Sotrovimab Dosing and Administration

Learn more about sotrovimab dosing and administration. See the box below for a directory of the information featured on this page.

For more information, please access the Detailed Guide for the Use of Sotrovimab or contact 1-866-GSK-COVID (866-475-2684).

Patient Selection

Sotrovimab should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 10 days of symptom onset in adults and pediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death.

 

The following medical conditions or other factors may place adults and pediatric patients (12 to 17 years of age weighing at least 40 kg) at higher risk for progression to severe COVID-19:

  • Older age (for example, ≥65 years of age)
  • Obesity or being overweight (for example, adults with BMI >25 kg/m2, or if 12 to 17, have BMI ≥85th percentile for their age and gender based on CDC growth charts)
  • 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 sotrovimab 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 CDC website. Healthcare providers should consider the benefit-risk for an individual patient.

National Institutes of Health (NIH) COVID-19 Treatment Guidelines1

The NIH also recommends considering monoclonal antibodies when treating patients with mild-to-moderate COVID-19 who are hospitalized for a reason other than COVID-19 if they otherwise meet the EUA criteria for outpatient treatment. 

 

The NIH treatment guildelines change regularly. The complete, up-to-date guidelines can be found on the NIH website.

 

Dosage

The dosage of sotrovimab in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is a single IV infusion of 500 mg. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset.

 

Sotrovimab must be diluted and administered as a single intravenous infusion over 30 minutes.

 

Dosage Adjustment in Specific Populations

Pregnancy or Lactation

No dosage adjustment is recommended in pregnant or lactating women.

 

Pediatric Use

No dosage adjustment is recommended in pediatric patients who weigh at least 40 kg and are 12 years of age or older. Sotrovimab is not authorized for patients under 12 years of age or pediatric patients weighing less than 40 kg.

 

Geriatric Use

No dosage adjustment is recommended in geriatric patients.

 

Renal Impairment

No dosage adjustment is recommended in patients with renal impairment.

Preparation and Administration

Preparation

Sotrovimab is supplied in a single-dose vial and must be diluted prior to administration.

 

Sotrovimab injection should be prepared by a qualified healthcare professional using aseptic technique:

  • Gather the materials for preparation:
    • Polyvinyl chloride (PVC) or polyolefin (PO), sterile prefilled infusion bag. Choose one of the following sizes: prefilled 50-mL or 100-mL infusion bag containing 0.9% Sodium Chloride Injection, and
    • One vial of sotrovimab (500 mg/8 mL).
  • Remove one vial of sotrovimab from refrigerated storage and allow to equilibrate to room temperature, protected from light, for approximately 15 minutes.
  • Inspect the vial of sotrovimab visually for particulate matter and discoloration prior to administration. Should either be observed, the solution must be discarded and fresh solution prepared. Sotrovimab is a clear, colorless or yellow to brown solution.
  • Gently swirl the vial several times before use without creating air bubbles. Do not shake the vial.
  • Withdraw 8 mL of sotrovimab from one vial and inject into the prefilled infusion bag containing 0.9% Sodium Chloride Injection.
  • Discard any product remaining in the vial.
  • Prior to the infusion, gently rock the infusion bag back and forth by hand 3 to 5 times. Do not invert the infusion bag. Avoid forming air bubbles.
  • This product is preservative-free; therefore, the diluted infusion solution should be administered immediately. If immediate administration is not possible, store the diluted solution of sotrovimab up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]) or refrigerated up to 24 hours (2°C to 8°C [36°F to 46°F]).


Administration

Sotrovimab infusion solution should be administered by a qualified healthcare professional.

  • Gather the materials for infusion:
    • Polyvinyl chloride (PVC) or polyolefin (PO) infusion set, and
    • Use of a 0.2 micron polyethersulfone (PES) filter is strongly recommended.
  • Attach the infusion set to the IV bag using standard bore tubing.
  • Prime the infusion set.
  • Administer the entire infusion solution in the bag over 30 minutes. Due to potential overfill of prefilled saline bags, the entire infusion solution in the bag should be administered to avoid underdosage.
  • Do not administer as an IV push or bolus.
  • The prepared infusion solution should not be administered simultaneously with any other medication. The compatibility of sotrovimab with IV solutions and medications other than 0.9% Sodium Chloride Injection is not known.
  • Once infusion is complete, flush the tubing with 0.9% Sodium Chloride to ensure delivery of the required dose.
  • If the infusion must be discontinued due to an infusion reaction, discard unused product.
  • Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete.

