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Sotrovimab Dosage

Medically reviewed by Drugs.com. Last updated on Apr 18, 2022.

Applies to the following strengths: 500 mg/8 mL

Usual Adult Dose for:

Usual Pediatric Dose for:

Additional dosage information:

Usual Adult Dose for COVID-19

For investigational use only

500 mg IV as a single dose

Comments:

The US FDA issued an Emergency Use Authorization (EUA) to allow the emergency use of the unapproved drug 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 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 use.April 5, 2022: Due to the high frequency of the Omicron BA.2 sub-variant, this drug 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.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 product 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.This drug should be administered as soon as possible after positive SARS-CoV-2 viral test 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 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 US FDA issued an EUA to allow the emergency use of the unapproved drug sotrovimab 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; this drug is not approved by the US FDA for this use.April 5, 2022: Due to the high frequency of the Omicron BA.2 sub-variant, this drug 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.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 product 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.This drug should be administered as soon as possible after positive SARS-CoV-2 viral test 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 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 effect the pharmacokinetics of this drug.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

  • This EUA is for the use of the unapproved drug sotrovimab to treat 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.
  • For additional information on all products authorized for treatment or prevention of COVID-19: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
  • This drug must be administered after dilution by IV infusion; it 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.
  • The prescribing health care provider and/or the provider's designee is/are responsible for mandatory reporting of all SERIOUS ADVERSE EVENTS and MEDICATION ERRORS potentially related to this drug within 7 calendar days from health care provider's awareness of the event; the Fact Sheet for Health Care Providers should be consulted for reporting requirements.
  • The authorized dosage may be updated as additional clinical trial data become available.
  • ClinicalTrials.gov should be consulted for information on clinical trials testing this drug in COVID-19.

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 effect the pharmacokinetics of this drug.

Other Comments

April 5, 2022: Due to the high frequency of the Omicron BA.2 sub-variant, this drug 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:

The infusion solution should be administered by a qualified health care professional.Administer the entire infusion solution in the bag via IV 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.Use a polyvinyl chloride (PVC) or polyolefin (PO) infusion set; use of a 0.2-micron polyethersulfone (PES) filter is strongly recommended.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:
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).Medical Conditions or Other Factors That May Place Adults and Pediatric Patients (12 To 17 Years of Age and Weighing At Least 40 kg) At Higher Risk for Progression to Severe COVID-19:Older age (e.g., at least 65 years of age)Obesity or being overweight (e.g., adults with BMI greater than 25 kg/m2, or if 12 to 17 years of age, have BMI greater than or equal to the 85th percentile for their age and gender based on US CDC growth charts)PregnancyChronic kidney diseaseDiabetesImmunosuppressive disease or immunosuppressive therapyCardiovascular disease (including congenital heart disease) or hypertensionChronic lung diseases (e.g., chronic obstructive pulmonary disease, asthma [moderate-to-severe], interstitial lung disease, cystic fibrosis, pulmonary hypertension)Sickle cell diseaseNeurodevelopmental disorders (e.g., cerebral palsy) or other conditions that confer medical complexity (e.g., genetic/metabolic syndromes, severe congenital anomalies)Having a medical-related technological dependence (e.g., tracheostomy, gastrostomy, positive pressure ventilation [not related to COVID-19])Other medical conditions or factors (e.g., race, ethnicity) may also place individual patients at high risk for progression to severe COVID-19 and authorization of this drug under the EUA is not limited to the medical conditions or factors listed above; the US CDC website (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html) should be consulted for additional information. The benefit-risk should be considered for each patient.The Fact Sheet for Health Care Providers should be consulted regarding approved available alternatives.

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.
  • 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.

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