronic Medicines Compendium Xevudy 500 mg concentrate for solution for infusion - Summary of Product Characteristics (SmPC) - (emc) (medicines.org.uk) |
|
US 
|
This product has been deauthorised in the United States. For further updates, please refer to the following webpage on the U.S. Food and Drug Administration website: FDA updates Sotrovimab emergency use authorization | FDA |
Source: Sotrovimab Product Website https://www.sotrovimab.com/ |
Source: Food and Drug Administration GSK Sotrovimab Fact Sheet for HCP 03172023 (fda.gov) |
