When issuing an EUA under the COVID-19 public health emergency, the FDA determined, among other things, that based on the total amount of scientific evidence available, including data from adequate and well-controlled clinical trials, it is reasonable to believe that the product may be effective for diagnosing, treating, or preventing COVID-19, or a serious or life-threatening disease or condition caused by COVID-19; that the known and potential benefits of the product, when used to diagnose, treat, or prevent such disease or condition, outweigh the known and potential risks of such product; and that there are no adequate, approved and available alternatives. Bebtelovimab is not authorized for treatment of mild-to-moderate COVID-19 in geographic regions where infection is likely to have been caused by a non-susceptible SARS-CoV-2 variant based on available information including variant susceptibility to this drug and regional variant frequency. A: Generally acceptable. All rights reserved. Share cases and questions with Physicians on Medscape consult. Current variant frequency data are available here. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. This site complies with the HONcode standard for trustworthy health information: verify here. If used, attach and prime the syringe extension set. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. Drug class: Miscellaneous antivirals. Sometimes, these may be severe or life-threatening. We comply with the HONcode standard for trustworthy health information. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. pre-syncope, syncope), dizziness, and diaphoresis. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Controlled studies in pregnant women show no evidence of fetal risk. Healthcare providers should consider the benefit-risk for an individual patient. These errors build up over time until the virus is no longer capable of surviving. Tell your doctor right away if you feel confused, tired, or weak. Use the yellow button below to refer patients directly for infusion treatment. The new monoclonal antibody treatment, bebtelovimab, is manufactured by Eli Lilly and Company, and if it receives emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA), HHS will make the treatment available to states free of charge. Copyright 2023 IBM Watson Health. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Bebtelovimab is authorized to be administered for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg): Circulating SARS-CoV-2 viral variants may be associated with resistance to monoclonal antibodies. Please also reference the Fact Sheet for Healthcare Providers for more information. The EUA for bebtelovimab is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms, which is about 88 pounds) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in pediatric patients (12 years of age and weighing at least 40 kg) who are at high risk for progression to severe disease. FDA's determination and any updates on the authorization will be available on the FDA website. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. This medicine is to be given only by or under the immediate supervision of your doctor. The 12 codes are from the New Technology Section X of ICD-10-PCS and are available in the table below. Mayo Clinic on Incontinence - Mayo Clinic Press, NEW The Essential Diabetes Book - Mayo Clinic Press, NEW Ending the Opioid Crisis - Mayo Clinic Press, FREE Mayo Clinic Diet Assessment - Mayo Clinic Press, Mayo Clinic Health Letter - FREE book - Mayo Clinic Press. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. The Florida Department of Health COVID-19 Response Map has been updated to make it easier to find testing, vaccine and treatment sites across the state. These reactions may be severe or life-threatening. Lilly USA, LLC 2022. Bebtelovimab may only be administered in settings in which health care providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In laboratory experiments involving 19 monoclonal antibodies, only the recently authorized bebtelovimab was found to be capable of neutralizing all three sublineages of the Omicron variant, according to a study published in Nature. Avoid forming air bubbles. Withdraw 2 mL from the vial into the disposable syringe. This product is available in the following dosage forms: Portions of this document last updated: Feb. 01, 2023. Issued February 11, 2022. It is used by people 12 years of age and older who have recently tested positive for. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Before sharing sensitive information, make sure you're on a federal government site. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. See more information regarding dosing in the. Bebtelovimab is not currently authorized in any U.S. region due to the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab. Before receiving treatment, tell your healthcare provider about all your or your childs medical conditions including if you or your child: Interactions between bebtelovimab and other drugs are unlikely. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). The EUA has since been revoked on November 30, 2022. more serious infusion related hypersensitivity reactions. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Adverse reactions observed in those who have received bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, are infusion-related reactions (n=2, 0.3%), pruritus (n=2, 0.3%) and rash (n=5, 0.8%). However . FDA Letter of Authorization. Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. This site is intended for US healthcare providers only. Federal regulators on February 11 authorized a new monoclonal antibody treatment for mild-to-moderate COVID-19. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 360bbb-3, unless the authorization is terminated or revoked sooner.1,2, Bebtelovimab is authorized for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg), For information on the authorized use of bebtelovimab and mandatory requirements under the emergency use authorization (EUA), please review the FDA Letter of Authorization, Fact Sheet for Healthcare Providers, and Fact Sheet for Patients/Caregivers at www.LillyAntibody.com/bebtelovimab. These reactions may be severe or life threatening. Do not shake the vial. Download The right medications for COVID-19 can help. The EUA for bebtelovimab was in effect until revoked due it not being expected to neutralize the current Omicron subvariants BQ.1 and BQ.1.1, therefore bebtelovimab can no longer be used under the EUA. To find COVID-19 vaccine locations near you: Search vaccines.gov, text your ZIP code to 438829, or call 1-800-232-0233. Codes are available for the introduction or infusion of Remdesivir, Sarilumab, Tocilizumab, or other therapeutic substances, as well as the transfusion of convalescent plasma specifically for the treatment of COVID-19. Drug Safety and Availability, Recalls, Market Withdrawals and Safety Alerts, Information about Nitrosamine Impurities in Medications, Food and Drug Administration Overdose Prevention Framework, Medication Errors Related to CDER-Regulated Drug Products, Postmarket Drug Safety Information for Patients and Providers, Risk Evaluation and Mitigation Strategies | REMS, Multistate outbreak of fungal meningitis and other infections, Health Care Provider Fact Sheet for bebtelovimab. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. The EUA was supported by a Secretary of Health and Human Service (HHS) declaration that circumstances exist to justify the emergency use of drugs and biological products during the COVID-19 pandemic. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. The emergency use of bebtelovimab is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. Bebtelovimab . Details About the 2020 Codes I had what they considered moderate symptoms & am 41 with a healthy pregnancy. Assess that alternative COVID-19 treatment options that are approved or authorized by FDA are not accessible or clinically appropriate. Clinical Criteria and Data Requirements for Patient: (Must complete each item as appropriate) All of these criteria must be met to allow for the product to be used in the treatment of patients during the COVID-19 pandemic. Blood tests may be needed to check for unwanted effects. Hypersensitivity reactions occurring more than 24 hours after the injection have also been reported with the use of SARS-CoV-2 monoclonal antibodies under Emergency Use Authorization. PP-BB-US-0005 11/2022 Bebtelovimab may only be administered in settings in which healthcare providers have immediate access to medications to treat a severe infusion reaction, such as anaphylaxis, and the ability to activate the emergency medical system (EMS), as necessary. Other risk factors can be found on the CDC website. Descriptions Bebtelovimab injection is used to treat mild to moderate coronavirus disease 2019 (COVID-19) in patients with positive results of direct SARS-CoV-2 testing, who are at high risk for progression to severe COVID-19 (eg, hospitalization, death), and for whom other treatments are not available or appropriate. Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. You can get COVID19 through contact with another person who has the virus. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. If you log out, you will be required to enter your username and password the next time you visit. Resources may contain information about doses, uses, formulations and populations different from product labeling. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Please confirm that you would like to log out of Medscape. Lilly USA, LLC 2022. Or revoked sooner following dosage forms: Portions of this document last updated Feb.. Treatment with bebtelovimab has not been studied in Patients with severe COVID-19 an individual patient limitations Benefit! 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