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 administer bamlanivimab and etesevimab together to a patient?

Bamlanivimab and etesevimab infusion solution should be administered by a qualified healthcare professional.

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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 Professionals

Administration of IV Infusion in Adults (≥18 years regardless of weight) and Pediatric Patients (<18 years and weighing at least 40 kg)  

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.

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.

Bamlanivimab and Etesevimab Additional Clinical Data

Accelerated Infusion Times

Lilly proposed updated infusion times for bamlanivimab and etesevimab when added to prefilled infusion bags containing 50 mL, 100 mL, 150 mL and 250 mL of 0.9% Sodium Chloride for Injection.3

The minimum infusion times were calculated based on the final volumes of the bamlanivimab and etesevimab solution that would be infused, using a constant maximum infusion rate of 310 mL/hour, with an exception for patients weighing less than 50 kg (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)). An example of the calculation has been provided below for reference

  • 20 mL bamlanivimab + 40 mL etesevimab added to 50 mL prefilled bag = 110 mL total for infusion 
  • (110 mL x 1 hour x 60 minutes) / (310 mL x 1 hour) = 21.3 minutes, rounded to 21 minutes. 3

Endotoxin Limit

The endotoxin limit is based on the following calculation, K/M = EL, where

  • K = TPD, a constant determined by the statistical assessment of the levels of endotoxin activity that it takes to induce a fever in a rabbit.
    • For products administered IV or IM, the TPD is 5 EU/kg/hr.
  • M = the maximum dose of the material per kg of patient and per hour of total administration (dose/kg/hr).4

Therefore, for bamlanivimab and etesevimab together, to stay within the endotoxin limit for this high volume (250 mL 0.9% Normal Saline + 20 mL bamlanivimab 700 mg + 40 mL etesevimab 1400 mg), the infusion time was extended to 70 minutes for patients weighing <50 kg.1

Types of IV Bags, Infusion Sets and Lines for Administration

Lilly has not performed specific compatibility studies with bamlanivimab and etesevimab to support the use of the various types of IV Bags and infusion sets available on the market globally. Lilly recommends the use of the materials specified in the HCP fact sheet for bamlanivimab and etesevimab together.1,3

If alternate materials are used, the composition of these materials should be confirmed with that vendor.3

The type of IV line used to administer bamlanivimab and etesevimab is not specified (via a PICC line, central line, port, etc).1

BLAZE-1 Patient Monitoring

During the BLAZE-1 clinical trial, patients were monitored during the infusion as well as for at least 2 hours after completion of the infusion.5

Immediately prior to the infusion and 30 minutes after completion of the infusion, the following vital signs were assessed

  • body temperature
  • pulse rate
  • blood pressure
  • respiratory rate
  • SpO2 at rest, and
  • supplemental oxygen flow rate, FiO2 if known, and method of delivery, if applicable. 5

During the infusion, only record pulse rate, BP and SpO2.5

Automation was permitted to be used to measure vital signs.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 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.

4McCullough KZ. Calculating Endotoxin Limits for Drug Products. American Pharmaceutical Review. 2018. Accessed February 22, 2021. https://www.americanpharmaceuticalreview.com/Featured-Articles/353977-Calculating-Endotoxin-Limits-for-Drug-Products/

5Gottlieb 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

Glossary

BAM = bamlanivimab

COVID-19 = coronavirus disease 2019

EL = endotoxin limit

ETE = etesevimab

EU = endotoxin unit

EUA = emergency use authorization

FDA = Food and Drug Administration

IM = intramuscular

IV = intravenous

Lilly = Eli Lilly and Company

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

TPD = threshold pyrogenic dose

US = United States

Date of Last Review: December 23, 2021


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