Sotrovimab Frequently Asked Questions

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  • What is an Emergency Use Authorization?

    The FDA has made sotrovimab available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Services (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. Sotrovimab has not undergone the same type of review as an FDA-approved medicine. In issuing an EUA under the COVID-19 public health emergency, the FDA must determine, among other things, that based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved, and available alternatives. All of these criteria must be met to allow for the medicine to be used in the treatment of patients during the COVID-19 pandemic.

     

    The EUA for sotrovimab is in effect for the duration of the COVID-19 declaration justifying emergency use of these medicines, unless terminated or revoked (after which the products may no longer be used).

  • What is the mechanism of action of sotrovimab?

    Sotrovimab is a recombinant human IgG1κ monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2. Sotrovimab does not compete with human ACE2 receptor binding.

  • Who is eligible for treatment with sotrovimab under the EUA?

    Sotrovimab is authorized for use under an Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

    Limitations of Authorized Use

    • Sotrovimab is not authorized for use in patients:
      • who are hospitalized due to COVID-19, OR
      • who require oxygen therapy due to COVID-19, OR
      • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non–COVID-19 related comorbidity).
    • Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID‑19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID‑19 requiring high flow oxygen or mechanical ventilation.

    For more information on patient selection, please see the Fact Sheet for Healthcare Providers.

  • Where can I find sotrovimab?

    Call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) for help locating an infusion center that can provide treatment with sotrovimab.

  • What clinical trials are currently ongoing with sotrovimab for the treatment of COVID-19?

    For information on the sotrovimab clinical trials, please click here.

  • What are the interim data from the clinical trials?

    Results can be found in the Fact Sheet for Healthcare Providers. For more information, contact GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) or visit GSK MedInfo.

  • What adverse reactions have been identified thus far (in the randomized trials)?

    Safety information can be found in the Important Safety Information below, as well as in the Fact Sheet for Healthcare Providers. For more information, contact GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) or visit GSK MedInfo.

  • How do I report medication errors and serious adverse events?

    Reporting Adverse Events:

    The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory reporting of all medication errors and serious adverse events potentially related to sotrovimab within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words “Sotrovimab use for COVID-19 under Emergency Use Authorization (EUA)” in the description section of the report.

    • Submit adverse event reports to FDA MedWatch using one of the following methods:
    • In addition, please provide a copy of all FDA MedWatch forms to:

      GlaxoSmithKline, Global Safety
      Fax: 919-287-2902
      Email: WW.GSKAEReportingUS@gsk.com
      Or call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) to report adverse events.

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To learn more about COVID-19, visit the CDC and WHO websites.