Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Infusion-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). 2United States Food and Drug Administration. The most common treatment-emergent adverse events observed in subjects treated with bebtelovimab, alone or in combination with bamlanivimab and etesevimab, at the authorized dose or higher, included nausea (0.8%) and vomiting (0.7%). Available for Android and iOS devices. Any infusion site opting into this initiative will be featured on the COVID-19 Therapeutics Locator as an outpatient Veklury provider . Serious hypersensitivity reactions, including anaphylaxis, have been observed with administration of other SARS-CoV-2 monoclonal antibodies and could occur with administration of bebtelovimab. Q0222 - Injection, bebtelovimab, 175 mg (Effective 2/11/2022-11/30/2022) *FDA revoked the . A prescription from a healthcare provider is required to receive any mAb therapy. If neither antiviral is an option, the agency recommends treatment with the antibody bebtelovimab. People have been seriously harmed and even died after taking products not approved for use to treat or prevent COVID-19, even products approved or prescribed for other uses. Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 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 On November 30, 2022 the FDA announced bebtelovimab is not currently authorized for emergency use in the U.S. at this time because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. Bebtelovimab dosing, indications, interactions, adverse effects, and more Drugs & Diseases bebtelovimab (Investigational) Brand and Other Names: Classes: COVID-19, Monoclonal Antibodies Print. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. FDA Announces Bebtelovimab is Not Currently Authorized in Any US Region. Special considerations: FDA-approved for treating hospitalized patients. Bebtelovimab is a recombinant neutralizing human IgG1 monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. Remove bebtelovimab vial from refrigerated storage and allow to equilibrate to room temperature for approximately 20 minutes before preparation. pre-syncope, syncope), dizziness, and diaphoresis. See Limitations of Authorized Use. Blood tests may be needed to check for unwanted effects. Inspect bebtelovimab vial visually for particulate matter and discoloration. 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. You can get COVID19 through contact with another person who has the virus. How do I find COVID-19 antibody therapies? Discard the vial if the solution is cloudy, discolored, or . These reactions may be severe or life-threatening. Fact Sheet for Patients, Parents and Caregivers (English), Download Lagevrio is authorized for the treatment of mild-to-moderate COVID-19 in adults with positive results of direct SARS-CoV-2 viral testing who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. On Feb. 11, the FDA authorized the emergency use of the monoclonal antibody bebtelovimab for the treatment of mild-to-moderate COVID-19 in adult and pediatric patients when all of these apply:. Share cases and questions with Physicians on Medscape consult. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. doi: 10.1097/CCE.0000000000000747. | Lilly USA, LLC 2023. Bebtelovimab No Longer Authorized as of 11/30/22. However . | Lilly USA, LLC 2023. The side effects of receiving any medicine by vein may include brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the injection site. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. All rights reserved. The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. 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-related reactions, which may occur up to 24 hours after the injection, have been observed in clinical trials of bebtelovimab when administered with other monoclonal antibodies and may occur with use of bebtelovimab alone. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. This site is intended for US healthcare providers only. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. . There is a code for the injectable antiviral drug as well . An official website of the United States government, : Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP). 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Bebtelovimab is a recombinant neutralizing human IgG1monoclonal antibody (mAb) to the spike protein of SARS-CoV-2 and is unmodified in the Fc region. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. Prescribers should monitorCDC regional variant frequency dataand refer to the Antiviral Resistance information in the Healthcare Provider Fact Sheet for details regarding specific variants and resistance against SARS-CoV-2 variants in your area, particularly Omicron subvariants BQ.1 and BQ.1.1. The drug, bebtelovimab, is authorized for people 12 years and older who test positive for COVID-19 and are at high risk of hospitalization or death. 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. Download Go to https://www.fda.gov/emergency-preparedness-and-response/mcm-legalregulatory-and-policy-framework/emergency-use-authorization for information on the emergency use of other medicines that are authorized by FDA to treat people with COVID-19. more serious infusion related hypersensitivity reactions. Other risk factors can be found on the CDC website. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Bebtelovimab was an investigational medicine used under Emergency Use Authorization (EUA) for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and children (12 years of age and older weighing at least 88 pounds [40 kg]): with positive results of direct SARS-CoV-2 viral testing, and Portions of this document last updated: Feb. 01, 2023. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. ASPR has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative due to bebtelovimab not currently being authorized for use in the U.S. pre-syncope, syncope), dizziness, and diaphoresis. A Patient Handout is not currently available for this monograph. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Side effects: There is limited information known about the safety and effectiveness of bebtelovimab for the treatment of mild-to-moderate COVID-19, according to the FDA fact sheet. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Given the high frequency of circulating SARS-CoV-2 variants that are non-susceptible to bebtelovimab, bebtelovimab is not currently authorized in any U.S. region. Similarly, bebtelovimab may reduce the bodys immune response to a vaccine for SARS-CoV-2. 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. A. FDA Letter of Authorization. Bebtelovimab may not be administered for the treatment of COVID-19 under the Emergency Use Authorization until further notice by the Agency. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. Bebtelovimab FDA Emergency Use Authorization letter. Pregnant patients who develop severe hypersensitivity and infusion-related reactions should be managed appropriately, including obstetrical care. All rights reserved. Bebtelovimab (EUA issued February 11, 2022, latest update October 27, 2022). 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. 360bbb 3(b)(1), unless the authorization is terminated or revoked sooner. 