Bebtelovimab works by binding to the spike protein of the virus that causes COVID-19, similar to other monoclonal antibodies that have been authorized for the treatment of high-risk people with mild to moderate COVID-19 and shown a benefit in reducing the risk of hospitalization or death. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. 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. . 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. Bebtelovimab is a monoclonal antibody treatment that had its FDA authorization paused in November 2022. All . ).1, In the BLAZE 4 study, extension sets could have been primed with either study drug or normal saline if allowed by site practices.3, Bebtelovimab Fact Sheet for Health Care Providers. Please turn on JavaScript and try again. The .gov means its official.Federal government websites often end in .gov or .mil. 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. If immediate administration is not possible, store the syringe for up to 24 hours at refrigerated temperature (2C to 8C [36F to 46F]) and up to 7 hours at room temperature (20C to 25C [68F to 77F]). Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 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. For patients, the infusion is free (for now). . Monoclonal antibody therapy is an effective treatment and has proven to: 70%-85% Monoclonal antibodies, such as bebtelovimab, may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring high-flow oxygen or mechanical ventilation. All rights reserved. The procedure followed for aseptic technique may vary between institutions. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Requires a 60-minute post-infusion monitoring period Bebtelovimab has a warnings for: Hypersensitivity including anaphylaxis and infusion-related reactions May occur up to 24 hours after infusion May be severe and life threatening Clinical worsening of COVID-19 after administration Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. The Food and Drug Administration last month authorized using the combination monoclonal antibody therapy Evusheld (tixagevimab co-packaged with cilgavimab) to help prevent COVID-19 in certain adults and children with compromised immune systems or a history of severe adverse reaction to a COVID-19 vaccine or its components. The EUA has since been revoked on November 30, 2022. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. | Lilly USA, LLC 2023. Share cases and questions with Physicians on Medscape consult. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . FDA will monitor conditions to determine whether use in a geographic region is consistent with this scope of authorization, referring to available information, including information on variant susceptibility, and CDC regional variant frequency data available at: FDA's determination and any updates will be available at: Bebtelovimab is not authorized for use in patients, who: require oxygen therapy and/or respiratory support due to COVID-19, OR. PP-BB-US-0005 11/2022 Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. Issued February 11, 2022. There are other authorized treatments available and healthcare providers should choose an authorized therapeutic option with activity against the circulating variants in their state, territory, or US jurisdiction. Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). This content does not have an Arabic version. A new investigational treatment for COVID-19: The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. If you log out, you will be required to enter your username and password the next time you visit. See Limitations of Authorized Use. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. This site is intended for US residents aged 18 or older. Identify an infusion center near your patient. Bebtelovimab should be administered via IV injection over at least 30 seconds. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. Drug class: Miscellaneous antivirals. more serious infusion related hypersensitivity reactions. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download Discard any product remaining in the vial. After the entire contents of the syringe have been administered. 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): The following provides essential safety information on the unapproved use of bebtelovimab under the Emergency Use Authorization. Infusion reactions have happened during and within 24 hours after the infusion. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. bebtelovimab 175mg, bamlanivimab 700 mg and etesevimab 1400 mg administered together (total dose volume 62.5 mL) via IV infusion over at least 6.5 minutes. Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Tell your doctor right away if you feel confused, tired, or weak. Bebtelovimab has a half-life of 11.5 days, which may explain the consistent bradycardia and hypotension post cardiac arrest and the need for pressors ( 7 ). Older age, with or without other conditions, also places people at higher risk of being hospitalized for COVID-19. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. with positive results of direct SARS-CoV-2 viral testing. Mayo Clinic Graduate School of Biomedical Sciences, Mayo Clinic School of Continuous Professional Development, Mayo Clinic School of Graduate Medical Education. 1-800-LILLYRX Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. See Prescribing Information above, if applicable. Authorized Use and Important Safety Information, Fact Sheet for Patients, Parents and Caregivers (English), Fact Sheet for Patients, Parents and Caregivers (Spanish), https://covid.cdc.gov/covid-data-tracker/#variant-proportions, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs. The drug, called bebtelovimab from Eli Lilly, is a monoclonal therapy meant for COVID-19 patients as young as 12 who are at high risk for getting severely ill and who were recently infected, to keep them from getting even sicker and keep them out of the hospital. Patients treated with bebtelovimab should continue to self-isolate and use infection control measures (e.g., wear mask, isolate, social distance, avoid sharing personal items, clean and disinfect high touch surfaces, and frequent handwashing) according to CDC guidelines. Information about circulating variants can be found through Nowcast data. Veklury is approved for the treatment of adults and pediatric patients (28 days of age and older and weighing at least 3 kg) with positive results of direct SARS-CoV-2 viral testing, who are:. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. 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. Some of these events required hospitalization. Bebtelovimab No Longer Authorized as of 11/30/22. Please also see the FDA Letter of Authorization and the Fact Sheet for Patients, Parents and Caregivers on the authorized use of bebtelovimab. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. At this time, bebtelovimab remains authorized in all U.S. regions until further notice by FDA. Download Your healthcare provider may talk with you about clinical trials for which you may be eligible. COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. Administer the entire contents of the syringe via intravenous (IV) injection over at least 30. See Limitations of Authorized Use. Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Bebtelovimab-Induced Bradycardia Leading to Cardiac Arrest Crit Care Explor. As of 11/30/2022, the Centers for Disease Control and Prevention (CDC) estimated the proportion of COVID-19 cases to be caused by the Omicron subvariant BQ.1 and BQ.1.1to be above 50% in all U.S. Department of Health and Human Services (HHS) regions. Resources may contain information about doses, uses, formulations and populations different from product labeling. 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