What is Bebtelovimab?
Bebtelovimab was an investigational drug employed as part of an Emergency Use Authorization (EUA) to treat mild-to-moderate corona virus disease (COVID-19) in adults and children (12 years old and older) weighing at least 40 kg [88 lbs]. :
- Positive results of tests for the SARS-CoV-2 virus directly, and
- people who are at a high risk of progression to severe COVID-19, which could lead to death or hospitalization and
- who require COVID-19 treatment options approved by FDA or granted by FDA aren't accessible or clinically relevant.
There is not much information available about the safety and efficacy of bebtelovimab in the treatment of moderate to mild COVID-19.
On November 30th, 2022, the FDA declared that bebtelovimab was not yet approved for emergency usage within the U.S. at this time since it isn't anticipated to neutralize subvariants of Omicron BQ.1 as well as BQ.1.1.
Bebtelovimab was not approved to be used by people who:
- Are likely to be infected with a variant of SARS-CoV-2 that cannot be treated with bebtelovimab, depending on the circulating variants within your local area (ask your doctor regarding the FDA and CDC's current information regarding circulating variants according to geographical area), or
- Patients are hospitalized because of COVID-19 or
- need oxygen therapy or respiratory assistance due to COVID-19 or
- need to increase their oxygen flow rates at baseline or respiratory support due to COVID-19 and who are receiving chronic oxygen therapy or respiratory support due to COVID-19-related comorbidities that are not COVID-19-related.
What is an emergency use authorization?
In the United States, the FDA has made bebtelovimab accessible under an emergency access system known as the Emergency Use Authorization (EUA). The EUA was later cancelled on November 30, 2022. The EUA was backed by an official declaration from the Secretary of Health and Human Services (HHS) stating that the circumstances are there to justify the emergency use of biological and pharmaceutical products in the COVID-19 epidemic.
Bebtelovimab has not been subjected to the same kind of review as an FDA-approved drug. In granting an EUA under COVID-19, a public health emergency the FDA decided that among other things that based upon the complete amount of evidence that is available, which includes data from controlled and reliable clinical studies and controlled clinical trials, it is reasonable to believe the drug could be effective in diagnosing and treating or the prevention of COVID-19, or any dangerous or life-threatening illness or disease caused by COVID-19. that the established and possible benefits of this product, when utilized to treat or prevent this disease or condition, are greater than the risks that are known and possible of the product and that there is no alternative to the product alternative that is approved and readily available.
All of these requirements must be met in order for the drug to be used in the treatment of patients undergoing the COVID-19 epidemic. This EUA for bebtelovimab remained valid until it was cancelled due to its inability to neutralize current Omicron variants BQ.1 and BQ.1.1. Bebtelovimab, therefore, cannot be used in the future as per the EUA. Bebtelovimab is currently not an emergency use authorization (EUA) medicine and was never an FDA-approved medication for use in the United States.
Prior to receiving Bebelovemab
Before getting treatment, inform your doctor about all of your or the child's medical issues, such as the following:
- Are you a victim of allergies?
- Are you pregnant or planning to get pregnant?
- Are you breastfeeding or planning to breastfeed?
- Have you been diagnosed with any serious illnesses?
- Are you taking any medications (prescription and over-the-counter, herbal, or vitamins)?
Interaction with other drugs
Interactions between bebtelovimab and other drugs aren't likely.
How to take Bebelovemab?
Bebtelovimab is given by injection into an IV (intravenously or intravenous) for at least 30 minutes. You will be supervised by your physician for at least one hour after receiving bebtelovimab.
Details on dosage
Usual Adult Dose for COVID-19
175 mg of bebtelovimab given by intravenous injection lasting 30 seconds at a minimum Treatment for mild to moderate coronavirus infection 2019 (COVID-19) for individuals who are at a high risk of developing a severe illness Take the medication as soon as is possible after the positive results of direct SARS-CoV-2 testing, as well as within seven days from the onset of symptoms.
Usual Pediatric Dose for COVID-19
175 mg of bebtelovimab is administered in a single injection for a minimum of 30 minutes. Treatment for mild to moderate coronavirus infection 2019 (COVID-19) for children (>=12 years old and weighing a minimum of 40 kilograms) who are at a high chance of developing severe disease It is recommended to administer it as soon as possible after the positive results of SARS-CoV-2 virus testing and within 7 days after the onset of symptoms.
Side effects of Bebtelovimab
- Allergy reactions. Allergic reactions can occur before and after the injection of bebtelovimab. Inform your healthcare professional immediately if you or your child exhibit symptoms or signs of allergic reactions.
- The fever.
- Difficulties breathing.
- Low oxygen levels in your blood.
- Heart rate that is slow or fast.
- Chest pain or discomfort.
- High or low blood pressure.
- The swelling of your lips, your face or the throat.
- Itchy rash, including hives.
- Muscle aches.
- Feeling weak, feeling faint.
The reactions could be serious or life-threatening.
Common side effects include reactions, pruritus, and an itchy rash.The negative side effects of receiving any medication via vein could include bleeding, pain or bruising on the skin, itchiness, swelling, and possibly infections at the site of injection.This is not the only list of possible negative side effects. Many people have not experienced bebtelovimab. Unexpected and serious side effects could occur. All potential risks aren't fully understood currently.
Consult your doctor if you experience any side effects that irritate you or don't disappear. Report side effects to FDA MedWatch at www.fda.gov/medwatch, or call 1-800-FDA-1088, or call Eli Lilly and Company, Inc. at 1-855-LillyC19 (1-855-545-5921).It's possible that bebtelovimab may affect your body's capability to defend against SARS-CoV-2 infection in the future. Bebtelovimab, in turn, can hinder the body's response to vaccinations for SARS-CoV-2. Consult your doctor if you have any problems.
What other options for treatment are available?
As with bebtelovimab, the FDA could allow the use of emergency medications to treat patients suffering from 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 authorized by the FDA to treat people with COVID-19.Your doctor may discuss with you clinical studies for those who may be eligible.
It is up to you or your children to receive treatment or not with bebtelovimab.If you decide not to be a recipient or your child decides not to receive it, it won't affect the standard of your child's medical treatment.
What happens if I'm nursing or pregnant?
There is a lack of experience treating nursing or pregnant moms using bebtelovimab. If a mother is pregnant and has an unborn baby, the advantages of taking bebtelovimab could outweigh the risks of receiving the treatment. If you're breastfeeding or pregnant, consider discussing your options and the specifics of your circumstances with your healthcare professional.