Johns Hopkins ABX Guide
Bebtelovimab
Bebtelovimab is a topic covered in the Johns Hopkins ABX Guide.
To view the entire topic, please log in or purchase a subscription.
Official website of the Johns Hopkins Antibiotic (ABX), HIV, Diabetes, and Psychiatry Guides, powered by Unbound Medicine. Johns Hopkins Guide App for iOS, iPhone, iPad, and Android included. Explore these free sample topics:
-- The first section of this topic is shown below --
INDICATIONS
FDA
FDA
- EUA withdrawn on 11/30/22 due to inadequate neutralization against circulating Omicron sublineage viruses.
- The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of bebtelovimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) patients with a positive SARS-CoV-2 test who are at high risk* for progressing to severe disease or hospitalization. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals.
*High risk is defined as:
- Have a body mass index (BMI) ≥ 35
- Have chronic kidney disease
- Have diabetes
- Have cardiovascular disease (including congenital heart disease) or hypertension
- Have chronic lung disease
- Are pregnant
- Have sickle cell disease
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Have neurodevelopmental disorders
- Are ≥65 years of age
- Are ≥ 55 years of age AND have cardiovascular disease OR hypertension OR COPD/other chronic respiratory diseases
Bebtelovimab is NOT authorized for use in patients:
- Who are hospitalized due to COVID-19, or
- Who require oxygen therapy due to COVID-19, or
- Who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
-- To view the remaining sections of this topic, please log in or purchase a subscription --
INDICATIONS
FDA
FDA
- EUA withdrawn on 11/30/22 due to inadequate neutralization against circulating Omicron sublineage viruses.
- The FDA issued an Emergency Use Authorization (EUA) permitting the emergency use of bebtelovimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) patients with a positive SARS-CoV-2 test who are at high risk* for progressing to severe disease or hospitalization. This EUA restricts treatment to outpatient administration only. It is not approved for use within hospitals.
*High risk is defined as:
- Have a body mass index (BMI) ≥ 35
- Have chronic kidney disease
- Have diabetes
- Have cardiovascular disease (including congenital heart disease) or hypertension
- Have chronic lung disease
- Are pregnant
- Have sickle cell disease
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Have neurodevelopmental disorders
- Are ≥65 years of age
- Are ≥ 55 years of age AND have cardiovascular disease OR hypertension OR COPD/other chronic respiratory diseases
Bebtelovimab is NOT authorized for use in patients:
- Who are hospitalized due to COVID-19, or
- Who require oxygen therapy due to COVID-19, or
- Who require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19–related comorbidity
There's more to see -- the rest of this topic is available only to subscribers.
Last updated: December 12, 2022
Citation
Dzintars, Kathryn . "Bebtelovimab." Johns Hopkins ABX Guide, The Johns Hopkins University, 2022. Johns Hopkins Guides, www.hopkinsguide.com/hopkins/view/Johns_Hopkins_ABX_Guide/540768/all/Bebtelovimab.
Dzintars K. Bebtelovimab. Johns Hopkins ABX Guide. The Johns Hopkins University; 2022. https://www.hopkinsguide.com/hopkins/view/Johns_Hopkins_ABX_Guide/540768/all/Bebtelovimab. Accessed March 20, 2023.
Dzintars, K. (2022). Bebtelovimab. In Johns Hopkins ABX Guide. The Johns Hopkins University. https://www.hopkinsguide.com/hopkins/view/Johns_Hopkins_ABX_Guide/540768/all/Bebtelovimab
Dzintars K. Bebtelovimab [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2022. [cited 2023 March 20]. Available from: https://www.hopkinsguide.com/hopkins/view/Johns_Hopkins_ABX_Guide/540768/all/Bebtelovimab.
* Article titles in AMA citation format should be in sentence-case
TY - ELEC
T1 - Bebtelovimab
ID - 540768
A1 - Dzintars,Kathryn ,Pharm.D., BCPS
Y1 - 2022/12/12/
BT - Johns Hopkins ABX Guide
UR - https://www.hopkinsguide.com/hopkins/view/Johns_Hopkins_ABX_Guide/540768/all/Bebtelovimab
PB - The Johns Hopkins University
DB - Johns Hopkins Guides
DP - Unbound Medicine
ER -
