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, 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 Together Fact Sheet for Healthcare Providers

Dosage

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

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.1 

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

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 

Overdosage

Doses up to 7000 mg of bamlanivimab (10 times the authorized dose of bamlanivimab for adults [≥18 years] and pediatric patients [<18 years weighing at least 40 kg]) or 7000 mg of etesevimab (5 times the authorized dose of etesevimab for adults [≥18 years] and pediatric patients [<18 years weighing at least 40 kg]) 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

Pharmacokinetics

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. There is no change in the PK of bamlanivimab or etesevimab administered alone or together suggesting there is no interaction between the two antibodies. There were no differences in PK of etesevimab between mild/moderate ambulatory participants and healthy participants.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.

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-19.3-5

Patients were 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.3-5

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.6

In the majority of treatment interruptions due to technical reasons, bamlanivimab and etesevimab treatment was resumed and completed.6

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.6

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 December 22, 2021. Accessed December 22, 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

4Dougan M, Azizad M, Mocherla B, et al. A randomized, placebo-controlled clinical trial of bamlanivimab and etesevimab together in high-risk ambulatory patients with COVID-19 and validation of the prognostic value of persistently high viral load. Clin Infect Dis. Published online October 28, 2021. http://dx.doi.org/10.1093/cid/ciab912

5Dougan M, Nirula A, Azizad M, et al. Bamlanivimab plus etesevimab in mild or moderate covid-19. N Eng J Med. Published online July 14, 2021. http://dx.doi.org/10.1056/NEJMoa2102685

6Data 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: December 23, 2021


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