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 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)