Bamlanivimab

Kathryn Dzintars, Pharm.D., BCPS
Bamlanivimab is a topic covered in the Johns Hopkins ABX Guide.

To view the entire topic, please or .

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

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.

  • *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

-- To view the remaining sections of this topic, please or --

INDICATIONS

FDA

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.

  • *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

There's more to see -- the rest of this entry is available only to subscribers.

Last updated: December 7, 2020