bamlanivimab and etesevimab together

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.

What are the criteria for use and recommended dose of bamlanivimab and etesevimab together in pediatric patients with COVID-19?

The dosage in pediatric patients (<18 years and weighing at least 40 kg) is bamlanivimab 700 mg and etesevimab 1400 mg. The dosage for pediatric patients weighing less than 40 kg will vary depending on body weight.

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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 Food and Drug Administration (FDA) 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)(C) of the Act, 21 U.S.C. 360bbb-3, unless the authorization is terminated or revoked sooner.1,2   

Bamlanivimab and etesevimab are authorized to be administered together in adults and pediatric patients, including neonates, who are at high risk for progression to severe coronavirus disease 2019 (COVID-19), including hospitalization or death for

  • the treatment of mild to moderate COVID-19, or
  • post-exposure prophylaxis of COVID-19.1,2    

For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com. 1,2    

Bamlanivimab and Etesevimab Fact Sheet for Healthcare Providers

Authorized Use

Treatment

Bamlanivimab and etesevimab administered together are authorized for use under an Emergency Use Authorization (EUA) for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, 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

Limitations of Authorized Use

Combined Frequency of Variants Resistant to Bamlanivimab and Etesevimab

Bamlanivimab and etesevimab are not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency.1

FDA’s determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.1

FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility and CDC regional variant frequency data available at:  https://covid.cdc.gov/covid-data-tracker/#variant-proportions.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 2 years and older who are hospitalized due to COVID-19.1

The reasons for hospital admission may be different and the threshold for hospital admission may be lower for neonates, young infants and toddlers with COVID-19 compared to older children and adults. The authorization allows for young children (i.e., birth to 2 years of age) who are hospitalized with mild to moderate COVID-19 at the time of treatment to receive bamlanivimab and etesevimab.1

Bamlanivimab and etesevimab are not authorized for use in patients, regardless of age who require

  • oxygen therapy and/or respiratory support due to COVID-19, OR
  • an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support 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

Postexposure Prophylaxis

Bamlanivimab and etesevimab administered together are authorized for use under an EUA for postexposure prophylaxis of COVID-19 in adults and pediatric individuals, including neonates, who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

  • not fully vaccinated or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications) and
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) or
    • who 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, such as nursing homes, prisons, or schools.1 

Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series (such as the Pfizer or Moderna vaccines), or 2 weeks after a single-dose vaccine (such as Johnson & Johnson’s Janssen vaccine).1 See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated.

For more information on immunocompromising conditions and immunosuppressive medications, see https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.

Close contact with an infected individual is defined as

  • being within 6 feet for a total of 15 minutes or more
  • providing care at home to someone who is sick
  • having direct physical contact with the person (hugging or kissing, for example)
  • sharing eating or drinking utensils, or
  • being exposed to respiratory droplets from an infected person (sneezing or coughing, for example).1 

See this website for additional details: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html.

Limitations of Authorized Use

Bamlanivimab and etesevimab are not authorized for post-exposure prophylaxis of COVID-19 in geographic regions where exposure is likely to have been to a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency. 1

FDA’s determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.1

FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility and CDC regional variant frequency data available at:  https://covid.cdc.gov/covid-data-tracker/#variant-proportions.1

Postexposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19.1

Bamlanivimab and etesevimab together are not authorized for pre-exposure prophylaxis for prevention of COVID-19.1

Contraindications

There are no contraindications listed in the bamlanivimab and etesevimab Emergency Use Authorization (EUA) prescribing information.1

Bamlanivimab and Etesevimab Dosing

Patient Selection 

The following medical conditions or other factors may place adults and pediatric patients, including neonates, at higher risk for progression to severe COVID-19:1 

  • Older age (for example age ≥65 years of age)
  • <1 year old
  • Obesity or being overweight
  • 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])

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 medical conditions or factors listed above. For additional information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (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

Under this EUA, bamlanivimab and etesevimab must be administered together as a single intravenous infusion.1 

The pharmacokinetics of bamlanivimab and etesevimab has been evaluated in 88 pediatric patients <18 years who received weight-based dosing. The data show that weight-based dosing in pediatric patients provides comparable plasma exposures to those observed in adults who received bamlanivimab 700 mg and etesevimab 1400 mg.1 

No dosage adjustment is recommended in pediatric patients <18 years who weigh at least 40 kg. Pediatric patients weighing less than 40 kg should be dosed on the basis of body weight.1 

The recommended dosing regimen for pediatric patients ≤12 kg is predicted to result in similar exposures when compared to exposures achieved in adults receiving bamlanivimab 700 mg and etesevimab 1400 mg based on pharmacokinetic modeling and simulation. The youngest participant in the pediatric treatment trial was 10 months of age and weighed 8.6 kg.1

Treatment

The dosage for treatment of COVID-19 in adults (18 years and older) and pediatric patients (<18 years and weighing at least 40 kg) is 700-mg bamlanivimab and 1400-mg etesevimab.1

The dosage for pediatric patients weighing less than 40 kg will vary depending on body weight

  • >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
  • >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
  • 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab1

For treatment of COVID-19, bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.1

Postexposure Prophylaxis

The dosage for post-exposure prophylaxis in adults (18 years and older) and pediatric individuals (<18 years and weighing at least 40 kg) is 700-mg bamlanivimab and 1400-mg etesevimab administered together as a single IV infusion.1

The dosage for pediatric individuals weighing less than 40 kg will vary depending on body weight

  • >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
  • >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
  • 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab1

For post-exposure prophylaxis, bamlanivimab and etesevimab should be given together as soon as possible following exposure to SARS-CoV-2.1 

References

1Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2022.

2United States Food and Drug Administration. Bamlanivimab and etesevimab FDA Emergency Use Authorization letter. Issued January 24, 2022. Accessed January 25, 2022. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

Date of Last Review: January 26, 2022


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