bamlanivimab and etesevimab together

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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 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 progressing to severe COVID-19 and/or hospitalization.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 progressing to severe COVID-19 and/or hospitalization 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 BAMandETE.com.

Bamlanivimab and Etesevimab Fact Sheet for Healthcare Professionals

Bamlanivimab and Etesevimab IV Infusion Administration

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

  • Gather the materials for infusion:
    • Polyvinyl chloride (PVC) or Polyethylene (PE)-lined PVC infusion set 
    • Use of an in-line or add-on 0.2/0.22 micron polyethersulfone (PES) filter is strongly recommended.
  • Attach the infusion set to the IV bag.
  • 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 Patients Weighing 50 kg or More  or Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusion in Patients Weighing Less Than 50 kg). Due to potential overfill of pre-filled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage.
  • 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.
  • Once infusion is complete, flush the tubing with 0.9% Sodium Chloride to ensure delivery of the required dose.
  • 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 has not been studied.2
Recommended Dilution and Administration Instructions for Bamlanivimab and Etesevimab for IV Infusiona in Patients Weighing 50 kg or More 2


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 kg2


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).

 A video depiction of the administration of the bamlanivimab and etesevimab IV infusion can be found here.

Patient Monitoring

Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete.2

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 Patients Weighing Less Than 50 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.2

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).2

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).

1United States Food and Drug Administration. Bamlanivimab and Etesevimab FDA Emergency Use Authorization Letter. Issued February 9, 2021. Accessed February 9, 2021. http://pi.lilly.com/eua/bam-and-ete-eua-fda-authorization-letter.pdf

2Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bamlanivimab and etesevimab. US Food and Drug Administration (FDA). 2021.

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. JAMA. Published online January 21, 2021. 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

Date of Last Review: February 19, 2021


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