Bamlanivimab and etesevimab are not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency.1

FDA’s determination and any updates will be available at: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs.1

FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility and CDC regional variant frequency data available at:  https://covid.cdc.gov/covid-data-tracker/#variant-proportions.1

Bamlanivimab and etesevimab are not authorized for use in patients 2 years and older who are hospitalized due to COVID-19.1

The reasons for hospital admission may be different and the threshold for hospital admission may be lower for neonates, young infants and toddlers with COVID-19 compared to older children and adults. The authorization allows for young children (i.e., birth to 2 years of age) who are hospitalized with mild to moderate COVID-19 at the time of treatment to receive bamlanivimab and etesevimab.1

Bamlanivimab and etesevimab are not authorized for use in patients, regardless of age who require

• oxygen therapy and/or respiratory support due to COVID-19, OR
• 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.1

Treatment with bamlanivimab and etesevimab has not been studied in patients hospitalized due to COVID-19. Monoclonal antibodies, such as bamlanivimab and etesevimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation.1

The following medical conditions or other factors may place adults and pediatric patients, including neonates, at higher risk for progression to severe COVID-19:1 

• Older age (for example age ≥65 years of age)
• <1 year old
• Obesity or being overweight
• Pregnancy
• Chronic kidney disease
• Diabetes
• Immunosuppressive disease or immunosuppressive treatment
• Cardiovascular disease (including congenital heart disease) or hypertension
• Chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, and pulmonary hypertension)
• Sickle cell disease
• Neurodevelopmental disorders (for example, cerebral palsy) or other conditions that confer medical complexity (for example, genetic or metabolic syndromes and severe congenital anomalies)
• Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])

Other medical conditions or factors (for example, race or ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of bamlanivimab and etesevimab under the EUA is not limited to the medical conditions or factors listed above. For additional 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.1 

The dosage for treatment of COVID-19 in adults (18 years and older) and pediatric patients (<18 years and weighing at least 40 kg) is 700-mg bamlanivimab and 1400-mg etesevimab.1

The dosage for pediatric patients weighing less than 40 kg will vary depending on body weight

• >20 kg to <40 kg: 350 mg bamlanivimab and 700 mg etesevimab
• >12 kg to 20 kg: 175 mg bamlanivimab and 350 mg etesevimab
• 1 kg to 12 kg: 12 mg/kg bamlanivimab and 24 mg/kg etesevimab1
  

For treatment of COVID-19, bamlanivimab and etesevimab should be administered together as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.1

No dosage adjustment is recommended based on renal or mild hepatic impairment, during pregnancy or while lactating, or in geriatric patients.

• Based on population PK analysis, there is no difference in PK of bamlanivimab and etesevimab in patients with mild hepatic impairment compared to patients with normal hepatic function.1
• Bamlanivimab and etesevimab have not been studied in patients with moderate or severe hepatic impairment.1

Viral testing determines COVID-19 infection by detecting SARS-CoV-2 nucleic acid or antigen from the respiratory system (such as nasal or oral swabs or saliva) or blood. Therefore, viral tests directly test acute infection.4

The FDA has not authorized using antibody tests to diagnose SARS-CoV-2 infection, the virus that causes COVID-19. Antibody tests do not directly test for acute viral infection. Antibody tests can help determine whether the individual being tested was previously infected.4