Sotrovimab Injection
Dosage form: injection, solution, concentrate
Drug class:Miscellaneous antivirals
Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.
On This Page
- Contraindications
- Dosage and Administration
- Warnings
- Adverse Reactions/Side Effects
- Dosage Forms and Strengths
- Warnings and Precautions
- Drug Interactions
- Use In Specific Populations
- Overdosage
- Description
- Clinical Pharmacology
- Nonclinical Toxicology
- Clinical Studies
- How Supplied/Storage and Handling
- Patient Counseling Information
AUTHORIZED USE
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product sotrovimab 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
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- Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency [seeMicrobiology/Resistance Information (15)].
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- FDA’s determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs. 1
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- Sotrovimab is not authorized for use in the following patient populations:
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- Adults or pediatric patients who are hospitalized due to COVID-19, OR
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- Adults or pediatric patients who require oxygen therapy and/or respiratory support due to COVID-19, OR
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- Adults or pediatric patients who require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those patients on chronic oxygen.
