bebtelovimab infusion

Fact Sheet for Healthcare Providers, Download US Food and Drug Administration (FDA). Generic name: bebtelovimab Bebtelovimab - Last updated on December 12, 2022 All rights owned and reserved by Memorial Sloan Kettering Cancer Center. The information presented in the section below contains data on unauthorized preparation and administration of bebtelovimab. are likely to be infected with a SARS-CoV-2 variant that is not able to be treated by bebtelovimab based on the circulating variants in your area (ask your health care provider about FDA and CDCs latest information on circulating variants by geographic area). All rights reserved. Generally, scientists are able to develop antibody treatments faster than they are able to develop vaccines. If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue administration, and initiate appropriate medications and/or supportive care. Bebtelovimab . COVID-19 illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. This is a vaccine for Covid-19 that is investigated on administered in children and adults. 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. INDIANAPOLIS, June 29, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) . Bebtelovimab continues to maintain neutralization against all known variants of interest and concern. Advertising revenue supports our not-for-profit mission. Available for Android and iOS devices. Information is for End User's use only and may not be sold, redistributed or otherwise used for commercial purposes. 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. Important points to this press release: "Severe hypersensitivity reactions and infusion-related reactions, have been observed with administration of bebtelovimab, including in pregnant patients. 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. In a statement the FDA said that it was "carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies . Administer as soon as possible after positive results of direct SARS-CoV-2 viral testing and within 7 days of symptom onset. Medically reviewed by Melisa Puckey, BPharm. eCollection 2022 Aug. Use the filters to find locations for vaccines, testing and treatments for COVID-19 near you. 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. A prescription from a healthcare provider is required to receive any mAb therapy. They can now be given through subcutaneous or intramuscular injections rather than as an infusion at a hospital. 200 Independence Ave., Washington, DC 20201. All rights reserved. Discard the vial if the solution is cloudy, discolored, or . 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. Copyright 2023 IBM Watson Health. Call the infusion center to confirm product availability. require oxygen therapy and/or respiratory support due to COVID-19. The site is secure. 1998-2023 Mayo Foundation for Medical Education and Research (MFMER). Clinical worsening of COVID-19 after administration of SARS-CoV-2 monoclonal antibody treatment has been reported and may include signs or symptoms of fever, hypoxia or increased respiratory difficulty, arrhythmia (e.g., atrial fibrillation, sinus tachycardia, bradycardia), fatigue, and altered mental status. 12 CLINICAL PHARMACOLOGY You will be observed by your healthcare provider for at least 1 hour after you receive bebtelovimab. COVID-19 is caused by a virus called a coronavirus (SARS-CoV-2). Eli Lilly's bebtelovimab has been shown to work against both BA.1 and BA.2.7 Authorised by the FDA in February,8 the treatment is for mild to moderate covid-19 in high risk people aged over 12. These reactions may be severe or life-threatening. 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. 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. These are not all the possible side effects. This site is intended for US residents aged 18 or older. 3Data on file, Eli Lilly and Company and/or one of its subsidiaries. Lilly USA, LLC 2022. Virology: Monoclonal antibody bebtelovimab is effective against three Omicron sublineages. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Bebtelovimab has been associated with anaphylactic reactions; however, this is unlikely in our . Other risk factors can be found on the CDC website. Treatment with bebtelovimab has not been studied in patients hospitalized due to COVID-19. Thresholds, Orders, and Replenishment by Jurisdiction, HHS, Administration for Strategic Preparedness and Response (ASPR) Eli Lilly and Company (Lilly) does not provide an aseptic technique directive for the preparation of thebebtelovimabsolution for infusion. BA.5 became the dominant subvariant in the US earlier this month, surpassing BA.2.12.1. 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. This medicine may cause serious allergic reactions, including infusion-related reactions and anaphylaxis, which can be life-threatening and require immediate medical attention. 