bamlanivimab

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 alone to a patient?

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

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Bamlanivimab Emergency Use Authorization

Bamlanivimab has not been approved, but has been authorized for emergency use by FDA, to treat 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 is authorized only 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 bamlanivimab 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 mandatory requirements under the EUA, please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at bamlanivimab.com. 

Bamlanivimab Fact Sheet for Healthcare Providers

Bamlanivimab IV Infusion Administration

Bamlanivimab 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 0.20/0.22 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 (Recommended Dilution and Administration Instructions for Bamlanivimab). 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 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 Bamlanivimaba2

Drug: Add 20mL Bamlanivimab (1 vial) 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

270 mL/hr

16 minutes

100 mL

270 mL/hr

27 minutes

150 mL

270 mL/hr

38 minutes

250 mL

270 mL/hr

60 minutes

Abbreviation: hr=hour

a700 mg of bamlanivimab (20 mL) is added to an infusion bag and administered as a single intravenous infusion.

A video depiction of the administration of bamlanivimab alone 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 Additional Clinical Data

Types of IV Bags, Infusion Sets and Lines for Administration

Lilly has not performed specific compatibility studies with bamlanivimab 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.2,3

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 is not specified (via a PICC line, central line, port, etc).2

Accelerated Infusion Times

Lilly proposed updated infusion times for bamlanivimab 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 solution that would be infused, using a constant maximum infusion rate of 270 mL/hour (the currently authorized maximum infusion rate for bamlanivimab). An example of the calculation has been provided below for reference

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.4

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

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

During the infusion, every 30 minutes as possible, pulse rate, temperature, respiratory rate, BP and SpO2 were monitored.4

Automation was permitted to be used to measure vital signs.4

References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

1United States Food and Drug Administration. Bamlanivimab FDA Emergency Use Authorization Letter. Issued November 9, 2020. Accessed November 9, 2020. http://pi.lilly.com/eua/bamlanivimab-eua-fda-authorization-letter.pdf

2U. S. Food and Drug Administration (FDA). Fact Sheet for Health Care Providers. Emergency Use Authorization (EUA) of bamlanivimab. 2021.

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

4Chen P, Nirula A, Heller B, et al; BLAZE-1 Investigators. SARS-CoV-2 neutralizing antibody LY-CoV555 in outpatients with covid-19. N Engl J Med. Published online October 28, 2020. https://doi.org/10.1056/nejmoa2029849

Glossary

BP = blood pressure

COVID-19 = coronavirus disease 2019

EUA = emergency use authorization

FDA = Food and Drug Administration

FiO2 = fractional inspired oxygen

IV = intravenous

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

SpO2 = peripheral capillary oxygen saturation

Date of Last Review: March 03, 2021


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