Sotrovimab

Kathryn Dzintars, Pharm.D., BCPS
Sotrovimab is a topic covered in the Johns Hopkins ABX Guide.

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INDICATIONS

FDA

The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of sotrovimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) with a positive SARS-CoV-2 test who are at high risk* for progressing to severe disease or hospitalization. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals.

*High risk is defined as:

  • Have a body mass index (BMI) ≥ 35
  • Have chronic kidney disease
  • Have diabetes
  • Have cardiovascular disease (including congenital heart disease) or hypertension
  • Have chronic lung disease
  • Are pregnant
  • Have sickle cell disease
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Have neurodevelopmental disorders
  • Are ≥65 years of age
  • Are ≥ 55 years of age AND have cardiovascular disease OR hypertension OR COPD/other chronic respiratory diseases

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

-- To view the remaining sections of this topic, please or --

INDICATIONS

FDA

The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of sotrovimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) with a positive SARS-CoV-2 test who are at high risk* for progressing to severe disease or hospitalization. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals.

*High risk is defined as:

  • Have a body mass index (BMI) ≥ 35
  • Have chronic kidney disease
  • Have diabetes
  • Have cardiovascular disease (including congenital heart disease) or hypertension
  • Have chronic lung disease
  • Are pregnant
  • Have sickle cell disease
  • Have immunosuppressive disease
  • Are currently receiving immunosuppressive treatment
  • Have neurodevelopmental disorders
  • Are ≥65 years of age
  • Are ≥ 55 years of age AND have cardiovascular disease OR hypertension OR COPD/other chronic respiratory diseases

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

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Last updated: August 7, 2021