Skip Navigation LinksBamlanivimab-Fact-Sheet

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EDMUND G. BROWN JR.
Governor

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


December 31, 2020


TO:
All Californians

SUBJECT:
California Department of Public Health Bamlanivimab Distribution Fact Sheet


Bamlanivimab is an investigational monoclonal antibody that has been engineered to bind to and neutralize SARS-CoV-2 and prevent progression to severe illness. Clinical trial data in outpatients have shown that bamlanivimab use may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for severe disease. Clinical trial data in hospitalized patients, however, have not shown a benefit with bamlanivimab use, and it is not authorized for use in patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.

Additional clinical trial data:

  • BLAZE-1 clinical trial (465 non-hospitalized adults at high risk for disease progression): The primary study outcome was the change from baseline in viral load by day 11 and the decline in viral load was not significantly improved with bamlanivimab treatment. A secondary analysis demonstrated that hospitalizations and emergency room visits occurred in 1.6% of bamlanivimab-treated patients compared to 6.3% in placebo-treated patients.[1]  In the subset of patients who were > 65 years of age or with a body mass index (BMI) > 35, hospitalizations and emergency room visits occurred in 4.2% of bamlanivimab-treated patients compared to 14.6% in placebo-treated patients.
  • ACTIV-3 clinical trial (326 participants in the bamlanivimab protocol) designed to test the safety and efficacy of various investigational agents, including bamlanivimab, for the treatment of hospitalized patients with COVID-19. The use of bamlanivimab was discontinued in this trial based on data suggesting that bamlanivimab was not beneficial in hospitalized COVID-19 patients.[2]

The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) on November 9, 2020 for the use of bamlanivimab for the treatment of mild to moderate COVID-19. The fact sheet for health care providers [3] reviews the full conditions of use, and should be reviewed prior to administration of the medication.

The EUA allows outpatient treatment of mild to moderate COVID-19 in adult and pediatric (> 12 years of age and weight > 40 kg) patients with mild to moderate COVID-19 in adults and pediatric patients with a positive SARS-CoV-2 viral test and who are high risk for severe illness. EUA conditions 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 and within 3 days of specimen collection, consistent with the clinical trial, as early treatment is expected to have the most benefit.
  • High risk is defined as at least one of the following conditions: BMI ≥ 35, chronic kidney disease, diabetes, immunosuppression (from disease or treatment), or age ≥ 65 years. Additional high risk criteria are defined for people ≥ 55 years of age and for people 12 – 17 years of age. Notably, pediatric patients were not included in the clinical trial and CDPH does not recommend pediatric treatment at this time.
  • Bamlanivimab is not authorized for use in patients who are hospitalized with COVID-19 or who require oxygen therapy due to COVID-19. Treatment is also not authorized for asymptomatic patients. Bamlanivimab is indicated for patients with mild or moderate symptoms, including fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.
  • Bamlanivimab is administered by intravenous (IV) infusion over 60 minutes and 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 the IV infusion and observed for at least 60 minutes after infusion. There is the potential for serious hypersensitivity reactions, including anaphylaxis, with bamlanivimab administration (see full EUA prescribing information in the fact sheet for health care providers [3]). Infusion-related reactions (pruritus, flushing, rash, or facial swelling) were reported in 2.3% of patients who received bamlanivimab. These reactions were reported to be mild and all patients completed their infusions.
  • 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. 
  • Health care providers must communicate information consistent with the "Fact Sheet for Patients, Parents and Caregivers"[4] (and provide a copy) prior to the patient receiving bamlanivimab.

Allocation of bamlanivimab for EUA use
Updated since version published on November 13, 2020

Allocations are made from the federal government to the state of California every two weeks. Bamlanivimab allocation was rolled out in two phases. In phase 1, bamlanivimab was allocated to hospitals and hospital-affiliated locations only. Now in phase 2, bamlanivimab is being allocated to additional outpatient facilities. In phase 2, the state is allocating bamlanivimab directly to skilled nursing facilities (SNFs), PACE programs and correctional facilities. The remaining supply of bamlanivimab is proportionately distributed to the counties' Medical and Health Operational Area Coordinator (MHOAC) per the established Multi-Agency Coordination Group (MAC Group) process. The proportional allocation formula includes the 7-day average of new COVID-19 admissions and conversions (75% weight) and the 7-day average of new COVID-19 cases (25% weight) in the county. The MHOAC will allocate bamlanivimab within their county to outpatient facilities and hospitals. Based on this allocation bamlanivimab will be shipped to hospitals by AmerisourceBergen. There is no charge to counties, hospitals, or patients for bamlanivimab but there are infusion costs to administer the medication. For more details regarding California's allocation and distribution strategy for monoclonal antibodies, please visit the Allocation and Distribution Strategy for Monoclonal Antibodies Fact Sheet web page. California currently has a sufficient supply of bamlanivimab for all providers who request it. However, if demand were to exceed supply in the future, hospitals should consider an ethical framework for the distribution of bamlanivimab to outpatients, and refer to the California SARS-CoV-2 Crisis Care Guidelines and California Guidance for Hospitals Regarding Allocation of Scarce Medications for COVID-19.

[1]  Chen P, Nirula A, Heller B, et al. SARS-CoV-2 Neutralizing Antibody LY-CoV555 in Outpatients with Covid-19. NEJM. Electronically published: October 28, 2020. DOI: 10.1056/NEJMoa2029849

[2]  NIH Press Release. Statement—NIH-Sponsored ACTIV-3 Trial Closes LY-CoV555 Sub-Study. October 26, 2020

[3]  Fact Sheet for Healthcare Providers – Emergency Use Authorization (EUA) of Bamlanivimab

[4]  Fact Sheet for Patients, Parents and Caregivers - Emergency Use Authorization (EUA) of Bamlanivimab for Coronavirus Disease 2019 (COVID-19)

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