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?

The dosage for post-exposure prophylaxis in adults 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.

US_cFAQ_BAM_ETE010A_DOSE_CRITERIA_FOR_USE_PREVENTION_COVID-19
US_cFAQ_BAM_ETE010A_DOSE_CRITERIA_FOR_USE_PREVENTION_COVID-19
en-US

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 For Post-Exposure 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

Criteria for High Risk

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 

Contraindications

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

Dose for Post-exposure 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

The recommended dosing regimen for pediatric patients ≤12 kg is predicted based on pharmacokinetic modeling and simulation. The youngest participant in the pediatric clinical trial for treatment was 10 months of age and weighed 8.6 kg. Children were not enrolled in the post-exposure prophylaxis trial, BLAZE-2.1 

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

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

Rationale for Authorized Dose

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 sex, race, renal or mild hepatic impairment, during pregnancy or while lactating, or in geriatric patients.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 of bamlanivimab and etesevimab for post-exposure prophylaxis due to exposure at different time points, as this has not been evaluated.1

Relevant Pharmacokinetic Information

A summary of pharmacokinetic parameters of bamlanivimab and etesevimab following administration of a single dose of 700 mg bamlanivimab and 1400 mg etesevimab is provided in Pharmacokinetic Parameters of Bamlanivimab and Etesevimab Administered IV in Adults. 1

Pharmacokinetic Parameters of Bamlanivimab and Etesevimab Administered IV in Adults1

 

N

Bamlanivimab 700 mg

Etesevimab 1400 mg

Systemic Exposure

Geometric Mean (%CV) Cmax, mcg/mL

270

187 (41.7)

422 (41.2)

Geometric Mean (%CV) Cday 29, mcg/mL

BAM=311; ETE=320

25.7 (42.9)

116 (38.1)

Median (5th, 95th percentile) Cweek 8, mcg/mL

1000a

10.1 (3.59, 22.9)

58.3 (26.8, 117)

Geometric Mean (%CV) AUCinf, mcg day/mL

499

2500 (28.0)

10600 (29.9)

Distribution

Geometric Mean (%CV) Vss (L)

BAM=1899; ETE=1498b

6.59 (24.9)

5.78 (24.7)

Elimination

Geometric Mean (%CV) elimination half-life (day)

BAM=1899; ETE=1498b

20.9 (17.3)

32.6 (21.7)

Geometric Mean (%CV) clearance (L/day)

BAM=1899; ETE=1498b

0.274 (31.5)

0.134 (32.5)

 Abbreviations: BAM = bamlanivimab; CV = coefficient of variation; Cmax = maximum concentration; AUCinf = area under the concentration vs time curve from zero to infinity; ETE = etesevimab; IV = intravenous; Vss = steady-state volume of distribution.

aN = number of subjects simulated using the PK model.

bThe number of subjects for Vss, half-life, and clearance are based on a population PK model that included bamlanivimab doses up to 7000 mg and etesevimab doses up to 2800 mg.

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


Contact Lilly

Call Us

If you have immediate questions regarding COVID-19, or to report an Adverse Event or Product Complaint, please call us.

Daily Live Support: 9am to 7pm ET.
After Hours: Call Back Support Available

Or you can

Chat with us

Chat with us

Submit a Request

Visit Us @LillyMedical