Bamlanivimab (Page 2 of 12)

Contraindications

None.

Dosing

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

Preparation and Administration

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.

Storage

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.

Warnings

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.

Side Effects

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.

INSTRUCTIONS FOR HEALTHCARE PROVIDERS

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 vaccinated 3 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 medications 4) 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.

MANDATORY REQUIREMENTS FOR BAMLANIVIMAB AND ETESEVIMAB ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION:

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 vaccinated 3 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 medications 4) 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.