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: Under the FDA EUA, BAM plus ETE is available 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) 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: Under the FDA EUA, CAS plus IMD is available as treatment for high-risk outpatients with mild to moderate COVID-19 and as PEP for certain high-risk individuals.² 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 CAS plus IMD. A list of clinical trials is available: Casirivimab Plus Imdevimab
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: Under the FDA EUA, high-titer COVID-19 CP is available for hospitalized patients with COVID-19.⁶ See Convalescent Plasma. A list of clinical trials is available: COVID-19 Convalescent Plasma
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.	A list of clinical trials is available: SARS-CoV-2 Immunoglobulin
Key: AE = adverse event; BAM = bamlanivimab; CAS = casirivimab; CP = convalescent plasma; CYP = cytochrome P450; ETE = etesevimab; EUA = Emergency Use Authorization; FDA = Food and Drug Administration; IMD = imdevimab; IV = intravenous; the Panel = the COVID-19 Treatment Guidelines Panel; PEP = post-exposure prophylaxis; RBC = red blood cell; SOT = sotrovimab; SQ = subcutaneous; TACO = transfusion-associated circulatory overload; TRALI = transfusion-related acute lung injury

References

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.
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.
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.
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.
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.
Food and Drug Administration. Convalescent plasma letter of authorization. 2020. Available at: https://www.fda.gov/media/141477/download.