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.

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

Bamlanivimab and etesevimab solution for infusion should be prepared by a qualified healthcare professional using an 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 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

Preparation and Administration

General Information

  • Bamlanivimab and etesevimab solution for infusion should be prepared by a qualified healthcare professional using aseptic technique. 
  • Bamlanivimab and etesevimab are supplied in individual vials but are administered together. 
  • Inspect bamlanivimab and etesevimab vials visually for particulate matter and discoloration. Bamlanivimab and etesevimab are clear to opalescent and colorless to slightly yellow to slightly brown solutions. 
  • The prepared infusion solution should not be administered simultaneously with any other medication. The compatibility of bamlanivimab and etesevimab injection with IV solutions and medications other than 0.9% Sodium Chloride Injection is not known. 
  • If the infusion must be discontinued due to an infusion reaction, discard any unused product. 
  • The use of closed system transfer devices (CSTDs), elastomeric pumps, and pneumatic transport with bamlanivimab and etesevimab has not been studied. 
  • Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.

Intravenous Infusion in Adults (≥18 Years Regardless of Weight) and Pediatric Patients (<18 Years and Weighing at Least 40 kg)

Materials Needed

  • 1 bamlanivimab vial (700 mg/20 mL)
  • 2 etesevimab vials (700 mg/20 mL)
  • 1 polyvinyl chloride (PVC) or polyethylene (PE)-lined PVC, sterile prefilled infusion bag containing 0.9% sodium chloride injection (sizes 50-250 mL)
  • 1 PVC or PE-lined PVC infusion set
  • 1 in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter
  • 0.9% sodium chloride for flushing tubing1

Preparation

Administration

  • 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.
  • Attach the infusion set to the IV bag. Use of in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter is strongly recommended.
  • Prime the infusion set.
  • Administer the entire infusion solution in the bag via pump or gravity according to the size of infusion bag used (see Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusion in Adults (≥18 Years Regardless of Weight) and Pediatric Patients (<18 Years and Weighing at Least 40 kg)). Due to potential overfill of prefilled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage.
  • Once infusion is complete, flush the tubing with 0.9% sodium chloride to ensure delivery of the required dose.1
Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusiona in Adults (≥18 Years Regardless of Weight) and Pediatric Patients (<18 Years and Weighing at Least 40 kg)1

Druga: Add 20 mL of 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, mL

Maximum Infusion Rate, mL/h

Minimum Infusion Time, min

50

310

21

100

310

31

150

310

41

250 (for patients weighing at least 50 kg) 

310

60

250b (for patients weighing ≥40 kg and <50 kg)

266

70

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 at least 40 kg and less than 50 kg who are administered bamlanivimab and etesevimab diluted in a 250-mL prefilled 0.9% sodium chloride infusion bag must be extended to at least 70 minutes to reduce endotoxin load.

Intravenous Infusion in Pediatric Patients (<18 Years and Weighing <40 kg)

Under this EUA, single-dose vials may be used to prepare more than one pediatric dose; in addition, pediatric doses do not need to be diluted for patients <18 years and weighing <40 kg. 1

Materials Needed

IV Bag

  • 1 bamlanivimab vial (700 mg/20 mL)
  • 1 etesevimab vial (700 mg/20 mL)
  • 1 sterile, empty 50-mL PVC or PE-lined PVC infusion bag
  • 1 PVC or PE-lined PVC infusion set
  • 1 in-line or add-on 0.2/0.22 micron PES filter
  • 0.9% sodium chloride for flushing1

Syringe Pump

  • 1 bamlanivimab vial (700 mg/20 mL)
  • 1 etesevimab vial (700 mg/20 mL)
  • 1 disposable syringe
  • 1 syringe extension set
  • 1 syringe pump
  • 0.9% sodium chloride for flushing1

Preparation

  • Remove bamlanivimab and 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 vials. Inspect vials.
  • Withdraw appropriate amounts of bamlanivimab and etesevimab from vials based on body weight and inject into the empty infusion bag or draw into a disposable syringe (see Recommended Dosing, Preparation, and Administration Instructions for Undiluted Bamlanivimab and Etesevimab for IV Infusion in Pediatric Patients (<18 Years and Weighing Less Than 40 kg)).
    • Multiple doses of bamlanivimab and etesevimab may be prepare from each product vial. Prepare all infusion bags or syringes at the same time. Appropriately label any prepared doses including the patient weight and dose, and time of preparation to minimize risk of medication errors, particularly in cases where multiple doses are prepared simultaneously.
  • Gently invert the infusion bag or syringe to mix the contents. Do not shake or vigorously agitate.1

Administration

Recommended Dosing, Preparation, and Administration Instructions for Undiluted Bamlanivimab and Etesevimab for IV Infusion in Pediatric Patients (<18 Years and Weighing Less Than 40 kg)1

Druga: Add undiluted bamlanivimab and etesevimab to a sterile, empty 50-mL infusion bag OR a syringe and infuse all contents over at least 16 minutes

Body Weight, kg

BAM/ETE dose, mg

Amount of Bamlanivimab, mLb

Amount of Etesevimab, mLb

Maximum Infusion Rate, mL/min

>20 to <40

350/700

10

20

1.88

>12 to 20

175/350

5

10

0.94

>11 to 12

138/276

3.9

7.9

0.74

>10 to 11

126/252

3.6

7.2

0.68

>9 to 10

114/228

3.3

6.5

0.61

>8 to 9

102/204

2.9

5.8

0.54

>7 to 8

90/180

2.6

5.1

0.48

>6 to 7

78/156

2.2

4.5

0.42

>5 to 6

66/132

1.9

3.8

0.36

>4 to 5

54/108

1.5

3.1

0.29

>3 to 4

42/84

1.2

2.4

0.23

>2 to 3

30/60

0.9

1.7

0.16

>1.5 to 2

21/42

0.6

1.2

0.11

1 to 1.5 

15/30

0.4

0.9

0.08

aPediatric patients weighing less than 40 kg will receive bamlanivimab and etesevimab at doses adjusted for body weight. Pediatric patients weighing >20 kg to <40 kg will receive 350-mg bamlanivimab and 700-mg etesevimab. Pediatric patients weighing >12 kg to 20 kg will receive 175-mg bamlanivimab and 350-mg etesevimab. Pediatric patients weighing 1.5-12 kg will receive 15-mg/kg bamlanivimab and 30-mg/kg etesevimab.

bAmount of BAM (as mL) and amount of ETE (as mL) for patients weighing up to 12 kg are calculated and rounded to one decimal place.

Use of In-line Filter for IV Bag vs Syringe Pump Administration

As stated in the Fact Sheet and agreed upon by the FDA, an in-line filter is strongly recommended for IV bag infusions (all ages). A filter is not required when used with syringe pumps.3

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

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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