Skip to main content
U.S. flag

An official website of the United States government

Dot gov

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Https

Secure .gov websites use HTTPS
A lock () or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products

Last Updated: December 16, 2021

  • The information in this table is based on data from investigational trials evaluating these products for the treatment or prevention of COVID-19. The table includes dose recommendations from the FDA EUAs for patients who meet specified criteria.
  • There are limited or no data on dose modifications for patients with organ failure or those who require extracorporeal devices. Please refer to product labels, when available.
  • There are currently not enough data to determine whether certain medications can be safely coadministered with therapies for the treatment or prevention of COVID-19. When using concomitant medications with similar toxicity profiles, consider performing additional safety monitoring.
  • The potential additive, antagonistic, or synergistic effects and the safety of using combination therapies for the treatment or prevention of COVID-19 are unknown. Clinicians are encouraged to report AEs to the FDA Medwatch program.
  • For drug interaction information, please refer to product labels and visit the Liverpool COVID-19 Drug Interactions website.
  • For the Panel’s recommendations on using the drugs listed in this table, please refer to the Anti-SARS-CoV-2 Monoclonal Antibodies, Therapeutic Management of Nonhospitalized Adults With COVID-19, and Prevention of SARS-CoV-2 Infection sections of the Guidelines.
Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products
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)
Authorized for the treatment or PEP of COVID-19 under FDA EUA.
Dose Recommended in EUA for Treatment and PEP of COVID-19 in Adults and Pediatric Patients Weighing ≥40 kg:
  • BAM 700 mg plus ETE 1,400 mg as a single IV infusion
Doses Recommended in EUA for Treatment and PEP of COVID-19 in Neonates, Infants, Children, and Adolescents Weighing <40 kg:
  • 1–12 kg: BAM 12 mg/kg plus ETE 24 mg/kg as a single IV infusion
  • >12 kg to 20 kg: BAM 175 mg plus ETE 350 mg as a single IV infusion
  • >20 kg to <40 kg: BAM 350 mg plus ETE 700 mg 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 ≥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)
Authorized for the treatment or PEP of COVID-19 under FDA EUA.

Dose Recommended in EUA for Treatment and PEP of COVID-19 in Adults and Pediatric Patients Aged ≥12 Years and Weighing ≥40 kg:

  • CAS 600 mg plus IMD 600 mg 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 for Individuals With Ongoing Exposure to SARS-CoV-2:

  • After initial dose, 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 in multiple trials in which participants received CAS 600 mg plus IMD 600 mg or higher doses of each drug.
  • 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 to treat severe infusion reactions.
  • Monitor patient during the IV infusion or SQ injections and for ≥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)
Authorized for the treatment of COVID-19 under FDA EUA.
Dose Recommended in EUA for Treatment of COVID-19 in Adults and Pediatric Patients Aged ≥12 Years and Weighing ≥40 kg:
  • 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 to treat severe infusion reactions.
  • Monitor patient during the IV infusion and for ≥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:

  • Under the FDA EUA, SOT is available 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
Authorized for the treatment of COVID-19 under FDA EUA.
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 use COVID-19 CP for the treatment of COVID-19 in patients aged <18 years should be based on an individualized assessment of risk and benefit.5
  • In patients with impaired cardiac function and heart failure, it may be necessary to reduce the CP volume or decrease the transfusion rate.

Availability:

SARS-CoV-2-Specific Immunoglobulin
Not approved by the FDA and not recommended by the Panel for the treatment of COVID-19. Currently under investigation in clinical trials.

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.

References

  1. Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization (EUA) of bamlanivimab and etesevimab. 2021. Available at: https://www.fda.gov/media/145802/download.
  2. Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization (EUA) of REGEN-COV (casirivimab and imdevimab). 2021. Available at: https://www.fda.gov/media/145611/download.
  3. Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization (EUA) of sotrovimab. 2021. Available at: https://www.fda.gov/media/149534/download.
  4. Marano G, Vaglio S, Pupella S, et al. Convalescent plasma: new evidence for an old therapeutic tool? Blood Transfus. 2016;14(2):152-157. Available at: https://www.ncbi.nlm.nih.gov/pubmed/26674811.
  5. Food and Drug Administration. EUA of COVID-19 convalescent plasma for the treatment of COVID-19 in hospitalized patients: fact sheet for health care providers. 2020. Available at: https://www.fda.gov/media/141478/download.
  6. Food and Drug Administration. Convalescent plasma letter of authorization. 2020. Available at: https://www.fda.gov/media/141477/download.