Neutralizing Antibodies for COVID-19

February 9, 2021

Lilly is working tirelessly to supply these therapies widely. People can visit combatcovid.hhs.gov to find out more about antibody therapy. Additionally, patients and physicians can contact Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921), or visit covid.infusioncenter.org or the Health & Human Services (HHS) Therapeutics Distribution locator to find a potential treatment location near them.

The U.S. Food and Drug Administration has granted Emergency Use Authorization (EUA) for bamlanivimab and etesevimab together and bamlanivimab alone 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 progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab and etesevimab together and bamlanivimab alone have not been approved by the FDA for any use. It is not known if bamlanivimab and etesevimab together or bamlanivimab alone are safe and effective for the treatment of COVID-19.

Bamlanivimab and etesevimab together and bamlanivimab alone are authorized under EUA only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use under Section 564(b)(1) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Select Press Releases and Resources

Healthcare providers should review the Fact Sheet for information on the authorized use of bamlanivimab and etesevimab together and bamlanivimab alone and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English; Spanish) for bamlanivimab and etesevimab together. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients, Parents and Caregivers (English; Spanish) for bamlanivimab alone.

Authorized Use and Important Safety Information

Bamlanivimab and etesevimab together and bamlanivimab alone are authorized for use 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.

Limitations of Authorized Use

Bamlanivimab and etesevimab together and bamlanivimab alone are 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.

Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Benefit of treatment with bamlanivimab alone has not been observed in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high flow oxygen or mechanical ventilation.

Important Safety Information

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

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab and etesevimab together and bamlanivimab alone. 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 and etesevimab together and bamlanivimab 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, 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 of COVID-19 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

Treatment with bamlanivimab and etesevimab together has not been studied in patients hospitalized due to COVID-19. Benefit of treatment with bamlanivimab alone has not been observed in patient hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, 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

Bamlanivimab and etesevimab together

Based on Phase 2 data from BLAZE-1, nausea was the most commonly reported adverse event, reported by 4% of subjects in both bamlanivimab and etesevimab together and placebo groups. Pruritus and pyrexia were more frequently reported from subjects treated with both bamlanivimab and etesevimab (2% and 1%) compared to placebo (1% and 0%, respectively).

Based on Phase 3 data from BLAZE-1, the most common adverse events were nausea, dizziness, and rash. These events each occurred in 1% of subjects treated with bamlanivimab and etesevimab together and in 1% of placebo subjects.

Bamlanivimab alone

Adverse events reported in at least 1% of BLAZE-1 clinical trial participants on bamlanivimab 700 mg alone 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 on the use of bamlanivimab and etesevimab together and bamlanivimab alone during pregnancy. Bamlanivimab and etesevimab together and bamlanivimab alone 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 or etesevimab 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.

PP-LI-US-0374 02/2021 ©Lilly USA, LLC 2021. All rights reserved.

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