Label: ETESEVIMAB injection, solution

TREATMENT

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved products bamlanivimab and etesevimab administered together for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients, including neonates, 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.

Limitations of Authorized Use

• Bamlanivimab and etesevimab are 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 these drugs and regional variant frequency.
  • 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.1
• Bamlanivimab and etesevimab are not authorized for use in patients 2 years and older who are hospitalized due to COVID-19.2
• Bamlanivimab and etesevimab are not authorized for use in patients, regardless of age, who:
  • 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 bamlanivimab and etesevimab has not been studied 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.

POST-EXPOSURE PROPHYLAXIS

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved products bamlanivimab and etesevimab administered together in adults and pediatric individuals, including neonates, for post-exposure prophylaxis of COVID-19 in individuals who are at high risk of progression to severe COVID-19, including hospitalization or death, and are:

• not fully vaccinated3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications4) and
  • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
  • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].

Limitations of Authorized Use

• Bamlanivimab and etesevimab are not authorized for post-exposure prophylaxis of COVID-19 in geographic regions where exposure is likely to have been to a non-susceptible SARS-CoV-2 variant, based on available information including variant susceptibility to these drugs and regional variant frequency.
  • 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.1
• Post-exposure prophylaxis with bamlanivimab and etesevimab is not a substitute for vaccination against COVID-19.
• Bamlanivimab and etesevimab are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

1

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 [see Microbiology/Resistance Information (15)], and CDC regional variant frequency data available at: https://covid.cdc.gov/covid-data-tracker/#variant-proportions.

2

The reasons for hospital admission may be different and the threshold for hospital admission may be lower for neonates, young infants and toddlers with COVID-19 compared to older children and adults. The authorization allows for young children (i.e., birth to 2 years of age) who are hospitalized with mild to moderate COVID-19 at the time of treatment to receive bamlanivimab and etesevimab.

3

Individuals are considered to be fully vaccinated 2 weeks after their second vaccine dose in a 2-dose series (such as the Pfizer or Moderna vaccines), or 2 weeks after a single-dose vaccine (such as Johnson & Johnson's Janssen vaccine). See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/fully-vaccinated.html#vaccinated.

4

See this website for more details: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/fully-vaccinated-people.html.

5

Close contact with an infected individual is defined as: being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example). See this website for additional details: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html.

Bamlanivimab and etesevimab have been authorized by FDA for the emergency uses described above.

Bamlanivimab and etesevimab are not FDA-approved for these uses.

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

None.

See Full Fact Sheet for Healthcare Providers for information on dosing [see Dosage and Administration (2)].

See Full Fact Sheet for Healthcare Providers for information on preparation and administration [see Dose Preparation and Administration (2.4)].

Under this EUA, single-dose vials may be used to prepare more than one pediatric dose; in addition, pediatric doses do not need to be diluted for patients <18 years and weighing <40kg.

Refrigerate unopened vials at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze, shake, or expose to direct light.

FDA has authorized an extension to the shelf-life (i.e., expiration date) of both bamlanivimab and etesevimab following a thorough review of data submitted by Eli Lilly and Company. The extension applies to all unopened vials of bamlanivimab and etesevimab that have been held in accordance with storage conditions. Confirm the shelf-life of unopened vials of bamlanivimab and etesevimab by batch number at the FDA EUA website under the Drug and Biological Therapeutic Products bamlanivimab and etesevimab. This site includes a complete listing of extended expiration dates by batch number. If the batch number on the vial/carton is not included in this listing, the product is labeled with the correct expiration date.

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

Hypersensitivity Including Anaphylaxis and Infusion-Related Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of bamlanivimab and etesevimab. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration and initiate appropriate medications and/or supportive therapy.

Infusion-related reactions, occurring during the infusion and up to 24 hours after the infusion, have been observed with administration of bamlanivimab and etesevimab together. 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.

Consider slowing or stopping the infusion and administer appropriate medications and/or supportive care if an infusion-related reaction occurs.

Hypersensitivity reactions occurring more than 24 hours after the infusion have also been reported with the use of bamlanivimab and etesevimab under Emergency Use Authorization.

