bamlanivimab and etesevimab together

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What are the pharmacokinetic and pharmacodynamic characteristics of bamlanivimab and etesevimab together in pediatric patients?

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.

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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

The pharmacokinetics of bamlanivimab and etesevimab has been evaluated in 88 pediatric patients <18 years who received weight-based dosing (see Pharmacokinetic Parameters of Bamlanivimab and Etesevimab Administered IV in Pediatric Patients). 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

Pharmacokinetic Parameters of Bamlanivimab and Etesevimab Administered IV in Pediatric Patients1

Body Weight

≥40 kg

>20 to <40 kg

>12 to ≤20 kg

≤12 kg

BAM/ETE Dose

700 mg/1400 mg

350 mg/700 mg

175 mg/350 mg

15 mg/kg / 30 mg/kg

Bamlanivimab: Geometric Mean (%CV) [n]

Cmax, mcg/mL

235 (51.0) [52]

239 (39.1) [16]

243 (66.0) [7]

371 (9.8) [2]

Cday 29, mcg/mL

26.8 (50.2) [34]

26.1 (32.5) [8]

23.0 (53.0) [3]

[0]

AUCinf, mcg day/mL

2760 (30.7) [66]

2780 (25.7) [20]

2430 (28.4) [9]

3000 (19.1) [3]

Etesevimab: Geometric Mean (%CV) [n]

Cmax, mcg/mL

508 (50.6) [50]

444 (26.6) [14]

444 (64.9) [7]

831 (16.8) [2]

Cday 29, mcg/mL

133 (46.8) [34]

138 (29.5) [8]

125 (51.5) [3] 

[0]

AUCinf, mcg day/mL

12900 (32.4) [66]

12400 (23.2) [20]

11300 (29.6) [9]

13500 (13.0) [3]

 Abbreviations: CV = coefficient of variation; Cmax = maximum concentration; AUCinf = area under the concentration vs time curve from zero to infinity.

Bamlanivimab and Etesevimab Available Clinical Data

Concentrations of Bamlanvimab and Etesevimab for Weight Based Dosing

Individual concentration-time profiles for pediatric patients who received weight-based dosing are shown in Pediatric Serum Concentration Profiles by Weight Category Matched Adult Concentration Profiles Administered Bamlanivimab 700 mg. Pediatric weight-based dosing resulted in comparable concentration-time profiles as has been observed in adults who received bamlanivimab 700 mg and etesevimab 1400 mg together.3

Pediatric Serum Concentration Profiles by Weight Category Matched Adult Concentration Profiles Administered Bamlanivimab 700 mg3

Figure 1 description: Pediatric weight-based dosing resulted in comparable concentration-time profiles as has been observed in adults who received bamlanivimab 700 mg and etesevimab 1400 mg together.

Abbreviations: BAM = bamlanivimab; ETE = etesevimab.

Note: Blue shading represents 90% prediction interval of modeling of bamlanivimab 700 mg in adults. Circles represent individual pediatric data.

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 December 22, 2021. Accessed December 22, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

3Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: December 23, 2021


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