Sotrovimab
Links to latest country guidance for sotrovimab authorization, treatment, and product information
August 2022
An Overview and Background
Sotrovimab is an antibody drug approved for use in people who are infected with SARS-CoV2 (the virus that causes COVID-19) and are considered high risk to experience mild to severe symptoms resulting from the 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-CoV2 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 track, 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 see the table below:
Country |
Latest Country Guidance |
Product Information Factsheet for Patients and Caregivers |
Product Information Factsheet for Healthcare Professionals |
|---|---|---|---|
|
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 (MHLW) https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000121431_00111.html |
Source: Japan - GSKpro.com/ja-jp https://gskpro.com/ja-jp/products-info/xevudy/ |
Source: Japan - GSKpro.com/ja-jp https://gskpro.com/ja-jp/products-info/xevudy/ |
|
Singapore 
|
Source: National Centre for Infectious Diseases, Singapore Treatment Guidelines for COVID-19 v10.1 -for circulation_Final [29-8-2022].pdf (ncid.sg) |
Source: Singapore – GSK.com Sotrovimab-fact-sheet-for-patients-and-caregivers-hsa.pdf (gskpro.com) |
Source: Singapore – GSK.com https://gskpro.com/content/dam/global/hcpportal/en_SG/sotrovimab-fact-sheet-for-healthcare-professionals-hsa.pdf |
|
UK (English) 
|
Source: MHRA Non-hospitalised COVID-19 patients CAS-ViewAlert (mhra.gov.uk) Hospital-onset COVID-19 patients Source: NHS England CAS-ViewAlert (mhra.gov.uk) |
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 
|
Source: Food and Drug Administration FDA updates Sotrovimab emergency use authorization | FDA |
Source: Food and Drug Administration FACT SHEET FOR PATIENTS, PARENTS, AND CAREGIVERS EUA of Sotrovimab for the Treatment of COVID-19 (fda.gov) |
Source: Food and Drug Administration GSK Sotrovimab Fact Sheet for HCP 03252022 (fda.gov) |
