Emergency Use Authorization (EUA) for the Treatment of COVID-19

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Important facts about bebtelovimab

Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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 progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate.
The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

What is COVID-19?

COVID-19 is a disease caused by a type of virus called a coronavirus. Common symptoms include fever, cough, and having trouble breathing.

Some people with COVID-19 have many symptoms, and some have few or no symptoms. And though most people get better within 2 weeks, some people are very sick for a long time — or even die.

There’s no way to know for sure who will get very sick with COVID-19, but some people are at higher risk, including older adults, and people with certain health conditions.

You can find more information about COVID-19 at combatcovid.hhs.gov.

What is bebtelovimab?

Bebtelovimab, pronounced: beb-te-LOV-i-mab

Bebtelovimab is a neutralizing antibody drug. When there’s a virus in your body, like COVID-19, your immune system makes antibodies to fight it off. But it takes time for your body to make antibodies for a new virus — and in the meantime, you could get very sick.

Bebtelovimab contains man made antibodies to help fight the virus. They do not have any COVID-19 virus in them.

Who is this drug for?

Individuals 12 and older who are considered high risk of getting very sick from COVID-19, 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, and for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate and may qualify for a monoclonal antibody treatment. Treatment should be administered within 7 days of symptom onset. Talk to your Healthcare Provider for additional information.

Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. Examples of risk factors that may make an individual at higher risk for progression to severe COVID-19 include, but are not limited to:

Obesity

Chronic Kidney Disease

Cardiovascular Disease / Hypertension

Chronic Lung Disease

Older age

Immunosuppressive Disease / Immunosuppressive Treatment

Diabetes

Pregnancy

These are not all the risk factors. Other risk factors can be found on the CDC website.

Please also reference the Fact Sheet for Patients, Parents and Caregivers (English) or Fact Sheet for Patients, Parents and Caregivers (Spanish). Together, you and your healthcare provider can decide if this treatment is an option for you or someone you care for.

Bebtelovimab is an investigational medicine used for the treatment of mild-to-moderate COVID-19 in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]):

with positive results of direct SARS-CoV-2 viral testing, and
who are at high risk¹ for progression to severe COVID-19, including hospitalization or death, and
for whom other COVID-19 treatment options approved or authorized by FDA are not available or clinically appropriate.

There is limited information known about the safety and effectiveness of using bebtelovimab for the treatment of mild-to-moderate COVID-19.

Bebtelovimab is not authorized for use in people who:

are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDC’s latest information on circulating variants by geographic area), or
are hospitalized due to COVID-19, or
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.

Warnings

Important possible side effects of bebtelovimab:

Allergic reactions. Allergic reactions can happen during and after injection with bebtelovimab. Tell your healthcare provider right away if you or your child develop any of the following signs and symptoms of allergic reaction:

fever, difficulty breathing, low oxygen level in your blood, chills, tiredness, fast or slow heart rate, chest discomfort or pain, weakness, confusion, nausea, headache, shortness of breath, low or high blood pressure, wheezing, swelling of your lips, face, or throat, rash including hives, itching, muscle aches, dizziness, feeling faint, and sweating. These reactions may be severe or life threatening.

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

These are not all the possible side effects of bebtelovimab. Not many people have received bebtelovimab. Serious and unexpected side effects may happen. All of the risks are not known at this time.

It is possible that bebtelovimab could interfere with your body's own ability to fight off a future infection of SARS-CoV-2. Similarly, bebtelovimab may reduce the body's immune response to a vaccine for SARS-CoV-2. Talk to your healthcare provider if you have any questions.

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

Have any allergies
Are pregnant or plan to become pregnant
Are breastfeeding or plan to breastfeed
Have any serious illnesses
Are taking any medicines (prescription, and over-the-counter, vitamins, or herbal products)

What if I am pregnant or breastfeeding?

There is limited experience treating pregnant women or breastfeeding mothers with bebtelovimab. Severe allergic reactions have been observed with administration of bebtelovimab, including in pregnant patients.

For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. If pregnant or breastfeeding, discuss your options and specific situation with your healthcare provider.

Read the Fact Sheet for Patients, Parents and Caregivers for more information about bebtelovimab.

¹ For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Healthcare providers should consider the benefit-risk for an individual patient.

BB CON ISI EUA 17MAY2022