bebtelovimab

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, administer, and monitor bebtelovimab for treatment of COVID-19?

Bebtelovimab injection should be prepared by a qualified healthcare professional using aseptic technique and patients should be monitored for at least 1 hour after injection.

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Bebtelovimab Emergency Use Authorization

Bebtelovimab has not been approved, but has 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 bebtelovimab 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

Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (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 progression to severe COVID-19, including hospitalization or death, and
  • for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.1,2

For information on the authorized use of bebtelovimab 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/bebtelovimab. 1,2

Bebtelovimab Fact Sheet for Healthcare Providers

Preparation and Administration

General Information

  • Bebtelovimab should be prepared by a qualified healthcare professional using aseptic technique.
  • Inspect bebtelovimab vial visually for particulate matter and discoloration. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Discard the vial if the solution is cloudy, discolored, or visible particles are observed.
  • Bebtelovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary.
  • Clinically monitor patients for possible infusion-related reactions during administration and observe patients for at least 1 hour after injection is complete.1

Materials Needed for Administration

  • 1 bebtelovimab vial (175 mg/2 mL)
  • 1 disposable polypropylene dosing syringe capable of holding 2 mL
  • 0.9% Sodium Chloride injection for flushing.
  • Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP).1

Preparation and Administration

  • Remove bebtelovimab 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 vial. Inspect the vial.
  • Withdraw 2 mL from the vial into the disposable syringe.
  • Discard any product remaining in the vial.
  • This product is preservative-free and therefore, should be administered immediately.
    • If immediate administration is not possible, store the syringe 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]). If refrigerated, allow the prepared syringe to equilibrate to room temperature for approximately 20 minutes prior to administration.
  • If used, attach and prime the syringe extension set.
  • Administer the entire contents of the syringe via intravenous (IV) injection over at least 30 seconds.
  • After the entire contents of the syringe have been administered, flush the injection line with 0.9% Sodium Chloride to ensure delivery of the required dose.1

Bebtelovimab Additional Clinical Data from BLAZE-4

BLAZE-4 is a phase 2, randomized, single-dose clinical trial evaluating treatment of non-hospitalized patients with mild-to-moderate COVID-19.1

Bebtelovimab was among the treatment interventions studied in BLAZE-4. It was evaluated alone and together with bamlanivimab and etesevimab in

  • low-risk adults (ie, those not at high-risk to progress to severe COVID-19 aged 18 to <65) and compared to a placebo control arm, and
  • high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments.1

Because there are other therapeutic options available, a placebo control could not be used to treat high-risk patients.1

Administration Route in BLAZE-4 Clinical Trial

The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Bebtelovimab should be administered via IV injection over at least 30 seconds. Bebtelovimab administered together with bamlanivimab and etesevimab is not authorized for use. Please see the enclosed Fact Sheet for authorized dosing information.

In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3

  • In low-risk patients, treatment arms included
    • bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR
    • bebtelovimab 175mg, bamlanivimab 700 mg and etesevimab 1400 mg administered together (total dose volume 62.5 mL) via IV infusion over at least 6.5 minutes, OR 
    • placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes.3
  • In high-risk patients, treatment arms included
    • bebtelovimab 175mg alone administered via IV push over at least 30 seconds, OR
    • bebtelovimab 175mg, bamlanivimab 700 mg and etesevimab 1400 mg administered together (total dose volume 62.5 mL) via IV infusion over at least 6.5 minutes.3

In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3

Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3

Rationale for Administration via IV Push

The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3

Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3

Other Methods of Administration

There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3

Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers.

Additional Aseptic Technique Information

Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of the bebtelovimab 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 the bebtelovimab injection.3

Bebtelovimab contains no preservative. The bebtelovimab injection should be prepared by a qualified healthcare professional using aseptic technique to prevent contamination from pathogens.3

Bebtelovimab is neither hazardous nor toxic when spilled.3

The bebtelovimab 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 intravenous injection.1,3

Types of Syringes and Extension Sets for Administration

In the BLAZE-4 clinical trial protocol preparation instructions, syringes and extension sets (syringe/IV extension sets) were used when administering bebtelovimab via IV push or using a syringe pump over at least 30 seconds.3

In BLAZE-4, the type of materials provided in the clinical trial protocol preparation instructions included

  • syringes
    • polypropylene
  • infusion lines and extension sets
    • polyvinylchloride (PVC) with or without DEHP and with or without a 0.20/0.22 µm polyether sulfone (PES) filter

    • polyethylene with or without a 0.20/0.22 µm PES filter.3

The use of an infusion line or extension set with an in-line filter was strongly recommended, whenever possible, to mitigate the risk of contamination. 3

The bebtelovimab dosing instructions do not specify a particular brand of disposable dosing syringe or extension set to be used and Lilly does not provide guidance in this regard.3

There are no known incompatibilities between bebtelovimab and available disposable dosing syringes in the market.3

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

Priming of Extension Set

In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3

References

1Fact sheet for healthcare providers. Emergency Use Authorization (EUA) of bebtelovimab. US Food and Drug Administration (FDA). 2022.

2United States Food and Drug Administration. Bebtelovimab FDA Emergency Use Authorization letter. Issued February 11, 2022. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf

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

Date of Last Review: April 21, 2022


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