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

Last Updated: October 19, 2021

Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products Under Evaluation for the Treatment of COVID-19
Dosing Regimens Adverse Events 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 for Treatment and PEP of COVID-19:
  • BAM 700 mg plus ETE 1,400 mg administered together as a single IV infusion
  • Nausea
  • Dizziness
  • Pruritis
  • Hypersensitivity, including anaphylaxis and infusion-related reactions
  • These AEs were observed in multiple trials in which participants received either the authorized doses of BAM and ETE or higher doses of each drug.
  • Only for administration in health care settings by qualified health care providers who have immediate access to emergency medical services and medications to treat severe infusion reactions.
  • Monitor patient during the IV infusion and for at least 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:

  • The distribution of BAM plus ETE in the United States was paused in June 2021 because the Gamma (P.1) and Beta (B.1.351) variants have reduced susceptibility to BAM and ETE. Distribution of BAM plus ETE was resumed in August 2021.
  • For updates on the distribution of BAM plus ETE, see this FDA document.
  • BAM plus ETE is available through the FDA EUA as treatment for high-risk outpatients with mild to moderate COVID-19 and as PEP for certain high-risk patients.1 See Anti-SARS-CoV-2 Monoclonal Antibodies and Prevention of SARS-CoV-2 Infection for a list of high-risk conditions and criteria for use of BAM plus ETE.
  • A list of clinical trials is available: Bamlanivimab Plus Etesevimab
Casirivimab Plus Imdevimab (Anti-SARS-CoV-2 Monoclonal Antibodies)

Dose Recommended in EUA for Treatment of COVID-19:

  • CAS 600 mg plus IMD 600 mg administered together as a single IV infusion over 1 hour.
  • IV infusion is the preferred route of administration. However, when IV infusion is not feasible or would delay treatment, CAS 600 mg plus IMD 600 mg can be administered as 4 SQ injections (2.5 mL per injection) at 4 different sites. See the FDA EUA for detailed information.

Dose Recommended in EUA for PEP of COVID-19:

  • CAS 600 mg plus IMD 600 mg administered by SQ injections or IV infusion
  • For individuals with ongoing exposure to SARS-CoV-2, repeat dosing of CAS 300 mg plus IMD 300 mg by SQ injections or IV infusion every 4 weeks for duration of ongoing exposure.
  • Hypersensitivity, including anaphylaxis and infusion-related reactions
  • These AEs were observed over multiple trials where participants received CAS 600 mg plus IMD 600 mg or higher doses.
  • Injection site reactions, including ecchymosis and erythema, in clinical trial participants who received CAS plus IMD administered by SQ injections.
  • Only for administration in health care settings by qualified health care providers who have immediate access to emergency medical services and medications that treat severe infusion reactions.
  • Monitor patient during the IV infusion or SQ injections and for at least 1 hour after the infusion or injections are 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:

Sotrovimab (Anti-SARS-CoV-2 Monoclonal Antibody)
Dose Recommended in EUA for Treatment of COVID-19:
  • SOT 500 mg administered by IV infusion over 30 minutes
  • Rash
  • Diarrhea
  • Hypersensitivity, including anaphylaxis and infusion-related reactions
  • Only for administration in health care settings by qualified health care providers who have immediate access to emergency medical services and medications that treat severe infusion reactions.
  • Monitor patient during the IV infusion and for at least 1 hour after the infusion is completed.
  • Drug-drug interactions are unlikely between SOT and medications that are renally excreted or that are CYP substrates, inhibitors, or inducers.

Availability:

  • SOT is available through the FDA EUA for the treatment of high-risk outpatients with mild to moderate COVID-19.3 See Anti-SARS-CoV-2 Monoclonal Antibodies for a list of high-risk conditions.
  • A list of clinical trials is available: Sotrovimab
COVID-19 Convalescent Plasma
Dose Recommended in EUA for Treatment of 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 infections4
  • 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.5
  • Patients with impaired cardiac function and heart failure may require a smaller volume of CP or a slower transfusion rate.

Availability:

SARS-CoV-2-Specific Immunoglobulin

Dose in Clinical Trials for Treatment of COVID-19:

  • Dose varies by clinical trial
  • TRALI
  • TACO
  • Allergic reactions
  • Antibody-mediated enhancement of infection
  • RBC alloimmunization
  • Transfusion-transmitted infections4
  • 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.