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 by GlaxoSmithKline (GSK)\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.
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
(English)
|
Source: Government of Canada
Sotrovimab (sotrovimab) | COVID-19 vaccines and treatments portal (canada.ca)
|
Contains prescribing information, patient medication information, and other important communications regarding sotrovimab.
Sotrovimab for Injection | GSK Canada
|
Contains prescribing information, patient medication information, and other important communications regarding sotrovimab.
Sotrovimab for Injection | GSK Canada
|
|
Canada
(French)
|
Source: Gouvernement du Canada
Sotrovimab (sotrovimab) | Portail des vaccins et traitements pour la COVID-19 (canada.ca)
|
Source: Canada - GSK.com
Contient la monographie du produit, les renseignements sur le produit pour le patient, et d’autres informations concernant le sotrovimab.
Sotrovimab pour Injection | GSK Canada
|
Source: Canada - GSK.com
Contient la monographie du produit, les renseignements sur le produit pour le patient, et d’autres informations concernant le sotrovimab
Sotrovimab pour Injection | GSK Canada
|
|
Germany
(English)
|
Source: Paul Ehrlich Institute
RKI - Homepage
|
Source: Germany – GSKpro.com GI_Xevudy_500_mg_Konzentrat_zur_Herstellung_einer_Infusionslösung_072022 (gskpro.com) |
Source: European Medicines Agency https://www.ema.europa.eu/en/documents/product-information/xevudy-epar-product-information_en.pdf |
|
Germany
(German)
|
Source: Robert Koch Institute
RKI - Coronavirus SARS-CoV-2 - COVID-19: Therapiehinweise und Empfehlungen
|
Source: Germany – GSKpro.com GI_Xevudy_500_mg_Konzentrat_zur_Herstellung_einer_Infusionslösung_072022 (gskpro.com) |
Source: Germany – GSKpro.com Xevudy 500 mg Konzentrat zur Herstellung einer Infusionslösung (gskpro.com) |
|
Singapore
(English)
|
Source: National Centre for Infectious Diseases, Singapore
Treatment Guidelines for COVID-19 v9 -for circulation 28-4-2022.pdf (ncid.sg)
|
Source: Singapore – GSK.com Sotrovimab-fact-sheet-for-patients-and-caregivers-hsa.pdf (gskpro.com) |
Source: Singapore – GSK.com Sotrovimab-fact-sheet-for-patients-and-caregivers-hsa.pdf (gskpro.com) |
|
UK (English)
|
Source: NHS England
Coronavirus » Interim Clinical Commissioning Policy: Antivirals or neutralising monoclonal antibodies in the treatment of hospital-onset COVID-19 (england.nhs.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 (English)
|
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) |
