Bebtelovimab

by Douglas Black, Pharm.D. last updated 2022-12-01 08:36:55.980001-05:00 © Antimicrobial Therapy, Inc.

Usage and Dosing

  • NOTE: as of November 30, 2022, bebtelovimab is not currently authorized for emergency use in any US region because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.
  • Bebtelovimab is a recombinant human IgG1k monoclonal antibody that binds to the spike protein of SARS-CoV-2.
  • EUA issued on February 11, 2022 for the treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years of age, weight ≥40 kg) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate. 
  • Retains activity against the omicron variant and the BA.2 omicron subvariant.
  • Not authorized for patients who are hospitalized due to COVID-19 or require oxygen therapy due to COVID-19.
  • Administer only 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.

Adult Dose

  • 175 mg IV (single dose).
  • Administer over at least 30 seconds.
  • Monitor patients for possible infusion-related reactions during administration, and observe patients for at least 1 hour after infusion is complete.
  • Administer ASAP after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset.

Pediatric Dose

  • ≥12 years of age, weight ≥40 kg: same dosing as adults.

Renal Adjustment

  • No dosage adjustment recommended in patients with any degree of renal impairment.
  • Dialysis is not expected to affect the pharmacokinetics of bebtelovimab.

Hepatic Adjustment

  • No dosage adjustment in patients with mild hepatic impairment.
  • Not studied in patients with moderate or severe hepatic impairment.

Adverse Effects

  • Infusion-related reactions. Signs and symptoms include fever, difficulty breathing, reduced O2 saturation, chills, fatigue, arrhythmia, chest pain or discomfort, weakness, altered mental status, nausea, headache, bronchospasm, hypotension, hypertension, angioedema, throat irritation, rash, pruritus, myalgia, vasovagal reactions, dizziness, and diaphoresis. Reactions may be severe or life-threatening.
  • Severe hypersensitivity reactions, including anaphylaxis.

Pharmacology

Class IgG1k monoclonal antibody
PK/PD Index  No data
Pharmaceutical
Preparation
 Injection
(175 mg/2 mL single-dose vials)
Usual Adult Dose  175 mg IV single-dose
Pregnancy Risk Summary
 No human or animal data
Food Effect1  -
Oral
Absorption2 (%)		  -
Peak Serum Level3
(μg/mL)		  59.8
Protein Binding
(%)		  no data
Average Serum
Half-life4		  11.5 days
Elimination
Catabolized into small peptides and amino acids
Biliary Penetration5 (%)  No data
CSF/Blood
Penetration6 (%)		  No data
Therapeutic Levels in CSF7  No data
Volume of Distribution8 4.61 L (Vss)
AUC0-inf9
(µg*day/mL)
 522
CYP450, Transporter Interactions
 None known
  •  Notes:
    • 1 Adult preparations unless otherwise noted.
    • 2 Oral 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

Major Drug Interactions

  • Not renally excreted or metabolized by CYP450 enzymes. Therefore, interactions with concomitant medications that are renally excreted or that are substrates, inducers, or inhibitors of CYP450 enzymes are unlikely.