Bamlanivimab and etesevimab are investigational medicines used to treat mild to moderate symptoms of COVID-19 in adults and adolescents (12 years of age and older who weigh at least 88 pounds (40 kg)), and who are at high risk for developing severe COVID-19 symptoms or the need for hospitalization. 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 treat people with COVID-19.

Bamlanivimab and etesevimab are supplied in separate injection vials and given as a one-time, single dose. The vials are mixed together and administered by infusion (injection given over a longer period of time).

Bamlanivimab and etesevimab are no longer authorized under Emergency Use Authorization (EUA) by the FDA for treatment of COVID-19 due to being unlikely to be active against the omicron variant.

In the future, if patients are likely to be infected or exposed to a variant that is susceptible to these treatments, then use of these treatments may be authorized again.

What is an Emergency Use Authorization?

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 or cleared product. The FDA may issue an EUA when certain criteria are met, which includes that there are no adequate, approved, and available alternatives. In addition, the FDA decision is based on the totality of scientific evidence available showing that it is reasonable to believe that the product meets certain criteria for safety, performance, and labeling and may be effective in treatment of patients during the COVID-19 pandemic. All of these criteria must be met to allow for the product to be used in the treatment of patients 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 product may no longer be used).

What is COVID-19?

COVID-19 is caused by a virus called a coronavirus. 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 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 your other medical conditions to become worse.

• Bamlanivimab and etesevimab are given to you at the same time through a vein (intravenous or IV).
• You will receive one dose of bamlanivimab and etesevimab by IV infusion. The infusion will take 21 - 60 minutes or longer. Your healthcare provider will determine the duration of your infusion.

Tell your healthcare provider about all of your medical conditions, including if you:

• have any allergies;

• are pregnant or plan to become pregnant;

• are breastfeeding or plan to breastfeed;

• have any serious illnesses; or

• are taking any medications (prescription, over-the-counter, vitamins, and herbal products).