- The FDA issued an Emergency Use Authorization (EUA) permitting the use of bamlanivimab for the treatment of mild to moderate coronavirus disease in adult and pediatric (≥ 12 years of age; ≥40 kg) 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.
- FDA issued a EUA (2/4/21) for the combination of bamlanivimab and etesevimab.
- *High risk is defined as:
- Have a body mass index (BMI) ≥ 35
- Have chronic kidney disease
- Have diabetes
- Have immunosuppressive disease
- Are currently receiving immunosuppressive treatment
- Are ≥65 years of age
- ≥ 55 years of age AND must have one of the following
- Cardiovascular disease OR
- Hypertension OR
- COPD/other chronic respiratory diseases
- Are 12 – 17 years of age AND have one of the following
- BMI ≥85th percentile for their age and gender based on CDC growth charts (https://www.cdc.gov/growthcharts/clinical_charts.htm), OR
- Sickle cell disease, OR
- Congenital or acquired heart disease, OR
- Neurodevelopmental disorders, for example, cerebral palsy, OR
- Medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19), OR
- Asthma, reactive airway or other chronic respiratory diseases that require daily medication for control.
Bamlanivimab 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
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Last updated: February 15, 2021
Dzintars, Kathryn. "Bamlanivimab." Johns Hopkins ABX Guide, The Johns Hopkins University, 2021. Pediatrics Central, peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540755/all/Bamlanivimab.
Dzintars K. Bamlanivimab. Johns Hopkins ABX Guide. The Johns Hopkins University; 2021. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540755/all/Bamlanivimab. Accessed June 10, 2023.
Dzintars, K. (2021). Bamlanivimab. In Johns Hopkins ABX Guide. The Johns Hopkins University. https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540755/all/Bamlanivimab
Dzintars K. Bamlanivimab [Internet]. In: Johns Hopkins ABX Guide. The Johns Hopkins University; 2021. [cited 2023 June 10]. Available from: https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540755/all/Bamlanivimab.
* Article titles in AMA citation format should be in sentence-case
TY - ELEC T1 - Bamlanivimab ID - 540755 A1 - Dzintars,Kathryn,Pharm.D., BCPS Y1 - 2021/02/15/ BT - Johns Hopkins ABX Guide UR - https://peds.unboundmedicine.com/pedscentral/view/Johns_Hopkins_ABX_Guide/540755/all/Bamlanivimab PB - The Johns Hopkins University DB - Pediatrics Central DP - Unbound Medicine ER -