Storage

This product is preservative-free; therefore, the diluted infusion solution should be administered immediately. If immediate administration is not possible, store the diluted infusion solution for up to 24 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]) or up to 4 hours at room temperature (20°C to 25°C [68°F to 77°F]), including transportation and infusion time. If refrigerated, allow the infusion solution to equilibrate to room temperature for approximately 15 minutes prior to administration.

INSTRUCTIONS FOR HEALTHCARE PROVIDERS

As the healthcare provider, you must communicate to your patient or parent/caregiver, as age appropriate, information consistent with the Fact Sheet for Patients, Parents and Caregivers (and provide a copy of the Fact Sheet) prior to the patient receiving sotrovimab, including:

 

  • The patient or parent/caregiver has the option to accept or refuse sotrovimab
  • The significant known and potential risks and benefits of sotrovimab and the extent to which such risks and benefits are unknown
  • Information on available alternative treatments and the risks and benefits of those alternatives, including clinical trials
  • Patients treated with sotrovimab should continue to self-isolate and use infection control measures (eg, wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect “high-touch” surfaces, and frequent handwashing) according to CDC guidelines

For information on clinical trials that are testing the use of sotrovimab for COVID-19, please see www.clinicaltrials.gov.

MANDATORY REQUIREMENTS FOR ADMINISTRATION OF SOTROVIMAB UNDER EMERGENCY USE AUTHORIZATION

In order to mitigate the risks of using this unapproved product under the EUA and to optimize the potential benefit of sotrovimab, the following steps are required. Use of sotrovimab under this EUA is limited to the following (all requirements must be met):

  1. Treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) 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.
  2. As the healthcare provider, communicate to your patient or parent/caregiver information consistent with the Fact Sheet for Patients, Parents and Caregivers prior to the patient receiving sotrovimab. Healthcare providers (to the extent practicable given the circumstances of the emergency) must document in the patient’s medical record that the patient/caregiver has been:
    1. given the Fact Sheet for Patients, Parents and Caregivers,
    2. informed of alternatives to receiving authorized sotrovimab, and
    3. informed that sotrovimab is an unapproved drug that is authorized for use under this EUA.
  3. Patients with known hypersensitivity to any ingredient of sotrovimab must not receive sotrovimab.
  4. The prescribing healthcare provider and/or the provider’s designee is/are also responsible for mandatory reporting of all medication errors and serious adverse events* potentially related to sotrovimab within 7 calendar days from the onset of the event. The reports should include unique identifiers and the words “Sotrovimab use for COVID-19 under Emergency Use Authorization (EUA)” in the description section of the report.
    • Submit adverse event reports to FDA MedWatch using one of the following methods:
      • Complete and submit the report online at www.fda.gov/medwatch/report.htm, or
      • Complete and submit a postage-paid FDA Form 3500 (https://www.fda.gov/media/76299/download) and return by:
        • Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or
        • Fax (1-800-FDA-0178), or
      • Call 1-800-FDA-1088 to request a reporting form
      • Submitted reports should include in the field name, “Describe Event, Problem, or Product Use/Medication Error” the statement “Sotrovimab use for COVID-19 under Emergency Use Authorization (EUA)”

    *Serious Adverse Events are defined as:

    • death;
    • a life-threatening adverse event;
    • inpatient hospitalization or prolongation of existing hospitalization;
    • a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions;
    • a congenital anomaly/birth defect;
    • a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.
  5. The prescribing healthcare provider and/or the provider’s designee is/are responsible for mandatory responses to requests from FDA for information about adverse events and medication errors following receipt of sotrovimab.
  6. OTHER REPORTING REQUIREMENTS
  • In addition, please provide a copy of all FDA MedWatch forms to:

    GlaxoSmithKline, Global Safety
    Fax: 919-287-2902
    Email: WW.GSKAEReportingUS@gsk.com
    Or call the GSK COVID Contact Center at 1866GSKCOVID (8664752684) to report adverse events.

Healthcare providers should review the Fact Sheet for information on the authorized use of sotrovimab and mandatory requirements of the EUA. Please see the FDA Letter of Authorization, Fact Sheet for Healthcare ProvidersFact Sheet for Patients, Parents and Caregivers (English), and Fact Sheet for Patients, Parents and Caregivers (Spanish)

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To learn more about COVID-19, visit the CDC and WHO websites.