Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products Under Evaluation for the Treatment of COVID-19

Last Updated: April 21, 2021

Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products Under Evaluation for the Treatment of COVID-19
Dosing Regimens Adverse Effects Monitoring Parameters Drug-Drug Interaction Potential Comments and Links to Clinical Trials
Bamlanivimab Plus Etesevimab (Anti-SARS-CoV-2 Monoclonal Antibodies)

Dose Recommended in EUA:

  • BAM 700 mg and ETE 1,400 mg IV administered together as a single dose
  • Nausea
  • Dizziness
  • Rash
  • Pruritis
  • Pyrexia
  • Hypersensitivity, including anaphylaxis and infusion-related reactions
  • Unexpected SAEs may occur.
  • These AEs were observed in a trial where the doses of BAM and ETE given (BAM 2,800 mg and ETE 2,800 mg) were higher than the EUA doses.
  • Only for administration in health care settings by qualified health care providers who have immediate access to medications to treat a severe infusion reaction and emergency medical services.
  • Monitor patient during the infusion and for ≥1 hour after the infusion is completed.
  • Drug-drug interactions are unlikely between BAM plus ETE and medications that are renally excreted or that are CYP substrates, inhibitors, or inducers.

Availability:

Casirivimab Plus Imdevimab (Anti-SARS-CoV-2 Monoclonal Antibodies)
Dose Recommended in EUA:
  • CAS 1,200 mg and IMD 1,200 mg IV administered together as a single dose
  • Hypersensitivity, including anaphylaxis and infusion-related reactions
  • Unexpected SAEs may occur.
  • Only for administration in health care settings by qualified health care providers who have immediate access to medications to treat a severe infusion reaction and emergency medical services.
  • Monitor patient during the infusion and for ≥1 hour after the infusion is completed.
  • Drug-drug interactions are unlikely between CAS plus IMD and medications that are renally excreted or that are CYP substrates, inhibitors, or inducers.

Availability:

COVID-19 Convalescent Plasma
Dose Recommended in EUA Authorizing the Use of High-Titer COVID-19 CP for Hospitalized Patients With COVID-19:
  • Per the EUA, consider starting clinical dosing with 1 high-titer COVID-19 CP unit (about 200 mL), with administration of additional CP units based on the prescribing provider’s medical judgment and the patient’s clinical response.
  • TRALI
  • TACO
  • Allergic reactions
  • Anaphylactic reactions
  • Febrile nonhemolytic reactions
  • Hemolytic reactions
  • Hypothermia
  • Metabolic complications
  • Transfusion-transmitted infections3
  • Thrombotic events
  • Theoretical risk of antibody-mediated enhancement of infection and suppressed long-term immunity
  • Before administering CP to patients with a history of severe allergic or anaphylactic transfusion reactions, the Panel recommends consulting a transfusion medicine specialist who is associated with the hospital blood bank.
  • Monitor for transfusion-related reactions.
  • Monitor patient’s vital signs at baseline and during and after transfusion.
  • Drug products should not be added to the IV infusion line for the blood product.
  • The decision to treat patients aged <18 years with COVID-19 CP should be based on an individualized assessment of risk and benefit.4
  • Patients with impaired cardiac function and heart failure may require a smaller volume of CP or slower transfusion rate.

Availability:

SARS-CoV-2-Specific Immunoglobulin
Dose varies by clinical trial
  • TRALI
  • TACO
  • Allergic reactions
  • Antibody-mediated enhancement of infection
  • RBC alloimmunization
  • Transfusion-transmitted infections3
  • Monitor for transfusion-related reactions.
  • Monitor patient’s vital signs at baseline and during and after transfusion.
  • Drug products should not be added to the IV infusion line for the blood product.