Sotrovimab

by Editorial Board last updated 2021-05-29 15:55:15.337062-04:00
  • Sotrovimab is a recombinant human IgG1-kappa monoclonal antibody that binds to a conserved epitope on the spike protein receptor binding domain of SARS-CoV-2.
  • Early Use Authorization (EUA) issued by US FDA on May 26, 2021 for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (≥12 years of age, weight ≥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.
  • Risk factors for progression to severe COVID-19:
    • Age ≥65 years
    • Obesity
    • Pregnancy
    • Chronic kidney disease
    • Diabetes
    • Immunosuppression
    • Cardiovascular disease, hypertension
    • Chronic lung disease
    • Sickle-cell disease
    • Neurodevelopmental disorders
    • Having a medical-related technological dependence (e.g. tracheostomy)
  • Not authorized for use in patients:
    • who are hospitalized due to COVID-19
    • who require oxygen therapy due to COVID-19
    • who require an increase in baseline oxygen flow rate due to COVID-19
  • 500 mg IV infused over 30 minutes (single infusion)
  • Preparation:
    • Allow vial to equilibrate to room temperature (approximately 15 minutes).
    • Gently swirl vial, do not shake.
    • Withdraw 8 mL (500 mg), add to 50 mL or 100 mL normal saline infusion bag. Rock infusion bag back and forth, do not invert bag, avoid forming air bubbles.
    • Administer within four hours if at room temperature (24 hours if refrigerated). Use of a 0.2 micron polyethersulfone filter is strongly recommended.
  • Age ≥12 years, weight ≥40kg: 500 mg IV infused over 30 minutes (single infusion)
  • No dosage adjustment recommended
  • The effect of hepatic impairment on sotrovimab pharmacokinetics is unknown.
  • Clinically monitor patients during infusion, and observe for at least one hour after infusion is complete.
  • Hypersensitivity reactions, including anaphylaxis.
  • Infusion-related reactions:
    • Fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g., atrial
      fibrillation, sinus tachycardia, bradycardia), chest pain or discomfort, weakness, altered
      mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema,
      throat irritation, rash including urticaria, pruritus, myalgia, vasovagal reactions (e.g., pre-
      syncope, syncope), dizziness, and diaphoresis.
  • Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, tachycardia, bradycardia), fatigue, and altered mental status.
Class IgG monoclonal antibody
PK/PD Index No data
Pharmaceutical
Preparation
 Injection
(500 mg/8 mL vials)
Usual Adult Dose  500 mg IV over 30 min
Pregnancy Risk Summary
 Human, animal: no data
Food Effect1  N/A
Oral
Absorption2 (%)
 N/A
Peak Serum Level3
(μg/mL)
 137 (500 mg SD)
Protein Binding
(%)
 No data
Average Serum
Half-life4 (hr)
No data
(prolonged)
Biliary Penetration5 (%)  No data
CSF/Blood
Penetration6 (%)
 No data
Therapeutic Levels in CSF7  No data
Volume of Distribution8
(Vd)
 No data
AUC9
(μg*hr/mL)
 No data
CYP450, Transporter
Interactions
 None
  • Notes:
    • 1 Adult preparations unless otherwise noted.
    • 2 Absorption under optimal conditions.
    • 3 Total drug; adjust for protein binding to determine free drug concentration.
      • SD = after single dose
      • SS = steady state after multiple doses
    • 4 Assumes CrCl > 80 mL/min
    • 5 Peak concentration in bile/peak concentration in serum x 100
    • 6 CSF levels with inflammation
    • 7 Judgment based on drug dose & organism susceptibility. CSF concentration ideally ≥10x above MIC.
    • 8 Volume of Distribution (Vd):
      • V/F = Vd/oral bioavailability
      • Vss = Vd at steady state
      • Vss/F = Vd at steady state/oral bioavailability
    • 9 Area under the plasma concentration versus time curve
  • Clinical drug-drug interaction studies have not been performed.
  • Interactions with medications that are renally excreted or that are substrates, inducers, or inhibitors of CYP450 enzymes are unlikely.
  • Product storage
    • Refrigerate unopened vials (2-8°C).
    • Sotrovimab is preservative-free.