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Frequently Asked Questions

  • Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) 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.
  • The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

With the United States government’s supply of bebtelovimab expected to be exhausted by mid-to-late August 2022, Lilly intends to make bebtelovimab commercially available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through a sole distributor beginning the week of August 15, 2022. Please see more information here.

Distribution of bebtelovimab will continue solely through AmerisourceBergen Specialty Distribution (ASD). Most provider sites are accustomed to ordering COVID-19 antibodies from ASD.

Lilly does not intend to put a stringent allocation model in place; however, we plan to monitor and implement controls to prevent purchase patterns that may cause inequitable access to the available supply of bebtelovimab.

No, there is no change to packaging or the NDC (0002-7589-01) for bebtelovimab. Government purchased product and commercially purchased product will be distinguished by batch number. Future batch numbers will be added as available.

Government Purchased Batch Numbers Commercially Purchased Batch Numbers
Government Purchased Batch Numbers D476887 Commercially Purchased Batch Numbers D534422
Government Purchased Batch Numbers D476886 Commercially Purchased Batch Numbers D542203
Government Purchased Batch Numbers D487999 Commercially Purchased Batch Numbers D552306
Government Purchased Batch Numbers D480382
Government Purchased Batch Numbers D488000
Government Purchased Batch Numbers D492098
Government Purchased Batch Numbers D494710
Government Purchased Batch Numbers D493128
Government Purchased Batch Numbers D533218

Upon commercial launch during the week of August 15, 2022, bebtelovimab will be available to purchase from ASD. To ensure your site has immediate access to purchase bebtelovimab, please see the below guidance:

  • Existing AmerisourceBergen Accounts
    • AmerisourceBergen will sell bebtelovimab to licensed and approved customers such as hospitals, infusion centers, long term care facilities, clinics, etc. As a reminder, retail pharmacies are unable to purchase bebtelovimab.
  • Sites Without an AmerisourceBergen Account
    • To purchase bebtelovimab, your site will need to have a fully vetted commercial account with AmerisourceBergen. To initiate the account creation process, please contact the account set up team at the following email address: asdaccountsetup@amerisourcebergen.com.

If you have any questions regarding the procurement of bebtelovimab commercially, please contact AmerisourceBergen at c19therapies@amerisourcebergen.com.

The Wholesale Acquisition Cost (WAC) of bebtelovimab is $2,100.

For information on Eli Lilly and Company's COVID-19 clinical trials, please click here. Patients interested in participating in one of our clinical trials for a potential COVID-19 treatment should visit Lilly TrialGuide for information regarding eligibility for ongoing trials.

In May 2022, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 12 months to 18 months for specific lots of the refrigerated Lilly monoclonal antibody, bebtelovimab, which is currently authorized for emergency use. FDA granted this extension following a thorough review of data submitted by Lilly. Commercialized product, batch D534422, will be distributed already labeled with 18-month expiration dates.

While there are some similarities, here’s how they are different:

  • Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Vaccines provide active immunity by helping the body make its own antibodies to protect itself.
  • Monoclonal antibody drugs are designed to start working faster than vaccines, while protection provided by vaccines will generally last longer.
  • Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines.

To date, there is no data available from Lilly clinical studies regarding the efficacy and safety of a SARS-CoV-2 vaccine after receipt of monoclonal antibodies for the treatment of mild-to-moderate COVID-19. It is no longer necessary to delay COVID-19 vaccination following receipt of monoclonal antibodies or convalescent plasma.1

Based on the estimated half-life of such therapies and evidence suggesting that reinfection is uncommon within the 90 days after initial infection, vaccination should be deferred for at least 90 days after receiving monoclonal antibodies. This is a precautionary measure until additional information becomes available, to avoid potential interference of the antibody therapy with vaccine-induced immune responses. This recommendation applies to people who receive passive antibody therapy before receiving any vaccine dose and between doses. Receipt of passive antibody therapy in the past 90 days is not a contraindication to receipt of COVID-19 vaccine. COVID-19 vaccine doses received within 90 days after receipt of passive antibody therapy do not need to be repeated.1

References 1. Centers for Disease Control and Prevention (CDC). Interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States. Updated February 11, 2022. Accessed February 11, 2022. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html.

Authorized Use

Bebtelovimab is authorized to be administered 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 risk1 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.

Limitations of Authorized Use

  • Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency.
    • FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.
    • FDA's determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.
  • Bebtelovimab is not authorized for use in patients, who:
    • are hospitalized due to COVID-19, OR
    • require oxygen therapy and/or respiratory support due to COVID-19, OR
    • require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
  • Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.
  • Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19.
  • Bebtelovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner.

IMPORTANT SAFETY INFORMATION

The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization.

WARNINGS AND PRECAUTIONS

There are limited clinical data available for bebtelovimab. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use.

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care.

Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. These reactions may be severe or life-threatening. Signs and symptoms of infusion-related reactions may include:

  • fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. atrial fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g. pre-syncope, syncope), dizziness, and diaphoresis.

Administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization.

Clinical Worsening After Monoclonal Antibody Administration

Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. Some of these events required hospitalization. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19.

Limitations of Benefit and Potential Risk in Patients with Severe COVID-19

Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. See Limitations of Authorized Use.

Adverse Reactions

Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%).

USE IN SPECIFIC POPULATIONS
Pregnancy

Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care.

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus.

Breastfeeding

There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19.

Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab.

BB HCP EUA ISI 17MAY2022

1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient.

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