Bamlanivimab

by Douglas Black, Pharm.D. last updated 2020-11-24 13:00:46.225782-05:00 © Antimicrobial Therapy, Inc.
  • Bamlanivimab (Lilly) is a neutralizing IgG1 monoclonal antibody that binds to the receptor binding domain of the spike protein of SARS-CoV-2. It is indicated for treatment of mild to moderate COVID-19 in adults and children (age ≥12 yrs and wt ≥40 kg) who are at risk for severe disease or hospitalization.
  • Early Use Authorization by FDA issued 10 Nov 2020; (Prescribing information here). Specifically, EUA issued for those who are defined as high risk (defined as patients who meet at least one of the following criteria:
    • Body mass index (BMI) ≥35
    • Chronic kidney disease
    • Diabetes
    • Immunosuppressive disease
    • Age ≥65 years
    • Age ≥55 years and at least one of the following:
      • Cardiovascular disease
      • Hypertension
      • Chronic obstructive pulmonary disease/other chronic respiratory disease
    • Age 12-17 years and at least one of the following:
      • BMI ≥85th percentile for their age and gender based on CDC growth
      • Sickle cell disease
      • Congenital or acquired heart disease
      • Medical-related technological dependence, for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID-19)
      • Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control
  • 700 mg as a single IV infusion.
  • Administer in 200 mL of normal saline over one hour through an IV line with a 0.2 micron polyethersulfone filter (withdraw 70 mL from a 250 mL bag, then add the drug).
  • Administer the diluted infusion solution immediately. If this is not possible, the diluted solution may be stored in the refrigerator (2-8ºC) for up to 24 hours, or at room temperature (20-25ºC) for up to seven hours (including infusion time).
  • ≥12 years of age, weight ≥40 kg: same as adult dose.
  • No adjustment recommended.
  • No adjustment recommended in mild hepatic impairment.
  • Not studied in patients with moderate or severe impairment.
  • Monitor patients during infusion and for at least one hour after infusion is complete.
  • Infusion-related adverse effects:
    • Fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash including urticaria, pruritus, myalgia, dizziness
  • Serious hypersensitivity reaction, including anaphylaxis.
 Class IgG1 mAb
PK/PD Index No data
Pharmaceutical
Preparation
Injection
Usual Dose 700 mg IV single infusion
Pregnancy
Category
No human data
Food Effect1 Not applicable
Oral
Absorption2 (%)
Not applicable
Mean Serum Level3
(μg/mL)
No data
Protein Binding
(%)
No data
Average Serum
Half-life4
Approx 24 hrs
Biliary Penetration5 (%) No data
CSF/Blood
Penetration6 (%)
No data
Therapeutic Levels in CSF7 No data
Volume of Distribution8
(Vd)
No data
AUC
(μg*DAY/mL)
No data
CYP450, Transporter
Interactions
No known interactions
  • 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
  • No clinically significant interactions known.
  • Product availability: 700 mg/20 mL in single-dose vials, preservative-free.
  • Storage: refrigerate unopened vials at 2-8°C, protected from light. Allow to equilibrate to room temperature for 20 minutes before preparation. Do not expose to direct heat.