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. | Lilly USA, LLC 2023. Any use of this site constitutes your agreement to the Terms and Conditions and Privacy Policy linked below. Bebtelovimab is a medication that the FDA is allowing to be given for emergency use to treat COVID-19. Clinical Worsening After Monoclonal Antibody Administration. Details About the 2020 Codes The right medications for COVID-19 can help. Positive results of direct acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing. https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvYmVidGVsb3ZpbWFiLTQwMDAyNzM=. Bebtelovimab is designed as a treatment option for those newly diagnosed with COVID-19 who cannot take Paxlovid and are deemed at high risk of severe outcomes. 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]). The EUA has since been revoked on November 30, 2022. 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. Clinicians caring for COVID-19 patients should be aware of the availability of these important life-saving medications and consider use when clinically indicated. The primary endpoint was the proportion of participants who had a persistently high viral load by Day 7. For a mother and unborn baby, the benefit of receiving bebtelovimab may be greater than the risk from the treatment. online here. Issued February 11, 2022. 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. A healthcare worker attaches an IV infusion to a patient's hand during a monoclonal antibody treatment in the parking lot at Wayne Health Detroit Mack Health Center in Detroit, Michigan, U.S., on . However . . One dose given per day for 3 days. 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. There is a code for the injectable antiviral drug as well . The .gov means its official.Federal government websites often end in .gov or .mil. 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 ). All material on this website is protected by copyright, Copyright 1994-2023 by WebMD LLC. Share cases and questions with Physicians on Medscape consult. with positive results of direct SARS-CoV-2 viral testing. 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. How do you prepare, administer, and monitor bebtelovimab for treatment of COVID-19? This site complies with the HONcode standard for trustworthy health information: verify here. Advertising revenue supports our not-for-profit mission. In the BLAZE-4 clinical trial, bebtelovimab was administered via IV infusion or IV push.3, In the Phase 1 portion of the study, faster infusion rates of bebtelovimab or bebtelovimab administered with bamlanivimab and etesevimab were not associated with an increasing number and/or severity of treatment-emergent adverse events.3, Informed by this data, bebtelovimab was administered to patients at high-risk for severe disease with an IV injection of at least 30 seconds while bebtelovimab with bamlanivimab and etesevimab was administered over at least 6.5 minutes.3, The study data from BLAZE-4 supports administration via IV push over 30 seconds, which is the authorized administration for bebtelovimab under the EUA.1,3, Considering bebtelovimab can be administered over 30 seconds, IV push of the medication saves considerable time relative to the preparation and administration of an IV infusion and may facilitate greater treatment capacity and flexibility throughout infusion centers.3, There is no sufficient data available to support the administration of bebtelovimab via subcutaneous or intramuscular dosing.3. 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. To ensure there is no break in availability of bebtelovimab to states/territories and providers, HHS has coordinated with Lilly to enable the transition from US government distributed supply to commercially available supply. It is not known if these events were related to SARS-CoV-2 monoclonal antibody use or were due to progression of COVID-19. Healthcare providers can consider the benefit-risk for an individual patient, using the Fact Sheet for Healthcare Providers and the CDC website as guidance. who are at high risk for progression to severe COVID-19, including hospitalization or death, and. 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. Serious and unexpected side effects may happen. The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Accessed February 11, 2022. http://pi.lilly.com/eua/bebtelovimab-eua-fda-authorization-letter.pdf. Bebtelovimab The link you clicked on will take you to a site maintained a! For an individual patient, using the fact Sheet for healthcare Providers, Download US Food and Administration... Criteria must be met to allow for the product to be given through subcutaneous or intramuscular rather... For Medical Education and Research ( MFMER ) Lilly and Company ( NYSE: LLY ) has not been in... This website is protected by copyright, copyright 1994-2023 by WebMD LLC SARS-CoV-2 viral bebtelovimab infusion and treatments for COVID-19 should. ; carefully monitoring circulating viral variants and their sensitivity to authorised monoclonal antibodies can consider the for! This medicine may cause serious allergic reactions, including illness resulting in death,! 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