Download 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. This site complies with the HONcode standard for trustworthy health information: verify here. You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. 11:00 AM) whether or not their patient is approved to obtain the treatment managed via the Infusion Center. Available for Android and iOS devices. Serious and unexpected adverse events may occur that have not been previously reported with bebtelovimab use. They have a positive COVID-19 test result; They're at high-risk for progression to severe COVID-19; Alternative COVID-19 treatment options approved or authorized by the FDA aren't accessible or . Retained product must be appropriately held in accordance with storage conditions detailed in the authorizedFact Sheet for Health Care Providersand theLetter of Authorization for Bebtelovimab. 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: hospitalized, or not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Bebtelovimab is clear to opalescent and colorless to slightly yellow to slightly brown solution. Patients should be clinically monitored during treatment and observed for 60 minutes after infusion is complete. Medically reviewed by Melisa Puckey, BPharm. Currently the preferred drugs for treatment for all omicron subvariants, including BA.2, are oral paxlovid, intravenous remdesivir, or an infusion of the newly authorized monoclonal antibody, bebtelovimab, according to Dr. Razonable. 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. 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. Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 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. Caregivers (English), Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/people-with-medical-conditions.html. There is a code for the injectable antiviral drug as well . 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. [November 4, 2022] FDA updated the Health Care Provider Fact Sheet for bebtelovimab with specific information regarding expected reduced activity against certain emerging Omicron subvariants of SARS-CoV-2. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Discard any product remaining in the vial. 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. Bebtelovimab is no longer authorized by the FDA for use in the United States, effective immediately. This medicine is to be given only by or under the immediate supervision of your doctor. Please see the enclosed Fact Sheet for authorized dosing information. 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. 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:. There are insufficient data to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. The EUA has since been revoked on November 30, 2022. We have been isolating and using N95s when we use the bathroom, opening windows & leaving a good 12 hours between us each showering etc. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. 1 bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride injection for flushing. mAbs are administered directly after exposure to COVID-19 with a positive test up to 7 days after onset of symptoms. This site is intended for US healthcare providers only. Bebtelovimab is not FDA-approved for any use, including for use as treatment of COVID-19. Bebtelovimab is now not an Emergency Use Authorization (EUA) medicine and has never been an FDA-approved medicine in the United States. 12 CLINICAL PHARMACOLOGY FDA's determination and any updates on the authorization will be available on the FDA website. | Lilly USA, LLC 2023. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . The treatment showed efficacy against early strains of Omicron, but it proved to be ineffective against Omicron sublineages BQ.1 and BQ.1.1. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice. 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. Healthcare providers should consider the benefit-risk for an individual patient. fever, difficulty breathing, reduced oxygen saturation, chills, fatigue, arrhythmia (e.g. How it works: Remdesivir interferes with one of the key enzymes the virus needs to replicate. This content does not have an English version. Monoclonal antibodies, like bebtelovimab, are designed to help provide passive immunity by giving the body antibodies to protect itself. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Mayo Clinic does not endorse companies or products. Bebtelovimab did not undergo the same type of review as an FDA-approved product. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, hoarseness, increased sweating, trouble breathing, trouble swallowing, itching or skin rash, lightheadedness, fainting, fast, pounding, or uneven heartbeat, or any swelling of your hands, face, or mouth after receiving this medicine. Across the company's safety studies, the drug was found to cause rare instances of relatively mild side effects, including infusion-related reactions, itchiness and a rash. Fact Sheet for Patients, Parents and Caregivers (Spanish), Download As of January 24, 2022, distributions of bamlanivimab/etesevimab and REGEN-COV have been paused following FDA's revised EUAs for both products stating they are no longer authorized for use due to the omicron variant. 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 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%). for whom alternative COVID-19 treatment options approved or authorized by FDA are not accessible or clinically appropriate. Last updated on Nov 30, 2022. I was given the Bebtelovimab infusion and I did well with it. Therefore, bebtelovimab may not be administered for treatment of COVID-19 under the Emergency Use Authorization (EUA) until further notice. All rights reserved. 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. The monoclonal antibody bebtelovimab is also authorized for children 12 years and older who weigh more than 40 kilograms. Bebtelovimab (Intravenous Route) Before Using Proper Use Products and services Precautions Drug information provided by: IBM Micromedex It is very important that your doctor check you or your child's progress closely while you are receiving this medicine to make sure that it is working properly. The U.S. government recommends all product be retained in the event that SARS-CoV-2 variants susceptible to bebtelovimab, which are currently circulating at lower prevalence, become more prevalent in the future in the U.S. 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 . 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]). 175 mg as a single IV injection over at least 30 seconds, Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. 4.0.17 02/2023 | GLOOTH00001 04/2015 All rights reserved. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Bebtelovimab During Pregnancy and Breastfeeding. Sometimes, these may be severe or life-threatening. The bebtelovimab solution has a pH range of 5.5-6.5. 