Sotrovimab

Links to latest country guidance for sotrovimab authorization, treatment, and product information

November 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
(English)

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: Therapeutic Goods Association (TGA), Department of Health and Aged Care, Australian Government

XEVUDY Product Information (tga.gov.au)

Canada
(English)

Source: Government of Canada

Sotrovimab (sotrovimab) | COVID-19 vaccines and treatments portal (canada.ca)

Source: Canada – ca.gsk.com/en-ca

Sotrovimab for Injection | GSK Canada

Source: Canada – ca.gsk.com/en-ca

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 – ca.gsk.com/fr-ca

Sotrovimab pour Injection | GSK Canada

Source: Canada – ca.gsk.com/fr-ca

Sotrovimab pour Injection | GSK Canada

Denmark
(Danish)

Source: Danish Health Authority

https://www.sst.dk/da/corona/test-symptomer-og-tidlig-behandling/tidlig-behandling

Source: European Medicines Agency

https://www.ema.europa.eu/en/documents/product-information/xevudy-epar-product-information_da.pdf

Source: European Medicines Agency

https://www.ema.europa.eu/en/documents/product-information/xevudy-epar-product-information_da.pdf

Germany
(English)

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
(German)

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)

Italy
(Italian)

Source: Italian Medicines Agency

Uso degli anticorpi monoclonali per COVID-19 | Agenzia Italiana del Farmaco (aifa.gov.it)

Source: Italy - xevudy.eu/it-it/

Italy (xevudy.eu)

Source: Italy - xevudy.eu/it-it/

Italy (xevudy.eu)

Japan
(Japanese)

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
(English)

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
(English)

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)