Clinical Worsening After Bamlanivimab and Etesevimab Administration

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

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

Treatment with bamlanivimab and etesevimab has not been studied 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. Therefore, [see Limitations of Authorized Use (1.1)]:

• Bamlanivimab and etesevimab are not authorized for use in patients 2 years and older who are hospitalized due to COVID-192,
• Bamlanivimab and etesevimab are not authorized for use in patients, regardless of age, who:
  • 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.

Adverse events have been reported with bamlanivimab and etesevimab [see Full EUA Prescribing Information, Overall Safety Summary (6.1)].

Additional adverse events associated with bamlanivimab and etesevimab, some of which may be serious, may become apparent with more widespread use.

As the healthcare provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the “Fact Sheet for Patients, Parents and Caregivers” (and provide a copy of the Fact Sheet) prior to the patient receiving bamlanivimab and etesevimab, including:

• FDA has authorized the emergency use of bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients, including neonates, 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 [see Limitations of Authorized Use (1.1)].
• FDA has authorized the emergency use of bamlanivimab and etesevimab administered together in adults and pediatric individuals, including neonates, for post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
  • not fully vaccinated3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications4) and
    • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
    • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].
• The patient or parent/caregiver has the option to accept or refuse bamlanivimab and etesevimab.
• The significant known and potential risks and benefits of bamlanivimab and etesevimab, and the extent to which such potential risks and benefits are unknown.
• Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials.
• Patients treated with bamlanivimab and etesevimab together should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines.

For information on clinical trials that are testing the use of bamlanivimab and etesevimab together for COVID-19, please see www.clinicaltrials.gov.

In order to mitigate the risks of using these unapproved products and to optimize the potential benefit of bamlanivimab and etesevimab under this EUA, the following items are required. Use of bamlanivimab and etesevimab under this EUA is limited to the following (all requirements must be met):

1. Treatment of mild to moderate COVID-19 in adults and pediatric patients, including neonates, 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 [see Limitations of Authorized Use (1.1)].
2. Post-exposure prophylaxis of COVID-19 in adults and pediatric individuals, including neonates, who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
   1. not fully vaccinated3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications4) and
      1. have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
      2. who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].
3. As the healthcare provider, communicate to your patient or parent/caregiver, as age appropriate, information consistent with the “Fact Sheet for Patients, Parents and Caregivers” prior to the patient receiving bamlanivimab and etesevimab. Healthcare providers (to the extent practicable given the circumstances of the emergency) must document in the patient's medical record that the patient/caregiver has been:
   1. Given the “Fact Sheet for Patients, Parents and Caregivers”,
   2. Informed of alternatives to receiving authorized bamlanivimab and etesevimab, and
   3. Informed that bamlanivimab and etesevimab are unapproved drugs that are authorized for use under this Emergency Use Authorization.
4. Patients with known hypersensitivity to any ingredient of bamlanivimab or etesevimab must not receive bamlanivimab and etesevimab.
5. The prescribing health care provider and/or the provider's designee is/are responsible for mandatory reporting of all medication errors and serious adverse events* potentially related to bamlanivimab and etesevimab treatment within 7 calendar days from the onset of the event. The reports must include unique identifiers and the words “bamlanivimab and etesevimab use for COVID-19 under Emergency Use Authorization (EUA)” in the description section of the report.
   • Submit adverse event reports to FDA MedWatch using one of the following methods:
     • Complete and submit the report online: www.fda.gov/medwatch/report.htm, or
     • Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by:
       • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
       • Fax (1-800-FDA-0178), or
     • Call 1-800-FDA-1088 to request a reporting form.
     • Submitted reports must include in the field name, “Describe Event, Problem, or Product Use/Medication Error” the statement “bamlanivimab and etesevimab use for COVID-19 under Emergency Use Authorization (EUA).”

     *Serious Adverse Events are defined as:

     • death;
     • a life-threatening adverse event;
     • inpatient hospitalization or prolongation of existing hospitalization;
     • a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
     • a congenital anomaly/birth defect;
     • a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.
6. The prescribing health care provider and/or the provider's designee is/are to provide mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of bamlanivimab and etesevimab.
7. OTHER REPORTING REQUIREMENTS
   • Healthcare facilities and providers must report therapeutics information and utilization data through HHS Protect, Teletracking or National Healthcare Safety Network (NHSN) as directed by the U.S. Department of Health and Human Services.
   • In addition, please provide a copy of all FDA MedWatch forms to:
     Eli Lilly and Company, Global Patient Safety
     Fax: 1-317-277-0853
     E-mail: mailindata_gsmtindy@lilly.com
     Or call Eli Lilly and Company at 1-855-LillyC19 (1-855-545-5921) to report adverse events.

