Sotrovimab

Injection, 500 mg, for intravenous use

Emergency Use Authorization (EUA) for the Treatment of COVID-19

AUTHORIZED USE

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.

Important Information About Sotrovimab

  • Sotrovimab is not FDA-approved and is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.    

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. In response, the FDA has issued this EUA, as requested by GlaxoSmithKline, for the unapproved product, sotrovimab, for the treatment of mild-to-moderate 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. As a healthcare provider, you must comply with the mandatory requirements of this EUA.

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that sotrovimab may be effective for the treatment of mild-to-moderate COVID-19 in certain at-risk patients as specified in the Fact Sheet for Healthcare Providers. You may be contacted and asked to provide information to help with the assessment of the use of the product during this emergency.


This EUA for sotrovimab will end when the Secretary determines that the circumstances justify the EUA no longer exist or when there is a change in the approval status of the product such that an EUA may no longer be needed.

INSTRUCTIONS FOR HEALTHCARE PROVIDERS

As the healthcare provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the Fact Sheet for Patients, Parents and Caregivers (and provide a copy of the Fact Sheet) prior to the patient receiving sotrovimab, including:

  • FDA has authorized the emergency use of sotrovimab for the treatment of mild-to-moderate 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 [see Limitations of Authorized Use].
  • The patient or parent/caregiver has the option to accept or refuse sotrovimab.
  • The significant known and potential risks and benefits of sotrovimab and the extent to which such risks and benefits are unknown.
  • Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.
  • Patients treated with sotrovimab should continue to self-isolate and use infection control measures (eg, wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines.

For information on clinical trials that are testing the use of sotrovimab for COVID-19, please see www.clinicaltrials.gov.

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