Table 3c. Characteristics of SARS-CoV-2 Antibody-Based Products
Last Updated: April 8, 2022
- 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.
Dosing Regimens | Adverse Events | Monitoring Parameters | Drug-Drug Interaction Potential | Comments and Links to Clinical Trials |
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Bamlanivimab Plus Etesevimab (Anti-SARS-CoV-2 Monoclonal Antibodies) Authorized for the treatment and PEP of COVID-19 under FDA EUA, but distribution has paused because the Omicron VOC has markedly reduced in vitro susceptibility to BAM plus ETE. | ||||
Dose Recommended in FDA EUA for Treatment and PEP of COVID-19 in Adults and Pediatric Patients Weighing ≥40 kg:
Doses Recommended in FDA EUA for Treatment and PEP of COVID-19 in Neonates, Infants, Children, and Adolescents Weighing <40 kg:
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Bebtelovimab (Anti-SARS-CoV-2 Monoclonal Antibody) Authorized for the treatment of COVID-19 under FDA EUA. | ||||
Dose Recommended in FDA EUA for Treatment of COVID-19 in Adults and Pediatric Patients Aged ≥12 Years and Weighing ≥40 kg:
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Casirivimab Plus Imdevimab (Anti-SARS-CoV-2 Monoclonal Antibodies) Authorized for the treatment and PEP of COVID-19 under FDA EUA, but distribution has paused because the Omicron VOC has markedly reduced in vitro susceptibility to CAS plus IMD. | ||||
Dose Recommended in FDA EUA for Treatment and PEP of COVID-19 in Adults and Pediatric Patients Aged ≥12 Years and Weighing ≥40 kg:
Dose Recommended in FDA EUA for PEP for Individuals With Ongoing Exposure to SARS-CoV-2:
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Sotrovimab (Anti-SARS-CoV-2 Monoclonal Antibody) Authorized for the treatment of COVID-19 under FDA EUA, but distribution has paused in the United States because the Omicron BA.2 subvariant has markedly reduced in vitro susceptibility to SOT. | ||||
Dose Recommended in FDA EUA for Treatment of COVID-19 in Adults and Pediatric Patients Aged ≥12 Years and Weighing ≥40 kg:
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Tixagevimab Plus Cilgavimab (Evusheld) (Anti-SARS-CoV-2 Monoclonal Antibodies) Authorized for PrEP of COVID-19 under FDA EUA. | ||||
Doses Recommended in EUA for PrEP of COVID-19 in Adults and Pediatric Patients Aged ≥12 Years and Weighing ≥40 kg:
For patients who previously received a dose of TIX 150 mg plus CIL 150 mg, administer a second dose per the following criteria as soon as possible:
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COVID-19 Convalescent Plasma Authorized for the treatment of COVID-19 under FDA EUA. | ||||
Dose Recommended in FDA EUA for Treatment of COVID-19:
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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:
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Key: AE = adverse event; BAM = bamlanivimab; BEB = bebetelovimab; CAS = casirivimab; CIL = cilgavimab; CP = convalescent plasma; CYP = cytochrome P450; ETE = etesevimab; EUA = Emergency Use Authorization; FDA = Food and Drug Administration; HHS = U.S. Department of Health and Human Services; IM = intramuscular; IMD = imdevimab; IV = intravenous; the Panel = the COVID-19 Treatment Guidelines Panel; PEP = post-exposure prophylaxis; PrEP = pre-exposure prophylaxis; RBC = red blood cell; SOT = sotrovimab; SUBQ = subcutaneous; TACO = transfusion-associated circulatory overload; TIX = tixagevimab; TRALI = transfusion-related acute lung injury; VOC = variant of concern |
References
- Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization for bebtelovimab. 2022. Available at: https://www.fda.gov/media/156152/download.
- Food and Drug Administration. Fact sheet for healthcare providers: emergency use authorization for Evusheld (tixagevimab co-packaged with cilgavimab). 2022. Available at: https://www.fda.gov/media/154701/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. Fact sheet for health care providers: emergency use authorization (EUA) of COVID-19 convalescent plasma for treatment of coronavirus disease 2019 (COVID-19). 2021. Available at: https://www.fda.gov/media/141478/download.