Lilly
  • For Consumers
    • Getting Started
    • FAQ and Resources
  • House For Healthcare Providers
    • Bamlanivimab Antibody Playbook
    • Access
    • Dosage and Administration
    • Clinical Data
    • FAQ and Resources
Ask Lilly

We're here to help.

Phone Call:
Lilly COVID Hotline
(1-855-545-5921)
Link Visit Lilly Medical (HCP)
Question Submit a Question
Expand contact lilly
Skip to main content

Access

As of March 24, 2021, the U.S. Government, in coordination with Eli Lilly and Company, has stopped the distribution of bamlanivimab alone in the United States. Direct ordering for bamlanivimab and etesevimab together will continue as normal. Sites with sufficient bamlanivimab on hand can order etesevimab alone to pair with existing bamlanivimab inventory.

It is important to remember that etesevimab cannot be administered alone and should be administered together with bamlanivimab in accordance with the Emergency Use Authorization (EUA). For information on the EUA for the administration of bamlanivimab and etesevimab together, click here.

bamlanivimab vial box
frequently asked questions about COVID-19 antibody treatment icon frequently asked questions about COVID-19 antibody treatment icon

Frequently Asked Questions

FAQs regarding access to bamlanivimab

As of March 24, 2021, the U.S. Government, in coordination with Eli Lilly and Company, has stopped the distribution of bamlanivimab alone in the United States. Direct ordering for bamlanivimab and etesevimab together will continue as normal.

Sites with sufficient bamlanivimab on hand can order etesevimab alone to pair with existing bamlanivimab inventory. Etesevimab will be ordered in patient courses of treatment (1 patient course of treatment=2 vials of etesevimab). Sites will have to attest that they have enough bamlanivimab on hand to pair with the number of patient courses of etesevimab they are ordering and that they will administer bamlanivimab with etesevimab as per the EUA. This will only be done on the direct order smart sheet order form, located here.

It is important to remember that etesevimab cannot be administered alone and should be administered together with bamlanivimab in accordance with the Emergency Use Authorization (EUA). For information on the EUA for the administration of bamlanivimab and etesevimab together, click here.

Sites with bamlanivimab on hand will now be able to order etesevimab alone to pair with it. Etesevimab will be ordered in patient courses of treatment (1 patient course of treatment=2 vials of etesevimab). Sites will have to attest that they have enough bamlanivimab on hand to pair with the number of patient courses of treatment of etesevimab they are ordering and that they will administer bamlanivimab with etesevimab as per the EUA. This will only be done on the direct order smart sheet order form.

For more information about the EUA for bamlanivimab and etesevimab together, please visit www.bamandete.com.

Bamlanivimab has been purchased by the federal government and is provided at no cost to states, sites of care, or patients upon direct order from AmerisourceBergen. For Medicare patients, the Medicare program will cover and pay for Covid-antibody infusion expenses in accordance with Section 3713 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). Commercial reimbursement will be variable based on the individual plan. Patients should check with their individual site of care to see what, if any, infusion-related expenses they may be charged.

Services and ancillary expenses necessary to administer the infusion are the responsibility of the individual site of care and can be billed according to published Centers for Medicare & Medicaid Services (CMS) guidance found at www.cms.gov for Medicare patients. CMS identified specific code(s) for the monoclonal antibody product and specific administration code(s) for Medicare payment:

Q0239:

  • Long descriptor: Injection, bamlanivimab, 700mg
  • Short descriptor: bamlanivimab-xxxx

M0239:

  • Long descriptor: intravenous infusion, bamlanivimab-xxxx, includes infusion and post administration monitoring
  • Short descriptor: bamlanivimab-xxxx infusion

Any location with outpatient infusion capabilities can administer bamlanivimab.

Eligible sites can order product directly through AmerisourceBergen by filling out the C19 Therapies Direct Order Request.

For information on establishing infusion site units, please reference Lilly’s Infusion Units for COVID-19 Antibody Treatment Operations Guide. This resource provides recommendations for establishing infusion units to treat patients with COVID-19 in diverse settings. It was developed based on Lilly’s experience working with health networks and hospital systems to establish separate pop-up infusion units.

