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sotrovimab

Indications: - outpatients > 11 years of age with mild to moderate COVID-19* - positive laboratory confirmation - high risk of progression to hospitalization or death * emergency use authorization Contraindications: - not authorized for use in hospitalized patients - not authorized for use in areas with high prevalence of Omicron BA.2 [4] - not authorized for use in U.S due to high prevalence of Omicron BA.2 [] Dosage: - 500 mg IV infusion Vials 500 mg/8 mL Storage: Refrigerate unopened vials at 2-8 degrees C in original carton Do not freeze or shake. Protect from light. Antimicrobial activity: - SARS-CoV2 variants, including those from the U.K., South Africa, Brazil, California, New York, & India Adverse effects: - hypersensitivity reactions, including anaphylaxis [2] Drug interactions: - clinical drug-drug interaction studies have not been performed Mechanism of action: - monoclonal antibody to spike glycoprotein of SARS-CoV2 (COVID-19) Notes: - GlaxoSmithKline

Interactions

drug adverse effects of pharmaceutical monoclonal antibodies

General

monoclonal antibody to spike glycoprotein of SARS-CoV2 (COVID-19)

References

  1. Walker M FDA Allows New Antibody in Less-Severe COVID-19. Sotrovimab prevented severe outcomes, promising against variants, agency said. https://www.medpagetoday.com/infectiousdisease/covid19/92811 - Reuters Staff US FDA Gives Emergency Use Approval for GSK-Vir COVID-19 Antibody Drug. Medscape. May 27, 2021 https://www.medscape.com/viewarticle/951977 - FDA News Release. May 26, 2021 Coronavirus (COVID-19) Update: FDA Authorizes Additional Monoclonal Antibody for Treatment of COVID-19. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-monoclonal-antibody-treatment-covid-19
  2. Dolgin E 'Super-antibodies' could curb COVID-19 and help avert future pandemics. Nature Biotechnology 2021 39:783-785. June 22 PMID: 34158667 PMCID: PMC8218965 Free PMC article https://www.nature.com/articles/s41587-021-00980-x
  3. Gupta A, Gonzalez-Rojas Y, Juarez E et al. Early treatment for Covid-19 with SARS-CoV-2 neutralizing antibody sotrovimab. N Engl J Med 2021 Oct 27; [e-pub] PMID: 34706189 https://www.nejm.org/doi/10.1056/NEJMoa2107934
  4. Walker M FDA Scales Back Sotrovimab Use for High-Risk Covid Treatment no longer authorized for use in areas with high prevalence of BA.2. MedPage Today February 24, 2022 https://www.medpagetoday.com/infectiousdisease/covid19/97345
  5. Gupta A, Gonzalez-Rojas Y, Juarez E et al Effect of Sotrovimab on Hospitalization or Death Among High-risk Patients With Mild to Moderate COVID-19. A Randomized Clinical Trial. JAMA. Published online March 14, 2022 PMID: 35285853 https://jamanetwork.com/journals/jama/fullarticle/2790246
  6. Crist C US Pulls COVID Drug as Omicron Subvariant Spreads. Medscape. April 6, 2022 https://www.medscape.com/viewarticle/971707
  7. Birnie E, Biemond JJ, Appelman B et al Development of Resistance-Associated Mutations After Sotrovimab Administration in High-risk Individuals Infected With the SARS-CoV-2 Omicron Variant. JAMA. Published online August 1, 2022 PMID: 35913747 https://jamanetwork.com/journals/jama/fullarticle/2794999
  8. FACT SHEET FOR HEALTHCARE PROVIDERSEMERGENCY USE AUTHORIZATION (EUA) OF SOTROVIMAB https://www.fda.gov/media/149534/download