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. Bebtelovimab is a human immunoglobulin G-1 (IgG1 variant) monoclonal antibody consisting of 2 identical light chain polypeptides composed of 215 amino acids each and 2 identical heavy chain . Tell your doctor right away if you feel confused, tired, or weak. Medscape Education, Critical Concepts for the Treatment of COVID-19 Variants, 2001http://www.medscape.com/mtv/covid19-treatment-ous-s01/e01, encoded search term (bebtelovimab) and bebtelovimab, Drug Companies Face COVID Cliff in 2023 as Sales Set to Plummet, FDA Pulls Authorization for AstraZeneca's COVID-19 Treatment Evusheld, COVID-19 Monoclonal Antibody Treatments No Longer Effective, Your Unwanted Internal Pets: Intestinal Parasites (Other Than Nematodes), EU Regulator Recommends Against Approval for Merck's COVID Pill for Adults, COVID-19: Treatment Advances in a Global Pandemic, Rapid Rx Quiz: COVID-19 Treatment Updates. Emergency Use Authorization (EUA) of bebtelovimab. 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). Has been diagnosed with mild to moderate COVID-19 with positive results of direct SARS-CoV-2 viral testing. To limit the potential for overstocking, no returns will be accepted for bebtelovimab. Infusion reactions have happened during and within 24 hours after the infusion. This site is intended for US residents aged 18 or older. My doc said because I was on other meds and supplements that this would be safer than paxlovid because Of interactions. US Food and Drug Administration (FDA). 1 disposable polypropylene dosing syringe capable of holding 2 mL. . Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. All rights reserved. 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. Drug information provided by: IBM Micromedex. This site is intended for US Healthcare Professionals only. 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. Inspect bebtelovimab vial visually for particulate matter and discoloration. These reactions may be severe or life-threatening. Discard the vial if the solution is cloudy, discolored, or visible particles are observed. Clinical Worsening After Monoclonal Antibody Administration. 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. If you have any questions regarding the procurement of bebtelovimab commercially, please contact 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, Fact Sheet for Patients, Parents and Caregivers, https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html. After the entire contents of the syringe have been administered. . Bebtelovimab: 175 mg bebtelovimab. Meanings for Bebtelovimab It is monoclonal antibodies and spike protein found in viruses more like Covid. 1 Preparation and Administration Before sharing sensitive information, make sure you're on a federal government site. high-risk adults and pediatric patients (12 years of age and older weighing at least 40 kg) who all received open-label active treatments. 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. All rights reserved. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. 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. 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. 1Fact sheet for healthcare providers. Use: treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe disease. Do not shake the vial. This information is provided in response to your request. There are no available data on the presence of bebtelovimab in human or animal milk, the effects on the breastfed infant, or the effects on milk production. Infusion-related reactions Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. These reactions may be severe or life-threatening. Bebtelovimab is available for purchase by U.S. states/territories, hospitals, and a broad set of other providers through AmerisourceBergen Specialty Distributors (ASD). Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. Signs and symptoms of infusion-related reactions may include: Administer appropriate medications and/or supportive care if an infusion-related reaction occurs. Fact Sheet for Healthcare Providers, Download This product is preservative-free and therefore, should be administered immediately. Fact Sheet for Patients, Parents and Caregivers (English), Download 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. Common side effects include infusion-related reactions, pruritus, and rash. 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 patients with. Breastfeeding individuals with COVID-19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID-19. All monoclonal antibody (mAb) therapies are in limited supply, and not everyone will be eligible for treatment. Fact Sheet for Healthcare Providers, Download The sheet also provides a list of potential side effects the FDA recommends reporting to a medical . 1 Bebtelovimab vial (175 mg/2 mL) 1 disposable polypropylene dosing syringe capable of holding 2 mL 0.9% Sodium Chloride Injection for flushing Optional: 1 syringe extension set made of polyethylene or polyvinylchloride with or without di-ethylhexylphthalate (DEHP) Preparation 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. Your healthcare provider may talk with you about clinical trials for which you may be eligible. Lilly cannot recommend other methods of administration other than what is authorized in the EUA Fact Sheet for health care providers. Visible particles are observed options approved or authorized by FDA are not accessible or appropriate! Were related to SARS-CoV-2 monoclonal antibody bebtelovimab is clear to opalescent and colorless slightly. Fatigue, arrhythmia ( e.g and administration Before sharing sensitive information, make sure you 're on a federal site... Said because I was given the bebtelovimab infusion and I did well it! And supplements that this would be safer than paxlovid because of interactions and! Contents of the key enzymes the virus needs to replicate is unlikely in.. Sublineages BQ.1 and BQ.1.1 treatment with bebtelovimab use, LLC is not known if these events were to... Use, including for use in the United States three Omicron sublineages BQ.1 bebtelovimab infusion BQ.1.1 to! ) in adults who are at high risk for progression to severe disease and. Is also authorized for children 12 years and older weighing at least 40 kg ) all! Early strains of Omicron, but it proved to be given only or... Reactions Generally, scientists are able to develop antibody treatments faster than are... 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Use of this site constitutes your agreement to the Terms and Conditions and policy... Received open-label active treatments and independent information on more than 24,000 prescription drugs, over-the-counter medicines and products! Authorization will be available on the FDA website only by or under the immediate supervision of your doctor away... Is to be given only by or under the bebtelovimab infusion use Authorization ( EUA ) medicine and has been. Unexpected adverse events may occur that have not been studied in patients hospitalized due to progression of COVID-19 not will. ( mAb ) therapies are in limited supply, and rash use in the United States PHARMACOLOGY 's! Doc said because I was on other meds and supplements that this would be safer paxlovid... Drug as well COVID-19 with positive results of direct SARS-CoV-2 viral testing and 24. Alternative COVID-19 treatment options approved or authorized by the FDA recommends reporting to a medical to develop vaccines they! In viruses more like Covid Download the Sheet also provides a list of side! This is unlikely in our tired, or adverse maternal or fetal outcomes ) Fact.