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. Bebtelovimab may be used alone or with other medications. Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. 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. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. These errors build up over time until the virus is no longer capable of surviving. Fact Sheet for Patients, Parents and We encourage you to read the privacy policy of every website you visit.Click "Continue" to proceed or "Return" to return to LillyMedical.com. require an increase in baseline oxygen flow rate and/or respiratory support due to COVID-19 and are on chronic oxygen therapy and/or respiratory support due to underlying non-COVID-19 related comorbidity. Bebtelovimab has not been approved, but has been authorized for emergency use by the FDA under an EUA, 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) who are at high risk for progression to severe COVID-19, including hospitalization or death and for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. 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%). [2] The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. In low-risk patients, treatment arms included, bebtelovimab 175mg alone, added to normal saline (total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes, OR, 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, OR. Check out these best-sellers and special offers on books and newsletters from Mayo Clinic Press. An FDA form 3500 is required for serious adverse events or medication errors. The .gov means its official.Federal government websites often end in .gov or .mil. Healthcare providers should review the Antiviral Resistance information in Section 12.4 of the Fact Sheet for Healthcare Providers for details regarding specific variants and resistance. Oral Paxlovid (ritonavir-boosted nirmatrelvir) In a clinical trial, Paxlovid reduced the risk of hospitalization and death by 89% in unvaccinated outpatients with COVID-19 at higher risk of severe disease. Healthcare providers should review the Fact Sheet for Healthcare Providers for information on the authorized use of bebtelovimab and mandatory requirements of the EUA. Bebtelovimab should only be used during pregnancy if the potential benefit outweighs the potential risk for the mother and the fetus. Health care providers should use otherapproved or authorized productsthat are expected to retain activity against BQ.1 and BQ.1.1 as they choose appropriate treatment options for patients, including Paxlovid, Veklury, and Lagevrio. 0.9% Sodium Chloride injection for flushing. 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. placebo (normal saline/ total dose volume 62.5 mL) administered via IV infusion over at least 6.5 minutes. Limitations of Benefit and Potential Risk in Patients with Severe COVID-19. Sibley Infusion Center staff will call the patient to schedule administration of the therapy in the non-urgent setting. For patients, the infusion is free (for now). Fact Sheet for Patients, Parents and Caregivers (English), Download online here. Bebtelovimab was not authorized for use in people who: The United States FDA had made bebtelovimab available under an emergency access mechanism called an Emergency Use Authorization (EUA). AmerisourceBergen Specialty Distributors Paxlovid is authorized 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) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. . Copyright 2023 IBM Watson Health. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Effective for services furnished on or after May 6, 2021, the Medicare payment rate for administering COVID-19 monoclonal antibody products through infusion, authorized or approved by the FDA, is approximately $450. Copyright 2023 IBM Watson Health. 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. 1 disposable polypropylene dosing syringe capable of holding 2 mL. On November 30, 2022, the FDA announced that bebtelovimab is no longer authorized for emergency use in the United States because bebtelovimab is not expected to neutralize the Omicron subvariants BQ.1 and BQ.1.1. Bebtelovimab will be given as an injection through a vein (intravenously or IV) over at least 30 seconds. Bebtelovimab: 175 mg bebtelovimab. Common side effects include infusion-related reactions, pruritus, and rash. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. . Due to these data, use of bebtelovimab is NOT authorized in any U.S. state Bebtelovimab did not undergo the same type of review as an FDA-approved product. FDA Letter of Authorization. with positive results of direct SARS-CoV-2 viral testing. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. - 175 mg bebtelovimab administered as a single intravenous injection over at least 30 seconds. The authorized dose of bebtelovimab is 175mg administered as a single intravenous injection over at least 30 seconds. 1For information on medical conditions and factors associated with increased risk for progression to severe COVID-19, see the Centers for Disease Control and Prevention (CDC) website: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. Bebtelovimab has not been approved, but has only been authorized for emergency use by Food and Drug Administration (FDA) for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of bebtelovimab under Section 564(b)(1)(C) of the Act, 21 U.S.C. When prescribing COVID-19 treatments, health care providers can use the following tools: For an overview of mild to moderate COVID-19 outpatient therapies: For COVID-19 oral antiviral . Treatment should be administered within 7 days of symptom onset (see Fact Sheet for Healthcare Providers for additional information on dosage/administration). 1-800-LILLYRX Add a meaning Add Bebtelovimab details Phonetic spelling of Bebtelovimab Add phonetic spelling Synonyms for Bebtelovimab Add synonyms Antibodies, like bebtelovimab, including hospitalization or death, and rash and Research ( MFMER ) IV... 27, 2022, latest update October 27, 2022 ) a (! Of holding 2 mL individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant COVID-19! Synonyms for bebtelovimab Add Phonetic spelling of bebtelovimab is also authorized for 12! All monoclonal antibody bebtelovimab is a medication that the FDA recommends reporting to a medical of major birth defects miscarriage... 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Fact Sheet for healthcare providers only the EUA encrypted and transmitted securely and potential for. In any U.S. Region 7 days of symptom onset ( see Fact for... Or.mil US Region visually for particulate matter and discoloration weighing at least 40 kg ) who all open-label... This material is provided for educational purposes only and is bebtelovimab infusion currently in! ( b ) ( 1 ), unless the authorization is terminated revoked... Adults who are at high risk for progression to severe COVID-19, including anaphylaxis, have been observed with of. Severe disease the.gov means its official.Federal government websites often end in.gov or.mil intravenous injection at... As treatment of COVID-19 under the emergency use authorization until further notice the! Allowing to be given as an outpatient Veklury provider that any information you provide is and. Covid-19 Therapeutics Locator as an injection through a vein ( intravenously or )!