Veklury (remdesivir) is FDA-approved for the treatment of 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, who are not hospitalized and have mild-to-moderate COVID-19, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Veklury is administered via intravenous infusion for a total treatment duration of 3 days.

Although Veklury is an approved alternative 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 progression to severe COVID-19, including hospitalization or death, FDA does not consider Veklury to be an adequate alternative to bamlanivimab and etesevimab for this authorized use because it may not be feasible or practical for certain patients (e.g., it requires a 3-day treatment duration).6

There is no adequate, approved and available alternative to bamlanivimab and etesevimab administered together for post-exposure prophylaxis of COVID-19 in adult and pediatric individuals, including neonates, who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:

• not fully vaccinated3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications4) and
  • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
  • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].

Additional information on COVID-19 therapies can be found at https://www.cdc.gov/coronavirus/2019-ncov/index.html. The health care provider should visit https://clinicaltrials.gov/ to determine whether the patient may be eligible for enrollment in a clinical trial.

6

Additionally, the approval for Veklury does not cover certain pediatric patients for whom bamlanivimab and etesevimab administered together is authorized (e.g., patients less than 12 years of age).

The Secretary of the Department of Health and Human Services (HHS) has declared a public health emergency that justifies the emergency use of drugs and biological products during the COVID-19 pandemic. FDA has issued this EUA, requested by Eli Lilly and Company for the unapproved products bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients, including neonates, 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.5

FDA has also issued this EUA, requested by Eli Lilly and Company for the unapproved products bamlanivimab and etesevimab administered together in adults and pediatric individuals, including neonates, for post-exposure prophylaxis of COVID-19 in individuals who are at high risk of progression to severe COVID-19, including hospitalization or death, and are:

• not fully vaccinated3 or who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (for example, individuals with immunocompromising conditions including those taking immunosuppressive medications4) and
  • have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC)5 or
  • who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons) [see Limitations of Authorized Use (1.2)].

Although limited scientific information is available, based on the totality of the scientific evidence available to date, it is reasonable to believe that bamlanivimab and etesevimab administered together may be effective for the treatment of mild to moderate COVID-19 or for post-exposure prophylaxis of COVID-19 in individuals as specified in this Fact Sheet. You may be contacted and asked to provide information to help with the assessment of the use of the product during this emergency.

This EUA for bamlanivimab and etesevimab will end when the Secretary determines that the circumstances justifying the EUA no longer exist or when there is a change in the approval status of the product such that an EUA is no longer needed.

As a health care provider, you must comply with the mandatory requirements of the EUA (see above).

CONTACT INFORMATION
For additional information visit
www.LillyAntibody.com

If you have questions, please contact
1-855-LillyC19 (1-855-545-5921)

FULL EUA PRESCRIBING INFORMATION

Bamlanivimab is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution available as:

• Injection: 700 mg/20 mL (35 mg/mL) in a single-dose* vial.

Etesevimab is a sterile, preservative-free, clear to opalescent and colorless to slightly yellow to slightly brown solution available as:

• Injection: 700 mg/20 mL (35 mg/mL) in a single-dose* vial.

* Under this EUA, single-dose vials may be used to prepare more than one pediatric dose.

None.

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

Clinically monitor patients during administration and observe patients for at least 1 hour after infusion is complete [see Warnings and Precautions (5.1) and Overall Safety Summary (6.1)].

Clinical trials evaluating the safety of bamlanivimab and etesevimab are ongoing [see Overall Safety Summary (6)].

Completion of FDA MedWatch Form to report all medication errors and serious adverse events* occurring during bamlanivimab and etesevimab use and considered to be potentially related to bamlanivimab and etesevimab is mandatory and must be done by the prescribing healthcare provider and/or the provider's designee. These adverse events must be reported within 7 calendar days from the onset of the event:

*Serious adverse events are defined as:

• death;
• a life-threatening adverse event;
• inpatient hospitalization or prolongation of existing hospitalization;
• a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
• a congenital anomaly/birth defect;
• a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.

