bamlanivimab and etesevimab together

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How do you prepare the IV infusion of bamlanivimab and etesevimab together?

Bamlanivimab and etesevimab together solution for infusion should be prepared by a qualified healthcare professional using aseptic technique.

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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 FDA to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.1,2

Bamlanivimab and etesevimab are authorized to be administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death only 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) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.1,2

For information on the authorized use of bamlanivimab and etesevimab together and mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com.

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 Fact Sheet for Healthcare Providers

Bamlanivimab and Etesevimab IV Infusion Preparation

Bamlanivimab and etesevimab solution for infusion should be prepared by a qualified healthcare professional using aseptic technique:

  • Gather the materials for preparation: 
    • Polyvinyl chloride (PVC) or polyethylene (PE)-line PVC, sterile prefilled infusion bag. Choose one of the following sizes:  
      • Prefilled 50 mL, 100 mL, 150 mL, or 250 mL infusion bag containing 0.9% Sodium Chloride Injection 
    • One vial of bamlanivimab (700mg/20mL) and two vials of etesevimab (700mg/ 20mL). 
  • Bamlanivimab and etesevimab are supplied in individual single-dose vials but are administered together using a single infusion bag.
  • Remove 1 bamlanivimab and 2 etesevimab vials from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. Do not expose to direct heat. Do not shake the vials.
  • Inspect both bamlanivimab and etesevimab vials visually for particulate matter and discoloration.
    • Bamlanivimab and etesevimab are clear to opalescent and colourless to slightly yellow to slightly brown solutions.
  • Withdraw 20 mL from one bamlanivimab vial and 40 mL from two etesevimab vials and inject all 60 mL into a prefilled infusion bag containing 0.9% Sodium Chloride (see Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusion in Patients Weighing Less Than 50 kg or Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusion in Patients Weighing 50 kg or More ). 
  • Discard any product remaining in the vials.
  • Gently invert the bag by hand approximately 10 times to mix. Do not shake.
  • These products are preservative-free and therefore, the diluted infusion solution should be administered immediately.
    • If immediate administration is not possible, store the diluted infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) and up to 7 hours at room temperature (20°C to 25°C [68°F to 77°F]) including infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 20 minutes prior to administration.1
Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusiona in Patients Weighing 50 kg or More 1


Druga: Add 20 mL bamlanivimab (1 vial) and 40 mL of etesevimab (2 vials) for a total of 60 mL to a prefilled infusion bag and administer as instructed below

Size of Prefilled 0.9% Sodium Chloride Infusion Bag

Maximum infusion rate

Minimum infusion Time 

50 mL

310 mL/hr

21 minutes

100 mL

310 mL/hr 

31 minutes

150 mL

310 mL/hr

41 minutes

250 mL

310 mL/hr

60 minutes

Abbreviations: BAM = bamlanivimab; ETE = etesevimab; IV = intravenous 

a700 mg of bamlanivimab and 1400 mg of etesevimab are added to the same infusion bag and administered together as a single intravenous infusion

Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusiona in Patients Weighing Less Than 50 kg1


Druga: Add 20 mL bamlanivimab (1 vial) and 40 mL of etesevimab (2 vials) for a total of 60 mL to a prefilled infusion bag and administer as instructed below

Size of Prefilled 0.9% Sodium Chloride Infusion Bag

Maximum infusion rate

Minimum infusion Time 

50 mL

310 mL/hr

21 minutes

100 mL

310 mL/hr 

31 minutes

150 mL

310 mL/hr

41 minutes

250 mLb

266 mL/hr

70 minutes

Abbreviations: BAM = bamlanivimab; ETE = etesevimab; IV = intravenous 

a700 mg of bamlanivimab and 1400 mg of etesevimab are added to the same infusion bag and administered together as a single intravenous infusion

bThe minimum infusion time for patients weighing less than 50 kg who are administered bamlanivimab and etesevimab using the 250 mL prefilled 0.9% Sodium Chloride infusion bag must be extended to at least 70 minutes to ensure safe use (endotoxin load).

