bamlanivimab and etesevimab together

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What are the criteria for use and recommended dose of bamlanivimab and etesevimab together for the treatment of COVID-19?

The recommended dose is bamlanivimab 700 mg and etesevimab 1400 mg given together as a single IV infusion and administered as soon as possible after testing positive for SARS-CoV-2 and within 10 days of symptom onset.

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Bamlanivimab and Etesevimab Emergency Use Authorization

Bamlanivimab and etesevimab have not been approved, but have only been authorized for emergency use by FDA to be administered together for the treatment of 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 progression to severe COVID-19, including hospitalization or death.1,2

Bamlanivimab and etesevimab are authorized to be administered together for the treatment of 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 progression to severe COVID-19, including hospitalization or death only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the bamlanivimab and etesevimab under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.1,2

For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com.

Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%, as determined by FDA. A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website: https://www.fda.gov/media/151719/download .1,2

Limitations of Authorized Use

Combined Frequency of Variants Resistant to Bamlanivimab and Etesevimab

Bamlanivimab and etesevimab are not authorized for use in states, territories, and US jurisdictions in which the combined frequency of variants resistant to bamlanivimab and etesevimab exceeds 5%. A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized is available on the following FDA website: https://www.fda.gov/media/151719/download .1

FDA will make this determination considering

FDA will update the list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are and are not currently authorized as new data and information becomes available. Healthcare providers should refer to the FDA website regularly for updates.1 

Use in Patients Who Are Hospitalized or Who Require Oxygen Due to COVID-19

Bamlanivimab and etesevimab are not authorized for use in patients:

  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.1

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.1

Bamlanivimab and Etesevimab Fact Sheet for Healthcare Providers

Contraindications

There are no known contraindications for bamlanivimab and etesevimab together.1

Bamlanivimab and Etesevimab Dosing

Patient Selection and Treatment Initiation

Bamlanivimab and etesevimab should be administered together as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset in adults and pediatric patients (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.1

The following medical conditions or other factors may place adults and pediatric patients (12 years of age and older weighing at least 40 kg) at higher risk for progression to severe COVID-19:

  • Older age (for example age ≥65 years of age)
  • Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if age 12-17, have BMI ≥85th percentile for their age and gender based on CDC growth charts3
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Cardiovascular disease (including congenital heart disease) or hypertension
  • Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension)
  • Sickle cell disease
  • Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
  • Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID 19])1

Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of bamlanivimab and etesevimab under the EUA is not limited to the conditions listed above.1

For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the CDC website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html . Healthcare providers should consider the benefit-risk for an individual patient.1

Recommended Dosage

The dosage of bamlanivimab and etesevimab for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is

  • bamlanivimab 700 mg, and
  • etesevimab 1400mg.1 

Administer bamlanivimab and etesevimab as soon as possible after positive viral test for SARS-CoV-2 and within 10 days of symptom onset.1

Bamlanivimab and etesevimab must be diluted and administered together as a single intravenous infusion.1

Dosage Adjustment in Specific Populations

No dosage adjustment is recommended based on age, sex, race, body weight, renal or mild hepatic impairment, during pregnancy or while lactating, or for disease severity or inflammation.

  • Based on population PK analysis, there is no difference in PK of bamlanivimab and etesevimab in patients with mild hepatic impairment compared to patients with normal hepatic function.1
  • Bamlanivimab and etesevimab have not been studied in patients with moderate or severe hepatic impairment.1

Bamlanivimab and Etesevimab Available Clinical Data

BLAZE-1 SARS-CoV-2 Permitted Testing

Any type of direct SARS-CoV-2 testing was permitted in the BLAZE-1 clinical trial, provided it was an FDA-approved test to allow for maximum flexibility at clinical trial sites.4

Direct SARS-CoV-2 Viral Testing

Viral testing determines COVID-19 infection by detecting SARS-CoV-2 nucleic acid or antigen from the respiratory system (such as nasal or oral swabs or saliva) or blood. Therefore, viral tests directly test acute infection.5

SARS-CoV-2 Antibody Testing

The FDA has not authorized using antibody tests to diagnose SARS-CoV-2 infection, the virus that causes COVID-19. Antibody tests do not directly test for acute viral infection. Antibody tests can help determine whether the individual being tested was previously infected.5

Healthcare Setting for Patient Selection and Treatment Initiation

Bamlanivimab and etesevimab are not authorized for use in patients who are hospitalized due to COVID-19.1

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.1

However, if patient selection criteria are met for a patient who is hospitalized, but not due to COVID-19, bamlanivimab and etesevimab may be considered. 

Bamlanivimab and 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, and the ability to activate the emergency medical system (EMS), as necessary.1

BLAZE-1 Patient Monitoring

During the BLAZE-1 clinical trial, patients were monitored during the infusion as well as for at least 2 hours after completion of the infusion.4

Immediately prior to the infusion and 30 minutes after completion of the infusion, the following vital signs were assessed

  • body temperature
  • pulse rate
  • blood pressure
  • respiratory rate
  • SpO2 at rest, and
  • supplemental oxygen flow rate, FiO2 if known, and method of delivery, if applicable. 4

During the infusion, only record pulse rate, BP and SpO2.4

Automation was permitted to be used to measure vital signs.4

References

The published reference below is available by contacting 1-800-LillyRx (1-800-545-5979).

1Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2021.

2United States Food and Drug Administration. Bamlanivimab and Etesevimab FDA Emergency Use Authorization Letter. Issued August 27, 2021. Accessed August 27, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

3Centers for Disease Control and Prevention. Clinical growth charts. Updated June 16, 2017. Accessed August 11, 2021. https://www.cdc.gov/growthcharts/clinical_charts.htm

4Gottlieb RL, Nirula A, Chen P, et al. Effect of bamlanivimab as monotherapy or in combination with etesevimab on viral load in patients with mild to moderate COVID-19: a randomized clinical trial. JAMA. 2021;325(7):632-644. http://dx.doi.org/10.1001/jama.2021.0202

5Overview of Testing for SARS-CoV-2 (COVID-19). Center for Disease Control and Prevention website. https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html. Published October 21, 2020. Accessed November 18, 2020.

Glossary

ASPR = Assistant Secretary for Preparedness and Response

BAM = bamlanivimab

BMI = body mass index

CDC = Centers for Disease Control and Prevention

COVID-19 = coronavirus disease 2019

ETE = etesevimab

EUA = emergency use authorization

FDA = Food and Drug Administration

IV = intravenous

Lilly = Eli Lilly and Company

SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2

SpO2 = peripheral capillary oxygen saturation

US = United States

Date of Last Review: June 25, 2021


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