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 dose of bamlanivimab and etesevimab for post-exposure prophylaxis of COVID-19?

For post-exposure prophylaxis, a single IV infusion of bamlanivimab 700 mg and etesevimab 1400 mg together should be administered as soon as possible following exposure to SARS-CoV-2.

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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 (12 years of age and older weighing at least 40 kg) 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 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

  • 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%.1
    • The Food and Drug Administration (FDA) will make this determination considering
    • The 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
    • A list of states, territories, and US jurisdictions in which bamlanivimab and etesevimab are currently authorized is available on the following Food and Drug Administration (FDA) website: https://www.fda.gov/media/151719/download
  • 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

Bamlanivimab and Etesevimab Fact Sheet for Healthcare Providers

Contraindications

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

Patient Selection for Post-exposure Prophylaxis

This section provides essential information on the unapproved products bamlanivimab and etesevimab administered together 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 for:

  • Postexposure prophylaxis of COVID-19 in high risk individuals who 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 (for example, nursing homes and prisons).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). See this Centers for Disease Control and Prevention website for more details.1,3

For more information on immunocompromising conditions and immunosuppressive medications, see this Centers for Disease Control and Prevention website.4

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 Centers for Disease Control and Prevention website for additional details.5

Criteria for Identifying High Risk Individuals

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 charts, https://www.cdc.gov/growthcharts/clinical_charts.htm)
  • 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 Emergency Use Authorization (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 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 Dose for Prevention

The dosage for postexposure prophylaxis in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 700 mg bamlanivimab and 1400 mg etesevimab administered together as soon as possible following exposure to SARS-CoV-2.1

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

Rationale for Authorization for Post-exposure Prophylaxis

The authorized dosage is 700 mg bamlanivimab and 1400 mg of etesevimab administered together as a single intravenous (IV) infusion as soon as possible after exposure to SARS-CoV-2.1

The authorized dosage is based on the totality of the scientific evidence including clinical pharmacology data and clinical trial data.1

The clinical data for postexposure prophylaxis is based on data generated in the phase 3 study BLAZE-2. While this study only evaluated dosing with bamlanivimab alone, it is reasonable to expect that bamlanivimab and etesevimab together may be safe and effective for postexposure prophylaxis based on the following.1

  • Phase 3 data from BLAZE-1 demonstrated treatment of COVID-19 with bamlanivimab and etesevimab together showed a statistically significant reduction in progression of severe COVID-19, including hospitalization or death.
  • Nonclinical and clinical data support that bamlanivimab and etesevimab together will provide an advantage over bamlanivimab alone against certain SARS-CoV-2 viral variants.

Use of bamlanivimab and etesevimab together for postexposure prophylaxis in subjects who meet high-risk criteria is based on a subgroup analysis of high-risk individuals enrolled in BLAZE-2.1

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.1

Based on population pharmacokinetic analysis, there is no difference in the pharmacokinetics of bamlanivimab or 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

Clinical Trial Information

Repeat Dosing

No clinical or pharmacokinetic data are available for repeat dosing for post-exposure prophylaxis due to exposure at different time points, as this has not been studied.

Relevant Pharmacokinetic Information

Bamlanivimab clearance (CL) was 0.27 L/day (between subject variability 22.3% CV) and the mean apparent terminal elimination half-life was 17.6 days (between subject variability 15.8% CV). Following a single 700-mg IV dose, bamlanivimab was quantifiable for at least 29 days. The mean concentration was 22 µg/mL (90% CI: 10.7 to 41.6 µg/mL) on day 29.1

Etesevimab clearance (CL) was 0.128 L/day (between subject variability 33.8% CV) and the mean apparent terminal elimination half-life was 25.1 days (between subject variability 29.2% CV). Following a single 1400-mg IV dose, etesevimab was quantifiable for at least 29 days. The mean concentration was 111 µg/mL (90% CI: 57.4 to 199 µg/mL) on day 29.1

References

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 September 16, 2021. Accessed September 16, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

3Centers for Disease Control and Prevention. When you've been fully vaccinated. Updated July 27, 2021. Accessed August 11, 2021. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated

4Centers for Disease Control and Prevention. Science brief: COVID-19 vaccines and vaccination. Updated July 27, 2021. Accessed September 13, 2021. https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html

5Centers for Disease Control and Prevention. Quarantine and isolation. Updated July 29, 2021. Accessed August 11, 2021. https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html

Date of Last Review: October 06, 2021


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