Usual Adult Dose for COVID-19

For investigational use only

175 mg IV as a single dose

Comments:

• The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of this drug for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, AND who are at high risk for progression to severe COVID-19, including hospitalization or death, AND for whom alternative COVID-19 treatment options approved or authorized by the US FDA are not accessible or clinically appropriate; this drug is not approved by the US FDA for this or any use.
• November 30, 2022: Due to the high frequency of circulating SARS-CoV-2 variants that are nonsusceptible to this drug, bebtelovimab is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.
• This drug should be administered as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
• No dose adjustment recommended in elderly patients or in pregnant or lactating patients.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

• with positive results of direct SARS-CoV-2 viral testing, AND
• who are at high risk for progression to severe COVID-19, including hospitalization or death, AND
• for whom alternative COVID-19 treatment options approved or authorized by US FDA are not accessible or clinically appropriate

Usual Pediatric Dose for COVID-19

For investigational use only

12 years or older and weighing at least 40 kg: 175 mg IV as a single dose

Comments:

• The US FDA issued an EUA to allow the emergency use of this drug for the treatment of mild to moderate COVID-19 in patients with positive results of direct SARS-CoV-2 viral testing, AND who are at high risk for progression to severe COVID-19, including hospitalization or death, AND for whom alternative COVID-19 treatment options approved or authorized by the US FDA are not accessible or clinically appropriate; this drug is not approved by the US FDA for this or any use.
• November 30, 2022: Due to the high frequency of circulating SARS-CoV-2 variants that are nonsusceptible to this drug, bebtelovimab is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.
• This drug should be administered as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.
• No dose adjustment recommended in pregnant or lactating patients.
• For additional information: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs

• with positive results of direct SARS-CoV-2 viral testing, AND
• who are at high risk for progression to severe COVID-19, including hospitalization or death, AND
• for whom alternative COVID-19 treatment options approved or authorized by US FDA are not accessible or clinically appropriate

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Liver Dose Adjustments

Mild liver dysfunction: No adjustment recommended.
Moderate or severe liver dysfunction: Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years; this drug is not authorized for use in pediatric patients weighing less than 40 kg or those younger than 12 years.

Dialysis

Data not available

Other Comments

November 30, 2022: Due to the high frequency of circulating SARS-CoV-2 variants that are nonsusceptible to this drug, bebtelovimab is not currently authorized in any US region; therefore, this drug may not be administered for treatment of COVID-19 under the EUA until further notice by the US FDA.

Administration advice:

• This drug may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction (e.g., anaphylaxis) and the ability to activate the emergency medical system, as needed.
• Administer the entire contents of the syringe via IV injection over at least 30 seconds.
• Use a disposable polypropylene dosing syringe that can hold 2 mL.
• Optional: A syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP).
• After the entire contents of the syringe have been administered, flush the injection line with 0.9% Sodium Chloride to ensure the required dose has been delivered.
• Clinically monitor patients for possible infusion-related reactions during administration and observe patients for at least 1 hour after injection is complete.

• Unopened vials: Store in refrigerator at 2C to 8C (36F to 46F) in original carton to protect from light; do not freeze, shake, or expose to direct light.
• Remove vial from refrigerated storage and allow to equilibrate to room temperature for about 20 minutes before preparation; do not expose to direct heat; do not shake the vial.
• Prepared syringe: Should administer immediately; if immediate administration is not possible, store for up to 24 hours in refrigerator (2C to 8C [36F to 46F]) and for up to 7 hours at room temperature (20C to 25C [68F to 77F]). If refrigerated, allow to equilibrate to room temperature for about 20 minutes prior to administration.

• This drug should be prepared by a qualified health care professional.
• The Fact Sheet for Health Care Providers should be consulted.

• Compatible: 0.9% Sodium Chloride Injection

• This drug is currently authorized in all US regions until further notice by the US FDA.
• Limitations of Authorized Use:
• This drug is not authorized for treatment of mild to moderate COVID-19 in geographic regions where infection is likely due to nonsusceptible SARS-CoV-2 variant based on available information such as variant susceptibility to this drug and regional variant frequency; the US 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 US CDC regional variant frequency data (https://covid.cdc.gov/covid-data-tracker/#variant-proportions).
• This drug is not authorized for use in patients who are hospitalized due to COVID-19, OR who require oxygen therapy and/or respiratory support due to COVID-19, OR who require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 in those on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity.
• Treatment with this drug has not been studied in patients hospitalized due to COVID-19; monoclonal antibodies (such as this drug) may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 who require high flow oxygen or mechanical ventilation.
• The US CDC website (https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html) should be consulted for information on medical conditions and factors associated with increased risk for progression to severe COVID-19. The benefit-risk should be considered for each patient.
• The Fact Sheet for Health Care Providers should be consulted regarding available alternatives.
• ClinicalTrials.gov should be consulted for information on clinical trials of this drug and other therapies for the treatment of COVID-19.

• Read the Fact Sheet for Patients, Parents, and Caregivers.
• Continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect "high touch" surfaces, frequent handwashing) according to US CDC guidelines.