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.

Have there been treatment interruptions with bamlanivimab and etesevimab IV infusions?

There have been interruptions of bamlanivimab and etestevimab treatment infusions in the clinical trials, none lasted >2 hours. No efficacy or safety analysis of bamlanivimab and etesevimab in patients who had a treatment interruption has been conducted.

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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    

Bamlanivimab and Etesevimab Together Fact Sheet for Healthcare Providers

Dosage

The dosage for treatment of COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is bamlanivimab 700 mg and etesevimab 1400 mg administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.1

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 

Overdosage

Doses up to 7000 mg of bamlanivimab (10 times the authorized dose of bamlanivimab) or 7000 mg of etesevimab (5 times the authorized dose of etesevimab) have been administered in clinical trials without dose-limiting toxicity.1

Treatment of overdose with bamlanivimab and etesevimab should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with either bamlanivimab or etesevimab.1

Clearance and Half-Life

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

Bamlanivimab and Etesevimab Available Clinical Data

BLAZE-1 Clinical Trial

BLAZE-1 is a phase 2/3 randomized, double-blind, placebo-controlled trial evaluating bamlanivimab alone and together with etesevimab, in non-hospitalized patients with mild to moderate COVID-19.3,4

An estimated 3160 patients will be randomized to the following treatment arms in the BLAZE-1 study:

  • bamlanivimab (700 mg, 2800 mg, and 7000 mg) IV infusion
  • bamlanivimab (2800 mg) and etesevimab (2800 mg) together IV infusion
  • bamlanivimab (700 mg) and etesevimab (1400 mg) together IV Infusion, or
  • placebo IV infusion.3,4

Analysis of Treatment Interruptions

During the BLAZE-1 study, there were no treatment interruptions of bamlanivimab and etesevimab together that were greater than 2 hours.5

In the majority of treatment interruptions due to technical reasons, bamlanivimab and etesevimab treatment was resumed and completed.5

An analysis of the efficacy and safety of bamlanivimab and etesevimab in patients who had a treatment interruption during the bamlanivimab and etesevimab IV infusion has not been conducted.

Incidence of Overdose

In BLAZE-1, across both the Phase 2 and Phase 3 data, there were no reports of an overdose of bamlanivimab and etesevimab delivered together at a dose higher than the assigned treatment arm dose.5

References

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

3Gottlieb 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

4A study of LY3819253 (LY-CoV555) and LY3832479 (LY-CoV016) in participants with mild to moderate COVID-19 illness (BLAZE-1). ClinicalTrials.gov identifier: NCT04427501. Updated September 8, 2021. Accessed September 14, 2021. https://www.clinicaltrials.gov/ct2/show/NCT04427501

5Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

COVID-19 = coronavirus disease 2019

CV = coefficient of variance

EUA = emergency use authorization

FDA = Food and Drug Administration

IV = intravenous

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

Date of Last Review: September 21, 2021


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