You can also reference Lilly’s COVID Antibody Infusion Clinic Learnings document, which outlines learnings based on Lilly’s experience working with health networks and hospital systems to establish pilot infusion centers across Indiana.

For information on which monoclonal antibody treatments are available at certain infusion sites, you should contact the site itself for more information on which product(s) they have in inventory. Please note that product availability may change at any time.

Clinical investigators, hospitals or clinical sites interested in participating in one of Lilly’s clinical trials for a potential COVID-19 treatment should call 1-877-CT-LILLY (1-877-285-4559) or email covid19potentialsite@lilly.com.

genuine bamlanivimab icon genuine bamlanivimab icon

Genuine bamlanivimab

Ensuring the authenticity of bamlanivimab

Eli Lilly and Company is committed to patient safety and ensuring that people have accurate information about investigational bamlanivimab, including how it is accessed and administered. We are actively monitoring for fraudulent offers of illegitimate bamlanivimab to protect patients from products that might be dangerous and lead to serious and life-threatening harm.

Checkmark
Bamlanivimab is authorized in the United States for use under an EUA and can only be accessed through the request of a treating physician.
Checkmark
Bamlanivimab is only administered intravenously.
Checkmark
Bamlanivimab is not taken orally and is not available in a capsule or tablet form.
Checkmark
Authentic bamlanivimab, manufactured by Eli Lilly and Company, will include the Lilly name and logo on the label, and is dispensed in a vial with either a salmon or slate cap.
Checkmark
Bamlanivimab is not sold online.
Checkmark
The authenticity of products acquired outside of the legitimate supply chain cannot be verified by Eli Lilly and Company.

If you believe you have purchased or have been offered counterfeit bamlanivimab, please report it to the FDA.

Bamlanivimab is authorized for use for 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.

  • Bamlanivimab has not been approved, but has been authorized for emergency use by FDA.
  • Bamlanivimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the 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.

Limitations of Authorized Use

  • Bamlanivimab is not authorized for use in patients:
    • who are hospitalized due to COVID-19, OR
    • who require oxygen therapy due to COVID-19, OR
    • who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
  • Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, may be associated with worse clinical outcomes in hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Important Safety Information

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

WARNINGS
Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab. 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 have been observed with administration of bamlanivimab. 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, dizziness, and diaphoresis.

If an infusion-related reaction occurs, consider slowing or stopping the infusion and administer appropriate medications and/or supportive care.

Clinical Worsening After Bamlanivimab Administration

Clinical worsening after administration of bamlanivimab 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 bamlanivimab use or were due to progression of COVID-19.

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

Benefit of treatment with bamlanivimab has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab, 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 Events

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg or placebo were nausea (3% vs 4%), diarrhea (1% vs 5%), dizziness (3% vs 2%), headache (3% vs 2%), pruritus (2% vs 1%) and vomiting (1% vs 3%).

USE IN SPECIFIC POPULATIONS
Pregnancy

There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Bamlanivimab 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 bamlanivimab 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 bamlanivimab and mandatory requirements of the EUA. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers.

BAM HCP EUA ISI 28JAN2021

Fact Sheet for Healthcare Providers
Dear HCP Letter Correction of Drug Information: Preparation and Administration Instructions
Dear HCP Letter: Bamlanivimab and Etesevimab, Preventing Medication Errors
Fact Sheet for Patients, Parents and Caregivers (English)
Fact Sheet for Patients, Parents and Caregivers (Spanish)
FDA Letter of Authorization
Terms of Use
Privacy Statement
Accessibility Statement
Sitemap
Ask Lilly

We're here to help.

Phone Call:
Lilly COVID Hotline
(1-855-545-5921)
Link Visit Lilly Medical (HCP)
Question Submit a Question

This site is intended for US healthcare providers only.

PP-BM-US-0029 03/2021 ©Lilly USA, LLC 2021. All rights reserved.

All product/company names shown herein are the trademarks of their respective owners.

Terms of Use Privacy Statement Accessibility Statement Sitemap
Lilly