Skip Navigation LinksBamlanivimab-plus-Etesevimab-Distribution-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 Bamlanivimab plus Etesevimab Distribution Fact Sheet



On February 25, 2021, Eli Lilly and Company received an Emergency Use Authorization (EUA, PDF) from the U.S. Food and Drug Administration (FDA) for the investigational monoclonal antibody (mAb) treatment bamlanivimab/etesevimab.

The EUA allows healthcare providers to administer bamlanivimab/etesevimab together to treat mild to moderate 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 progressing to severe COVID-19 and/or hospitalization. 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

Bamlanivimab/etesevimab was shown to lower incidence of Covid-19-related hospitalization and death in high-risk ambulatory patients in a clinical trial.

Clinical trial data have not shown a benefit with bamlanivimab/etesevimab use in patients hospitalized patients or 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 September 16, 2021, the FDA revised the EUA for bamlanivimab/etesevimab to include post-exposure prophylaxis (PDF) 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 bamlanivimab/etesevimab as a post-exposure prophylaxis is not a replacement for COVID-19 vaccination. The product should not be used as a pre-exposure prophylaxis.

Resumed Distribution of Bamlanivimab/Etesevimab

As of September 2, 2021, bamlanivimab/etesevimab is effective against variants circulating in California, and is authorized (PDF) for use in California by the FDA.

Distribution of bamlanivimab/etesevimab was paused in California on May 26, 2021 to September 2, 2021, because it had decreased effectiveness against variants that were circulating at that time (specifically, Gamma [P.1] and Beta [B.1.351]).

Distribution of bamlanivimab/etesevimab resumed in the state on September 2, 2021 as the Delta (B.1.617.2) variant became predominant in California.

The vast majority of Delta variant lineages are sensitive to bamlanivimab/etesevimab. The combination of the L452R and T478K substitutions found in most Delta variants results in no change in the susceptibility to the combination of bamlanivimab and etesevimab, as noted in the FDA Fact Sheet for Health Care Providers (PDF). Delta sublineages AY.1 and AY.2 (which include the mutation K417N) are resistant to bamlanivimab/etesevimab. Currently these resistant sublineages make up a very small proportion of circulating virus in the United States and in California.

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 EUA (PDF), which includes this data as well as the full conditions of use, should be reviewed prior to administration of the medication. 

Additional 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).
  • Bamlanivimab/etesevimab can be administered intravenously.
  • Bamlanivimab/etesevimab 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.
  • Bamlanivimab/etesevimab 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 intravenous infusion. There is the potential for serious hypersensitivity reactions, including anaphylaxis, with bamlanivimab/etesevimab 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 bamlanivimab/etesevimab.
  • 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 bamlanivimab/etesevimab.

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 (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 Bamlanivimab/Etesevimab 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.

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 March 9, 2021