If a serious and unexpected adverse event occurs and appears to be associated with the use of bamlanivimab and etesevimab under this EUA, the prescribing healthcare provider and/or the provider's designee must complete and submit a MedWatch form to FDA using one of the following methods:

• Complete and submit the report online: www.fda.gov/medwatch/report.htm, or
• Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by:
  • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
  • Fax (1-800-FDA- 0178), or
• Call 1-800-FDA-1088 to request a reporting form

IMPORTANT: When reporting adverse events or medication errors to MedWatch, please complete the entire form with detailed information. It is important that the information reported to FDA be as detailed and complete as possible. Information that must be included:

• Patient demographics (e.g., patient initials, date of birth)
• Pertinent medical history
• Pertinent details regarding adverse events and course of illness
• Concomitant medications
• Timing of adverse event(s) in relationship to administration of bamlanivimab and etesevimab
• Pertinent laboratory and virology information
• Outcome of the event and any additional follow-up information if it is available at the time of the MedWatch report. Subsequent reporting of follow-up information should be completed if additional details become available.

The following steps are highlighted to provide the necessary information for safety tracking:

1. In section A, box 1, provide the patient's initials in the Patient Identifier
2. In section A, box 2, provide the patient's date of birth
3. In section B, box 5, description of the event:
   1. Write “bamlanivimab and etesevimab use for COVID-19 under Emergency Use Authorization (EUA)” as the first line
   2. Provide a detailed report of medication error and/or adverse event. It is important to provide detailed information regarding the patient and adverse event/medication error for ongoing safety evaluation of this unapproved drug. Please see information to include listed above.
4. In section G, box 1, name and address:
   1. Provide the name and contact information of the prescribing healthcare provider or institutional designee who is responsible for the report.
   2. Provide the address of the treating institution (NOT the healthcare provider's office address).

• Healthcare facilities and providers must report therapeutics information and utilization data through HHS Protect, Teletracking or National Healthcare Safety Network (NHSN) as directed by the U.S. Department of Health and Human Services.
• In addition, please provide a copy of all FDA MedWatch forms to:
  Eli Lilly and Company, Global Patient Safety
  Fax: 1-317-277-0853
  E-mail: mailindata_gsmtindy@lilly.com
  Or call Eli Lilly and Company at 1-855-LillyC19 (1-855-545-5921) to report adverse events.

Bamlanivimab and etesevimab are not renally excreted or metabolized by cytochrome P450 enzymes; therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of cytochrome P450 enzymes are unlikely.

Doses up to 7,000 mg of bamlanivimab (10 times the authorized dose of bamlanivimab for adults [≥18 years] and pediatric patients [<18 years weighing at least 40 kg]) or 7,000 mg of etesevimab (5 times the authorized dose of etesevimab for adults [≥18 years] and pediatric patients [<18 years weighing at least 40 kg]) have been administered in clinical trials without dose-limiting toxicity. Treatment of overdose with bamlanivimab and etesevimab should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient. There is no specific antidote for overdose with either bamlanivimab or etesevimab.

Carcinogenesis, mutagenesis, and reproductive toxicology studies with bamlanivimab or etesevimab have not been conducted.

In toxicology studies, bamlanivimab and etesevimab had no adverse effects when administered intravenously to rats and monkeys, respectively. Non-adverse increases in neutrophils were observed in rats dosed with bamlanivimab.

In tissue cross reactivity studies using human adult and fetal tissues, no binding of clinical concern was detected for bamlanivimab or etesevimab.

Patients treated with bamlanivimab and etesevimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high touch” surfaces, and frequent handwashing) according to CDC guidelines. Also see Fact Sheet for Patients, Parents and Caregivers.

For additional information visit:
www.LillyAntibody.com

If you have questions, please contact:
1-855-LillyC19 (1-855-545-5921)

Literature revised January 24, 2022

Eli Lilly and Company, Indianapolis, IN 46285, USA
Copyright © 2021, 2022, Eli Lilly and Company. All rights reserved.

ETE-0009-EUA HCP-20220124

Fact Sheet for Patients, Parents and Caregivers

Emergency Use Authorization (EUA) of Bamlanivimab and Etesevimab for Coronavirus Disease 2019 (COVID-19)

You or your child are being given two medicines together called bamlanivimab and etesevimab for the treatment or post-exposure prophylaxis for prevention of coronavirus disease 2019 (COVID-19). SARS-CoV-2 is the virus that causes COVID-19. This Fact Sheet contains information to help you understand the potential risks and potential benefits of taking bamlanivimab and etesevimab.

