Usual Adult Dose for COVID-19

For investigational use only

500 mg IV as a single dose

Comments:

• The Secretary of Health and Human Services (HHS) has issued an Emergency Use Authorization (EUA) for the emergency use of sotrovimab 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; this drug is not approved by the US FDA for this or any use.
• April 5, 2022: Due to the high frequency of circulating SARS-CoV-2 variants that are nonsusceptible to this drug, sotrovimab 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 IV within 7 days of symptom onset.
• No dose adjustment recommended in older adult 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 who are at high risk for progression to severe COVID-19, including hospitalization or death

Usual Pediatric Dose for COVID-19

For investigational use only

12 years or older:

• At least 40 kg: 500 mg IV as a single dose

Comments:

• The Secretary of HHS has issued an EUA for the emergency use of sotrovimab 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; this drug is not approved by the US FDA for this or any use.
• April 5, 2022: Due to the high frequency of circulating SARS-CoV-2 variants that are nonsusceptible to this drug, sotrovimab 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 IV 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 who are at high risk for progression to severe COVID-19, including hospitalization or death

Renal Dose Adjustments

Renal dysfunction: No adjustment recommended.

Comments:

• Renal dysfunction is not expected to affect the pharmacokinetics of this drug.

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• History of anaphylaxis to the active component or any of the ingredients

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

Comments:

• Dialysis is not expected to affect the pharmacokinetics of this drug.

Other Comments

April 5, 2022: Due to the high frequency of circulating SARS-CoV-2 variants that are nonsusceptible to this drug, sotrovimab 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 should be administered by a qualified health care professional and administered only in settings which 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 IV infusion via infusion pump or gravity.
• Use a polyvinyl chloride (PVC) or polyolefin (PO) infusion set; use of a 0.2-micron polyethersulfone (PES) filter is strongly recommended.
• Attach the infusion set to the IV bag using standard bore tubing.
• Administer the entire infusion over 15 minutes for 50-mL infusion bag or 30 minutes for 100-mL infusion bag; do not administer as an IV push or bolus.
• Due to potential overfill of prefilled saline bags, administer the entire infusion solution in the bag to avoid underdosage.
• Do not administer the prepared (diluted) infusion solution simultaneously with any other medication.
• After infusion is complete, flush the tubing with 0.9% Sodium Chloride or 5% Dextrose to ensure the required dose has been delivered.
• Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete.

Storage requirements:

• Unopened vials: Store in refrigerator at 2C to 8C (36F to 46F) in original carton; protect from light and do not freeze or shake.
• Remove vial from refrigerated storage and allow to equilibrate to room temperature, protected from light, for about 15 minutes; do not shake the vial.
• Prepared (i.e., diluted) infusion solution: Should administer immediately; if immediate administration is not possible, store up to 24 hours refrigerated (2C to 8C [36F to 46F]) or up to 6 hours at room temperature (up to 25C [up to 77F]), including transportation and infusion time. If refrigerated, allow to equilibrate to room temperature for about 15 minutes prior to administration.

Reconstitution/preparation techniques:

• The infusion solution should be prepared by a qualified health care professional.
• This drug is available as a concentrated solution and must be diluted prior to IV administration; withdraw the specified volume from 1 single-dose vial and inject into a prefilled infusion bag.
• Use a PVC or PO, sterile, prefilled 50-mL or 100-mL infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose Injection.
• The Fact Sheet for Health Care Providers should be consulted.

IV compatibility:

• Compatible: 0.9% Sodium Chloride Injection, 5% Dextrose Injection
• Compatibility with other IV solutions and medications is not known.

General:

• Limitations of Authorized Use:
• This drug is not authorized for treatment of mild to moderate COVID-19 when 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.
• 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 patients on chronic oxygen.
• Benefit of therapy with this drug has not been seen in patients hospitalized due to COVID-19; SARS-CoV-2 monoclonal antibodies 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 FDA will monitor conditions to determine whether the use of this drug is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and the US CDC national and/or regional variant frequency data (https://covid.cdc.gov/covid-data-tracker/#variant-proportions).
• For medical conditions or other factors that may place patients at higher risk for progression to severe COVID-19, the US CDC website (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) should be consulted.
• The Fact Sheet for Health Care Providers should be consulted regarding approved available alternatives.
• ClinicalTrials.gov should be consulted for information on clinical trials testing this drug in COVID-19.

Patient advice:

• Read the Fact Sheet for Patients and Parents/Caregivers.
• Notify health care provider immediately if signs/symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur. Hypersensitivity reactions have occurred more than 24 hours after the infusion; notify health care provider immediately if signs/symptoms of hypersensitivity occur.
• There is a pregnancy registry that monitors pregnancy outcomes in patients exposed to this drug during pregnancy; pregnant and recently pregnant patients can enroll at covid-pr.pregistry.com or call 1-800-616-3791 for information about the registry.