Skip Navigation LinksCasirivimab-Imdevimab-Fact-Sheet




State of Cal Logo
EDMUND G. BROWN JR.
Governor

State of California—Health and Human Services Agency
California Department of Public Health


November 5, 2021


TO:
All Californians

SUBJECT:
California Department of Public Health Casirivimab and Imdevimab Distribution Fact Sheet



Casirivimab/imdevimab (REGEN-COV) is an investigational monoclonal antibody cocktail that has been engineered to bind to and neutralize SARS-CoV-2 and prevent progression to severe illness. The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) (PDF) on November 21, 2020 for the use of casirivimab/imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. 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

Clinical trial data in outpatients have shown that casirivimab/imdevimab may reduce viral load and/or COVID-19 medically attended visits. Clinical trial data in hospitalized patients, however, have not shown a benefit with casirivimab/imdevimab use in patients requiring high-flow oxygen or mechanical ventilation, and it is not authorized for use in patients who are hospitalized due to COVID-19.

Post-Exposure Prophylaxis

On August 10, 2021, the FDA revised the EUA for casirivimab/imdevimab to include post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

Post-exposure prophylaxis can be given to high-risk individuals if:

  1. They have been exposed to an individual infected with SARS-CoV-2 consistent with the Centers for Disease Control and Prevention (CDC) close contact criteria (less than 6 feet away from infected person for a cumulative total of 15 minutes or more over a 24-hour period); OR
  2. They are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting.

Use of casirivimab/imdevimab as a post-exposure prophylaxis is not a replacement for COVID-19 vaccination. The product should not be used as a pre-exposure prophylaxis.

Additional Use Considerations

The FDA EUA includes additional information on in vitro susceptibility of SARS-CoV-2 variants to each of the monoclonal antibody therapies. The revised Fact Sheet for Health Care Providers (PDF), which includes this data as well as the full conditions of use, should be reviewed prior to administration of the medication. 

Other considerations of use include the following:

  • 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. 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 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).
  • Casirivimab/imdevimab can be administered intravenously or subcutaneously.
  • Casirivimab/imdevimab is not authorized for use in patients who are hospitalized due to COVID-19 or who require oxygen therapy due to COVID-19. Treatment is also not authorized for COVID-19 positive asymptomatic patients.
  • Casirivimab/imdevimab 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 or subcutaneous injection. There is the potential for serious hypersensitivity reactions, including anaphylaxis, with casirivimab/imdevimab administration (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 casirivimab/imdevimab.
  • 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 casirivimab/imdevimab.

NIH Treatment Guidelines Panel Recommendations

The NIH COVID-19 Treatment Guidelines Panel recommends using one of the following anti-SARS-CoV-2 mAb regimens (listed alphabetically) to treat non-hospitalized patients with mild to moderate COVID-19 who are at high risk of clinical:

  • Bamlanivimab 700 mg plus etesevimab 1,400 mg intravenous (IV) infusion in regions where the combined frequency of potentially resistant variants is low (currently approved for use in California, see the list of authorized regions here (PDF)); or
  • Casirivimab 600 mg plus imdevimab 600 mg IV infusion or subcutaneous injection; or
  • Sotrovimab 500 mg IV infusion

The Panel also states the following:

  • Treatment should be started as soon as possible after the patient receives a positive result on a SARS-CoV-2 antigen or nucleic acid amplification test (NAAT) and within 10 days of symptom onset.
  • The Panel recommends against the use of anti-SARS-CoV-2 monoclonal antibodies for patients who are hospitalized because of COVID-19, except in a clinical trial. However, their use should be considered for persons with mild to moderate COVID-19 who are hospitalized for a reason other than COVID-19 but who otherwise meet the EUA criteria.

Infectious Diseases Society of America (IDSA) Guideline Panel Recommendations

The Infectious Diseases Society of America (IDSA) Guideline Panel recommends the use of bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease.

Acquiring Casirivimab/Imdevimab for EUA Use

Given high demand and limited supply, the U.S. Department of Health and Human Services (HHS) announced that effective September 13, 2021, distribution of the anti-SARS-CoV-2 monoclonal antibody products casirivimab plus imdevimab (PDF) and bamlanivimab plus etesevimab will transition to a state/territory-coordinated distribution system. Facilities can no longer directly order this product.

Weekly distribution amounts for each state/territory will be determined by HHS based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and use submitted to the federal government.

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 Decemeber 31, 2020