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 prepare the IV infusion of bamlanivimab alone?

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

US_cFAQ_BAM010B_DOSE_PREPARATION_COVID-19
cFAQ
cFAQ
US_cFAQ_BAM010B_DOSE_PREPARATION_COVID-19
en-US

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 Preparation

Bamlanivimab 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)-lined PVC, sterile pre-filled infusion bag. Choose one of the following sizes:
    • One 20 mL vial of bamlanivimab (700 mg/20 mL).
  • Remove 1 bamlanivimab vial 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 vial. 
  • Inspect bamlanivimab visually for particulate matter and discoloration
    • Bamlanivimab is a clear to slightly opalescent and colorless to slightly yellow to slightly brown solution.
  • Withdraw 20 mL bamlanivimab from one 20 mL vial and inject into a prefilled infusion bag containing 0.9% Sodium Chloride Injection (see Recommended Dilution and Administration Instructions for Bamlanivimab).
  • Discard any product remaining in the vial.
  • Gently invert IV bag by hand approximately 10 times to mix. Do not shake.
  • This product is preservative-free and therefore, should be administered immediately.
    • If immediate administration is not possible, store the diluted bamlanivimab 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 come to room temperature for approximately 20 minutes prior to administration.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 preparation of the bamlanivimab alone IV infusion can be found here.

Bamlanivimab Additional Clinical Data

Additional Aseptic Technique Information

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

Bamlanivimab is neither hazardous nor toxic when spilled.  The use of a laminar flow cabinet, hood, or a negative air pressure room is not required unless specified by the institution’s aseptic technique directive.3

Lilly does not provide an aseptic technique directive for the preparation of the bamlanivimab solution for infusion as 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

Various Infusion Bag Sizes

Lilly conducted assessments to determine if 20 mL of bamlanivimab could be added into a 50 mL, 150 mL, or 250 mL IV bags of  0.9% Sodium Chloride, considering the nominal overfill volumes in the bags. 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

    263 - 285 mLd

    273 mL

    ICU Medical

    100 mL

    103 - 113 mLe

    107 mL

    250 mL

    260 - 300 mLf

    270 mL

    Terumo (Japan)

    100 mL

    NA

    102 mL

    250mL

    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

    fICU 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. No leakage of solution was noted upon gently squeezing the bags. These data are consistent with the physical findings for the Baxter bags as well.3

    Therefore, given that the volume of bamlanivimab to be added to the prefilled IV bag is 20 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).

    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.

    Glossary

    COVID-19 = coronavirus disease 2019

    EUA = emergency use authorization

    FDA = Food and Drug Administration

    IV = intravenous

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

    Date of Last Review: March 03, 2021


    Contact Lilly

    Call Us

    If you have immediate questions regarding COVID-19, or to report an Adverse Event or Product Complaint, please call us.

    Daily Live Support: 9am to 7pm ET.
    After Hours: Call Back Support Available

    Or you can

    Chat with us

    Chat with us

    Submit a Request

    Visit Us @LillyMedical