On May 26, 2021, The U.S. Food and Drug Administration (FDA) authorized the emergency use of sotrovimab for the treatment of COVID-19 under an emergency use authorization (EUA) PDF.
Sotrovimab is an investigational anti-SARS-CoV-2 monoclonal antibody used to treat mild-to-moderate symptoms of COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk of progression to severe COVID-19, including hospitalization or death. Treatment should be initiated as soon as possible after a positive viral test for SARS-CoV2 (either antigen or molecular PCR test) and within 10 days of symptom onset.
Clinical Trial Data
Treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalization or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial.
Sotrovimab and SARS-CoV-2 Variants
Sotrovimab is expected to be effective against all variants currently circulating in California, including Omicron.
Additional Use Considerations
Sotrovimab is authorized for treatment only; sotrovimab is not authorized for post-exposure prophylaxis. The Fact Sheet for Health Care Providers (PDF), which includes variant data as well as the full conditions of use, should be reviewed prior to administration of the medication.
The following should be considered:
- Treatment should be initiated as soon as possible after a positive viral test for SARS-CoV2 (either antigen or PCR test) and within 10 days of symptom onset. CDPH recommends initiating treatment as soon as the positive results have been obtained, as early treatment is expected to have the most benefit.
- High-risk criteria include older age, being overweight/obese, pregnancy, chronic kidney disease, diabetes, immunosuppression, cardiovascular disease or hypertension, chronic lung diseases, sickle cell disease, neurodevelopmental disorders, having a medical-related technological dependence, or other medical conditions or factors (for example, race or ethnicity) that may also place individual patients at high risk for progression to severe COVID-19. Authorization for use of anti-SARS-CoV-2 monoclonal antibody treatment is not limited to the medical conditions or factors listed above. Healthcare providers should consider the benefit-risk for an individual patient. For more information, please see the Fact Sheet for Health Care Providers (PDF).
- Sotrovimab is administered intravenously.
- Sotrovimab is not authorized for use in patients who are hospitalized due to COVID-19, who require oxygen therapy due to COVID-19, or who require an increase in baseline oxygen flow rate due to COVID-19. Treatment is also not authorized for COVID-19 positive asymptomatic patients.
- Sotrovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis.
- Patients are clinically monitored during treatment and observed for 60 minutes after infusion is complete. While rare, there is the potential for serious hypersensitivity reactions, including anaphylaxis (see full EUA prescribing information in the Fact Sheet for Health Care Providers [PDF]).
- Health care providers are responsible for mandatory FDA MedWatch reporting of all medication errors and serious adverse events or deaths considered to be potentially attributable to sotrovimab.
- Health care providers must communicate information consistent with the Fact Sheet for Patients, Parents and Caregivers (PDF) and provide a copy prior to the patient receiving sotrovimab
Patient Prioritization During Times of Limited Supply
The National Institutes of Health (NIH) treatment guidelines on prioritization should be followed during times when supply is limited.
Distribution amounts for each state/territory are determined by the US Department of Health and Human Services (HHS). The California Department of Health (CDPH) will be allocating product to local jurisdictions, once the number of doses has been allocated, each jurisdiction's Medical and Health Operational Area Coordinator (MHOAC) will assist in determining which facilities within the jurisdiction receive product.
Originally published on January 19, 2022