Receiving bamlanivimab and etesevimab may help to treat COVID-19 in certain people, or help to prevent COVID-19 in certain people who have been exposed to someone infected with SARS-CoV-2 or who are at high risk of an exposure because of being in the same setting, such as nursing homes or prisons.

Read this Fact Sheet for information about bamlanivimab and etesevimab. Talk to your or your child's healthcare provider if you have questions. It is your choice if you or your child receive bamlanivimab and etesevimab or you may stop them at any time.

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus, SARS-CoV-2. People can get COVID-19 through contact with another person who has the virus.

COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, serious illness can happen and may cause some of your or your child's other medical conditions to become worse. People of all ages with severe, long-lasting (chronic) medical conditions like heart disease, lung disease, and diabetes, for example, and other conditions including obesity, seem to be at higher risk of being hospitalized for COVID-19. Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19.

What are the symptoms of COVID-19?

The symptoms of COVID-19 include fever, cough, and shortness of breath, which may appear 2 to 14 days after exposure. Serious illness including breathing problems can occur and may cause other medical conditions to become worse.

What are bamlanivimab and etesevimab?

Bamlanivimab and etesevimab are investigational medicines used together in adults and children who are at high risk for developing severe COVID-19, including hospitalization or death for:

• treatment of mild to moderate symptoms of COVID-19, OR
• post-exposure prophylaxis for prevention of COVID-19 in persons who are:
  • not fully vaccinated against COVID-19 (Individuals are considered to be fully vaccinated 2 weeks after their second dose in a 2-dose series [such as the Pfizer or Moderna vaccines], or 2 weeks after a single-dose dose vaccine [such as Johnson & Johnson's Janssen vaccine]), or
  • are not expected to build up enough of an immune response to the complete COVID-19 vaccination (for example, someone with immunocompromising conditions, including someone who is taking immunosuppressive medications), and
    • have been exposed to someone who is infected with SARS-CoV-2. Close contact with someone who is infected with SARS-CoV-2 is defined as being within 6 feet for a total of 15 minutes or more, providing care at home to someone who is sick, having direct physical contact with the person (hugging or kissing, for example), sharing eating or drinking utensils, or being exposed to respiratory droplets from an infected person (sneezing or coughing, for example). For additional details, go to https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/quarantine.html, or
    • someone who is at high risk of being exposed to someone who is infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting (for example, nursing homes, prisons).

Bamlanivimab and etesevimab are investigational because they are still being studied. There is limited information known about the safety or effectiveness of using bamlanivimab and etesevimab to treatment or prevention of COVID-19. Bamlanivimab and etesevimab are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

The FDA has authorized the emergency use of bamlanivimab and etesevimab together for the treatment of COVID-19 and the post-exposure prophylaxis for prevention of COVID-19 under an Emergency Use Authorization (EUA). For more information on EUA, see the section “What is an Emergency Use Authorization (EUA)?” at the end of this Fact Sheet.

What should I tell the healthcare provider before I or my child receive bamlanivimab and etesevimab?

Tell the healthcare provider about all of your or your child's medical conditions, including:

• Having any allergies
• Having received a COVID-19 vaccine
• Having any serious illnesses
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed
• Are taking any medications (prescription, over-the-counter, vitamins, and herbal products)

How are bamlanivimab and etesevimab given?

• Bamlanivimab and etesevimab are given at the same time through a vein (intravenous or IV).
• One dose of bamlanivimab and etesevimab will be given by IV infusion. The infusion will take 16 – 60 minutes or longer. Your or your child's healthcare provider will determine the duration of the infusion.

What are the important possible side effects of bamlanivimab and etesevimab?

Possible side effects of bamlanivimab and etesevimab are:

• Allergic reactions. Allergic reactions can happen during and after infusion with bamlanivimab and etesevimab. Tell your or your child's healthcare provider right away if any of the following signs and symptoms of allergic reactions occur: fever, chills, nausea, headache, shortness of breath, low or high blood pressure, rapid or slow heart rate, chest discomfort or pain, weakness, confusion, feeling tired, wheezing, swelling of the lips, face, or throat, rash including hives, itching, muscle aches, feeling faint, dizziness, and sweating. These reactions may be severe or life threatening.
• Worsening of COVID-19 symptoms after bamlanivimab and etesevimab therapy for active infection: You or your child may experience new or worsening symptoms after infusion for mild to moderate COVID-19, including fever, difficulty breathing, rapid or slow heart rate, tiredness, weakness or confusion. If these occur, contact your or your child's healthcare provider or seek immediate medical attention as some of these events have required hospitalization. It is unknown if these events are related to treatment or are due to the progression of COVID-19.