Bamlanivimab and Etesevimab Additional Clinical Data

Additional Aseptic Technique Information

Lilly does not provide an aseptic technique directive for the preparation of the bamlanivimab and etesevimab solution for infusion. The procedure followed for aseptic technique may vary between institutions. Healthcare professionals must follow aseptic technique directive provided by their institution for preparation of intravenous infusion, to prepare the dosing solution for infusion.3

Bamlanivimab and etesevimab together contain no preservative. The bamlanivimab and etesevimab solution for infusion should be prepared by a qualified healthcare professional using aseptic technique to prevent contamination from pathogens.3

Bamlanivimab and etesevimab are neither hazardous nor toxic when spilled. 

The bamlanivimab and etesevimab together Fact Sheet for Healthcare Providers does not stipulate that a laminar flow cabinet, hood, or a negative air pressure room must be used to prepare the infusion solution.1,3

Various Infusion Bag Sizes

Lilly conducted assessments to determine if the volume of 20 mL of bamlanivimab and 40 mL of etesevimab could be added into a 50 mL, 100 mL, or 250 mL IV bags of  0.9% Sodium Chloride, considering the nominal overfill volumes in the bags (see Vendor-Provided Fill Volume Range and Experimentally Measured Fill Volumes for Intravenous Bags of 0.9% Sodium Chloride Injection Manufactured by United States and Japan Sources). 3

Vendor-Provided Fill Volume Range and Experimentally Measured Fill Volumes for Intravenous Bags of 0.9% Sodium Chloride Injection Manufactured by United States and Japan Sources3

Vendor

Bag Size

Vendor-Provided Volume Range in Pre-filled Bags

Actual Measured Volume in Pre-filled Bags

(Average of n = 3)

B. Braun

50 mL

53 - 61 mLa

NAb

100 mL

105 - 113 mLa

109 mL

250 mL

263 - 276 mLc

273 mL

Baxter

250 mL

265 - 285 mLd

273 mL

ICU Medical

100 mL

103 - 113 mLe

107 mL

250 mL

260 - 300 mLe

270 mL

Terumo (Japan)

100 mL

NA

102 mL

250 mL

NA

260 mL

Abbreviations: NA = not available.

ahttps://www.bbraunusa.com/content/dam/catalog/bbraun/bbraunProductCatalog/S/AEM2015/en-us/b/pab-faqs.pdf

bNot measured due to unavailability of bags

chttps://www.bbraunusa.com/content/dam/catalog/bbraun/bbraunProductCatalog/S/AEM2015/en-us/b/excel-faqs0.pdf

dhttps://ecatalog.baxter.com/ecatalog/loadResource.blob?bid=58139

eICU Medical letter, reference number US2021-00052

An additional 60 mL of 0.9% Sodium Chloride solution was added into each of the respective prefilled bag sizes of 0.9% Sodium Chloride listed in Vendor-Provided Fill Volume Range and Experimentally Measured Fill Volumes for Intravenous Bags of 0.9% Sodium Chloride Injection Manufactured by United States and Japan Sources. Because the bags are flexible in nature, all sizes were capable of accommodating 60 mL of additional solution, while providing adequate space to enable mixing of the bag contents. These data are consistent with the physical findings for the Baxter bags as well.3

Therefore, given that the volume of bamlanivimab (20 mL) and etesevimab (40 mL) added to the prefilled bag totals 60 mL, there is enough space to allow for mixing without first withdrawing normal saline from the prefilled bag, over the range of 50 mL to 250 mL prefilled bag sizes.3

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 August 27, 2021. Accessed August 27, 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.

Glossary

ASPR = Assistant Secretary for Preparedness and Response

BAM = bamlanivimab

CDC = Centers for Disease Control and Prevention

COVID-19 = coronavirus disease 2019

ETE = etesevimab

EUA = emergency use authorization

FDA = Food and Drug Administration

IV = intravenous

Lilly = Eli Lilly and Company

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

US = United States

Date of Last Review: June 25, 2021


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