Bebtelovimab Dosage

Medically reviewed by Drugs.com. Last updated on Dec 2, 2022.

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

Use: 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 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

Use: 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 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.

Storage requirements:

• 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.

Reconstitution/preparation techniques:

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

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection

General:

• 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.

Patient advice:

• 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.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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