The side effects of getting any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

These are not all the possible side effects of bamlanivimab and etesevimab. Not a lot of people have been given bamlanivimab and etesevimab. Serious and unexpected side effects may happen. Bamlanivimab and etesevimab are still being studied so it is possible that all of the risks are not known at this time.

It is possible that bamlanivimab and etesevimab could interfere with your or your child's body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bamlanivimab and etesevimab may reduce the body's immune response to a vaccine for SARS-CoV-2. Specific studies have not been conducted to address these possible risks. Talk to your or your child's healthcare provider if you have any questions.

What other treatment choices are there?

Like bamlanivimab and etesevimab, FDA may allow for the emergency use of other medicines to treat people with COVID-19. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are not approved by FDA to treat people with COVID-19. Your or your child's healthcare provider may talk with you about clinical trials you or your child may be eligible for.

It is your choice whether you or your child should be treated or not to be treated with bamlanivimab and etesevimab. Should you decide that you or your child should not receive bamlanivimab and etesevimab or stop it at any time, it will not change your or your child's standard medical care.

What other prevention choices are there?

Vaccines to prevent COVID-19 are approved or available under Emergency Use Authorization. Use of bamlanivimab and etesevimab does not replace vaccination against COVID-19.

Like bamlanivimab and etesevimab, FDA may allow for the emergency use of other medicines for post-exposure prophylaxis for prevention of COVID-19. Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are not approved by FDA for post-exposure prophylaxis for prevention of COVID-19. The healthcare provider may talk with you about clinical trials you or your child may be eligible for.

Bamlanivimab and etesevimab are not authorized for pre-exposure prophylaxis for prevention of COVID-19.

What if I am pregnant or breastfeeding?

There is limited experience treating pregnant women or breastfeeding mothers with bamlanivimab and etesevimab. For a mother and unborn baby, the benefit of receiving bamlanivimab and etesevimab may be greater than the risk from the treatment. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

How do I report side effects with bamlanivimab and etesevimab?

Tell the healthcare provider right away if you or your child have any side effect that bothers you or your child, or does not go away.

Report side effects to FDA MedWatch at www.fda.gov/medwatch, call 1-800-FDA-1088, or contact Eli Lilly and Company at 1-855-LillyC19 (1-855-545-5921).

How can I learn more?

• Ask your or your child's healthcare provider
• Visit www.LillyAntibody.com
• Visit https://www.covid19treatmentguidelines.nih.gov/
• Contact your local or state public health department

What is an Emergency Use Authorization (EUA)?

The United States FDA has made bamlanivimab and etesevimab available under an emergency access mechanism called an EUA. The EUA is supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic.

Bamlanivimab and etesevimab have not undergone the same type of review as an FDA-approved product. In issuing an EUA under the COVID-19 public health emergency, the FDA must determine, among other things, that based on the totality of scientific evidence available, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. All of these criteria must be met to allow for the medicine to be used in the treatment of COVID-19 or prevention of COVID-19 during the COVID-19 pandemic.

The EUA for bamlanivimab and etesevimab together is in effect for the duration of the COVID-19 declaration justifying emergency use of these products, unless terminated or revoked (after which the products may no longer be used).

Literature revised December 3, 2021

Eli Lilly and Company, Indianapolis, IN 46285, USA

Copyright © 2021, Eli Lilly and Company. All rights reserved.

ETE-0005-EUA PAT-20211203

PACKAGE LABEL- etesevimab Injection 700 mg/20 mL (35 mg/mL) Vial Carton

NDC 0002-7950-01

Lilly

etesevimab injection

700 mg/20 mL
(35 mg/mL)

For Intravenous Infusion Only

Must dilute before use

Single-Dose Vial: Discard Unused Portion

For use under Emergency Use Authorization (EUA).

MUST ADMINISTER WITH BAMLANIVIMAB