IV Dilution &
Medication Reference

Sotrovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to these drugs and regional variant frequency.

•FDA's determination and any updates will be available at: HTTPS://WWW.FDA.GOV/EMERGENCY-PREPAREDNESS-AND-RESPONSE/MCM-LEGAL-REGULATORY-AND-POLICY-FRAMEWORK/EMERGENCY-USE-AUTHORIZATION#COVIDDRUGS. 1

Sotrovimab is not authorized for use in the following patient populations:
• Adults or pediatric patients who are hospitalized due to COVID-19, OR
•Adults or pediatric patients who require oxygen therapy and/or respiratory support due to COVID-19, OR
•Adults or pediatric patients 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 treatment with sotrovimab has not been observed 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 requiring high flow oxygen or mechanical ventilation.

RECENT MAJOR CHANGES

Sotrovimab has been authorized by FDA for the emergency use described above.

Sotrovimab is not FDA-approved for this use.

Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

1

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 [see Microbiology/Resistance Information (15)], and CDC regional variant frequency data available at: HTTPS://COVID.CDC.GOV/COVID-DATA-TRACKER/#VARIANT-PROPORTIONS.

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 [see LIMITATIONS OF AUTHORIZED USE].

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:
a. Given the "Fact Sheet for Patients, Parents, and Caregivers",
b. Informed of alternatives to receiving authorized sotrovimab, and
c. Informed that sotrovimab is an unapproved drug that is authorized for use under this Emergency Use Authorization.

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 responsible for mandatory reporting of all serious adverse events* and medication errors potentially related to sotrovimab within 7 calendar days from the healthcare provider's awareness of the event, using FDA Form 3500 (for information on how to access this form, see below). The FDA requires that such reports, using FDA Form 3500, include the following:

•

Patient demographics and baseline characteristics (e.g., patient identifier, age or date of birth, gender, weight, ethnicity, and race)

•

A statement "Sotrovimab use for COVID-19 under Emergency Use Authorization (EUA)" under the "Describe Event, Problem, or Product Use/Medication Error" heading

•

Information about the serious adverse event or medication error (e.g., signs and symptoms, test/laboratory data, complications, timing of drug initiation in relation to the occurrence of the event, duration of the event, treatments required to mitigate the event, evidence of event improvement/disappearance after stopping or reducing the dosage, evidence of event reappearance after reintroduction, clinical outcomes)

•

Patient's preexisting medical conditions and use of concomitant products

•

Information about the product (e.g., dosage, route of administration, NDC #)

5.

Submit adverse event and medication error reports, using Form 3500, to FDA MedWatch using one of the following methods:

•

Complete and submit the report online: WWW.FDA.GOV/MEDWATCH/REPORT.HTM

•

Complete and submit a postage-paid FDA Form 3500 (HTTPS://WWW.FDA.GOV/MEDIA/76299/DOWNLOAD) and return by:

o

Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787, or

o

Fax to 1-800-FDA-0178, or

•

Call 1-800-FDA-1088 to request a reporting form

•

In addition, please provide a copy of all FDA MedWatch forms to:

GlaxoSmithKline, Global Safety

Fax: 919-287-2902

Email: [email protected]

Or call the GSK COVID Contact Center at 1-866-GSK-COVID (866-475-2684) to report

adverse events.

6.

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.

*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;

•other important medical event, which may require a medical or surgical intervention to prevent death, a life-threatening event, hospitalization, disability, or congenital anomaly.

7.

OTHER REPORTING REQUIREMENTS

•Healthcare facilities and providers will report therapeutics information and utilization data as directed by the U.S. Department of Health and Human Services.

Sotrovimab should be administered as soon as possible after a positive viral test for SARS-CoV-2 and within 7 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 [see Authorized Use (1) and Clinical Trial Results and Supporting Data for EUA (18)].

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, HTTPS://WWW.CDC.GOV/GROWTHCHARTS/CLINICAL_CHARTS.HTM)

•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: HTTPS://WWW.CDC.GOV/CORONAVIRUS/2019-NCOV/NEED-EXTRA-PRECAUTIONS/PEOPLE-WITH-MEDICAL-CONDITIONS.HTML

Healthcare providers should consider the benefit-risk for an individual patient.

The dosage in adults and pediatric patients (12 years of age and older weighing at least 40 kg) is 500 mg of sotrovimab administered as a single IV infusion. Sotrovimab should be given as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.

•Sotrovimab is available as a concentrated solution and must be diluted prior to IV infusion.

•Administer 500 mg of sotrovimab by IV infusion over 15 minutes for 50-mL infusion bag or 30 minutes for 100-mL infusion bag.

•Clinically monitor patients during infusion and observe patients for at least 1 hour after infusion is complete.

Pregnancy or Lactation

No dosage adjustment is recommended in pregnant or lactating women [see Use in Specific Populations (11.1, 11.2)].

Pediatric Use

No dosage adjustment is recommended in pediatric patients who weigh at least 40 kg and are 12 years of age and older. Sotrovimab is not authorized for patients under 12 years of age or pediatric patients weighing less than 40 kg [see Use in Specific Populations (11.3)].

Geriatric Use

No dosage adjustment is recommended in geriatric patients [see Use in Specific Populations (11.4)].

Renal Impairment

No dosage adjustment is recommended in patients with renal impairment [see Use in Specific Populations (11.5)].

Preparation

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

Sotrovimab infusion solution should be prepared by a qualified healthcare professional using aseptic technique.

•Gather the materials for preparation:

•Polyvinyl chloride (PVC) or polyolefin (PO), sterile, prefilled 50-mL or 100-mL infusion bag containing 0.9% Sodium Chloride Injection or 5% Dextrose 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.

•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 6 hours at room temperature (up to 25°C [up 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 [see Warnings and Precautions (5.1)].

Sotrovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary [see Warnings and Precautions (5.1)].

•Gather the materials for infusion via infusion pump or gravity:

•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 15 minutes for 50-mL infusion bag or 30 minutes for 100-mL infusion bag. 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 and 5% Dextrose Injection is not known

•Once infusion is complete, flush the tubing with 0.9% Sodium Chloride or 5% Dextrose 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.