Sotrovimab (Investigational)

COVID-19 (EUA), (EUA) issued by the FDA for treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients aged ≥12 years who weigh ≥40 kg with positive results of direct 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.

Intravenous 500 mg as a single IV infusion Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset in patients at high risk for progressing to severe COVID-19 and/or hospitalization. Hepatic impairment Not studied; pharmacokinetics unknown

Intravenous >12 years and weight >40 kg 500 mg as a single IV infusion Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 10 days of symptom onset in patients at high risk for progressing to severe COVID-19 and/or hospitalization

Renal impairment Mild, moderate, or severe: No dose adjustment required

IV Preparation Remove 1 vial of sotrovimab from refrigerated storage and allow to equilibrate to room temperature, protected from light, for ~15 minutes. Inspect for particulate matter and discoloration; solution should appear clear, colorless, or yellow to brown Gently swirl vial several times before use without creating air bubbles; do not shake vial Dilution Withdraw 8 mL of sotrovimab from one vial and inject into the prefilled 50-mL or 100-mL infusion bag containing 0.9% NaCl Discard any product remaining in vials Before infusion, gently rock infusion bag back and forth by hand 3-5 times; do not invert infusion bag; avoid forming air bubbles Administer immediately after preparation; if unable to administer immediately, store according to directions IV Administration If solution refrigerated, allow to equilibrate to room temperature for ~20 minutes Administer IV via pump or gravity according to size of infusion bag used Infuse by polyvinyl chloride (PVC) or polyolefin (PO) infusion set, and use of a 0.2-micron polyethersulfone (PES) filter is strongly recommended Attach infusion set to IV bag and prime infusion set Infuse over 30 min; do not administer IV push or bolus Owing to potential overfill of prefilled saline bags, administer entire infusion solution in bag to avoid underdosage Flush line with 0.9% NaCl after infusion completed to ensure entire dose delivered Discard unused product Monitor during infusion and observe patients for at least 1 hr after infusion completed Clinically monitor patients during infusion and observe patients for at least 1 hr after infusion is complete

None

Hypersensitivity Severe COVID-19 Treatment benefit not observed in patients hospitalized with COVID-19 Monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation Therefore, use is not authorized for use in patients Who are hospitalized with COVID-19, OR Who require oxygen therapy for COVID-19, OR Who require an increase in baseline oxygen flow rate because of COVID-19 (in those on long-term oxygen therapy for underlying non-COVID-19–related comorbidity)

Not Classi Pregnancy Insufficient data to evaluate drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes Use during pregnancy only if the potential benefit outweighs the potential risk for the mother and fetus No dosage adjustment recommended by the manufacturer Nonclinical reproductive toxicity studies have not been conducted Sotrovimab is an Fc-enhanced human IgG and may have the potential for placental transfer from mother to developing fetus Lactation Data are unknown regarding presence in human or animal milk, effects on breastfed infants, or effects on milk production Maternal IgG is known to be present in human milk No dosage adjustment recommended by the manufacturer

Recombinant human IgG1-kappa monoclonal antibody Binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2 with a dissociation constant KD = 0.21 nM) but does not compete with human ACE2 receptor binding (IC50 value >33.6 nM [5 mcg/mL]) Inhibits an undefined step that occurs after virus attachment and before fusion of the viral and cell membranes